COVID-19
Conditions
Keywords
ACTT, Adaptive, COVID-19, Efficacy, Multicenter, novel coronavirus, Safety
Brief summary
ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29.
Detailed description
This study is an adaptive randomized double-blind placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. New arms can be introduced according to scientific and public health needs. There will be interim monitoring to allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. This adaptive platform is used to rapidly evaluate different therapeutics in a population of those hospitalized with moderate to severe COVID-19. The platform will provide a common framework sharing a similar population, design, endpoints, and safety oversight. New stages with new therapeutics can be introduced. One independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data in all stages to make recommendations about early study closure or changes to study arms. ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. All subjects will undergo a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Days 1 (prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP swabs and blood (serum only) plus safety laboratory tests will be collected on Day 15 and 29 (if the subject attends an in-person visit or are still hospitalized). The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29. The key secondary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir according to clinical status (8-point ordinal scale) at Day 15. Contacts: 20-0006 Central Contact Telephone: 1 (301) 7617948 Email: DMIDClinicalTrials@niaid.nih.gov
Interventions
DRUGBaricitinib
Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name \[1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl\]acetonitrile. Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
DRUGDexamethasone
Dexamethasone Sodium Phosphate Injection, USP, is an adrenocortical steroid anti-inflammatory drug. It is a water-soluble inorganic ester of dexamethasone. Each mL contains dexamethasone sodium phosphate equivalent to dexamethasone phosphate 4 mg or dexamethasone 3.33 mg; benzyl alcohol 10 mg added as preservative; sodium citrate dihydrate 11 mg; sodium sulfite 1 mg as an antioxidant.
OTHERPlacebo
Placebo matching oral baricitinib or intravenous dexamethasone.
DRUGRemdesivir
Drug remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Hospitalized with symptoms suggestive of COVID-19. 2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures and understands and agrees to comply with planned study procedures. 3. Male or non-pregnant female adult \> / = 18 years of age at time of enrollment. 4. Illness of any duration and has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay (e.g. NAAT, antigen test) in any respiratory specimen or saliva \< / = 14 days prior to randomization. 5. Within the 7 days prior to randomization requiring new use of supplemental oxygen (or increased oxygen requirement if on chronic oxygen) and requires at the time of randomization low or high flow oxygen devices or use of non-invasive mechanical ventilation (ordinal scale category 5 or 6). 6. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29. 7. Agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of COVID-19 through Day 29.
Exclusion criteria
1. Prior enrollment in ACTT-3 or ACTT-4. Note: this includes subjects whose participation in ACTT was terminated early. 2. On invasive mechanical ventilation at the time of randomization (ordinal scale category 7). 3. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours of randomization. 4. Positive test for influenza virus during the current illness (influenza testing is not required by protocol). 5. Subjects with a low glomerular filtration rate (eGFR), specifically: 1. Subjects with an eGFR 15-30 mL/min are excluded unless in the opinion of the PI, the potential benefit of participation outweighs the potential risk of study participation. 2. All subjects with an eGFR \<15 mL/min 3. All subjects on hemodialysis and/or hemofiltration at screening, irrespective of eGFR are excluded. 6. Neutropenia (absolute neutrophil count \<700 cells/microliter, 0.7 x 10\^3/microliter). 7. Lymphopenia (absolute lymphocyte count \<200 cells/microliter, 0.20 x 10\^3/microliter). 8. Received five or more doses of remdesivir including the loading dose, outside of the study as treatment for COVID-19. 9. Pregnancy or breast feeding (lactating women who agree to discard breast milk from Day 1 until two weeks after the last study product is given are not excluded). 10. Allergy to any study medication. 11. Received convalescent plasma or intravenous immunoglobulin \[IVIg\] for COVID-19, the current illness for which they are being enrolled. 12. Received any of the following in the two weeks prior to screening as treatment of COVID-19: * More than one dose of baricitinib for the treatment of COVID-19; * Other small molecule tyrosine kinase inhibitors (e.g. imatinib, gefitinib, acalabrutinib, etc.); * monoclonal antibodies targeting cytokines (e.g., TNF inhibitors, anti-interleukin-1 \[IL-1\], anti-IL-6 \[tocilizumab or sarilumab\], etc.); * monoclonal antibodies targeting T-cells or B-cells as treatment for COVID-19. Note: receipt of anti-SARS-CoV-2 monoclonal antibody (mAb) prior to enrollment (e.g. bamlanivimab) for their current COVID-19 illness is not exclusionary 13. Use of probenecid that cannot be discontinued at study enrollment. 14. Received 6 mg or more of dexamethasone by mouth (po) or Intravenous (IV) (or equivalent for other glucocorticoids) in one day, on more than one day, in the 7 days prior to time of randomization. Note: 6 mg dexamethasone dose equivalents include 40 mg prednisone, 32 mg methylprednisolone and 160 mg hydrocortisone. 15. Received \> / = 20 mg/day of prednisone po or IV (or equivalent for other glucocorticoids) for \> / = 14 consecutive days in the 4 weeks prior to screening. 16. Have diagnosis of current active or latent tuberculosis (TB), if known, treated for less than 4 weeks with appropriate therapy (by history only, no screening required). 17. Serious infection (besides COVID-19), immunosuppressive state, or immunosuppressive medications that in the opinion of the investigator could constitute a risk when taking baricitinib or dexamethasone. 18. Have received any live vaccine (that is, live attenuated) within 4 weeks before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note: Use of non-live (inactivated) vaccinations including SARS-CoV-2 vaccine is allowed for all subjects. 19. Had a known Venous thromboembolism (VTE)(deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\]) during the current COVID-19 illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) | Day 1 through Day 29 | Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates. |
| The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race | Day 1 through Day 29 | Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates. |
| The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Ethnicity | Day 1 through Day 29 | Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates. |
| The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Sex | Day 1 through Day 29 | Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Alanine Aminotransferase (ALT) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Aspartate Aminotransferase (AST) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in C-reactive Protein (CRP) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Creatinine | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in D-dimer Concentration | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Glucose | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Hemoglobin | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Platelets | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Prothrombin International Normalized Ratio (INR) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate INR was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Total Bilirubin | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in White Blood Cell Count (WBC) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Neutrophils | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Lymphocytes | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Monocytes | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Basophils | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Change From Baseline in Eosinophils | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | Day 1 through Day 29 | Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening. |
| Percentage of Participants Reporting Serious Adverse Events (SAEs) | Day 1 through Day 29 | An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. |
| Days of Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) | Day 1 through Day 29 | Duration of invasive ventilation/ECMO was measured in days among participants who required invasive ventilation, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die. |
| Days of Non-invasive Ventilation/High Flow Oxygen | Day 1 through Day 29 | Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die. |
| Duration of Supplemental Oxygen Use | Day 1 through Day 29 | Duration of supplemental oxygen use was measured in days among participants who were on oxygen at baseline, calculated in two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die. |
| Desirability of Outcome Ranking (DOOR) at Day 15 | Day 1 through Day 15 | Desirability of Outcome Ranking (DOOR) based on ordinal scale: 1) Recovered (category 1, 2 or 3 on ordinal scale); 2) Improved (\> / = 1 category improvement of ordinal scale compared with baseline) & no serious adverse event (SAE); 3) Improved (\> / = 1 category improvement of the ordinal scale compared with baseline) & SAE (related or unrelated); 4) No change in ordinal scale from baseline & no SAE; 5) No change in ordinal scale from baseline & SAE (related or unrelated); 6) Worsening (\> / = 1 category worse in ordinal scale from baseline); 7) Death. |
| Desirability of Outcome Ranking (DOOR) at Day 29 | Day 1 through Day 29 | Desirability of Outcome Ranking (DOOR) based on ordinal scale: 1) Recovered (category 1, 2 or 3 on ordinal scale); 2) Improved (\> / = 1 category improvement of ordinal scale compared with baseline) & no serious adverse event (SAE); 3) Improved (\> / = 1 category improvement of the ordinal scale compared with baseline) & SAE (related or unrelated); 4) No change in ordinal scale from baseline & no SAE; 5) No change in ordinal scale from baseline & SAE (related or unrelated); 6) Worsening (\> / = 1 category worse in ordinal scale from baseline); 7) Death. |
| Duration of Hospitalization | Day 1 through Day 29 | Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die. |
| Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Day 1 through Day 10 | Discontinuation or temporary suspension of study product administration, including participants who died or were discharged, was evaluated for each study product/placebo. |
| 14-day Participant Mortality | Day 1 through Day 15 | The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates. |
| 28-day Participant Mortality | Day 1 through Day 29 | The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates. |
| Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | Day 1 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. |
| Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | Day 3 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. |
| Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | Day 5 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. |
| Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | Day 8 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. |
| Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | Day 11 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. |
| Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | Day 15 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. |
| Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | Day 22 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. |
| Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | Day 29 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. |
| Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | Day 15 | The ordinal scale categories are defined as: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. |
| The Proportion of Participants Not Meeting Criteria for One of the Three Most Severe Ordinal Scale Categories at Any Time. | Day 1 through Day 29 | The three most severe ordinal scale categories are: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices. |
| Time to an Improvement of One Category From Baseline Using an Ordinal Scale | Day 1 through Day 29 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. Time to improvement by at least one category was determined for each participant. |
| Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale | Day 1 through Day 29 | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. Time to improvement by at least two categories was determined for each participant. |
| Time to Recovery | Day 1 through Day 29 | Day of recovery is defined as the first day on which the participant satisfies one of the following three ordinal scale categories: 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. |
Countries
Japan, Mexico, Singapore, South Korea, United States
Participant flow
Recruitment details
Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between December 2, 2020 and April 13, 2021.
Participants by arm
| Arm | Count |
|---|---|
| Remdesivir Plus Baricitinib 200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course. | 516 |
| Remdesivir Plus Dexamethasone 200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course. | 494 |
| Total | 1,010 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Enrolled but not treated | 12 | 12 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 7 |
Baseline characteristics
| Characteristic | Remdesivir Plus Baricitinib | Remdesivir Plus Dexamethasone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 171 Participants | 164 Participants | 335 Participants |
| Age, Categorical Between 18 and 65 years | 345 Participants | 330 Participants | 675 Participants |
| Age, Continuous | 58.2 years STANDARD_DEVIATION 14.3 | 58.5 years STANDARD_DEVIATION 13.7 | 58.3 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 188 Participants | 159 Participants | 347 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 318 Participants | 318 Participants | 636 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 17 Participants | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 10 Participants | 18 Participants |
| Race (NIH/OMB) Asian | 35 Participants | 35 Participants | 70 Participants |
| Race (NIH/OMB) Black or African American | 94 Participants | 94 Participants | 188 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 68 Participants | 68 Participants | 136 Participants |
| Race (NIH/OMB) White | 307 Participants | 281 Participants | 588 Participants |
| Region of Enrollment Japan | 0 participants | 3 participants | 3 participants |
| Region of Enrollment Mexico | 27 participants | 25 participants | 52 participants |
| Region of Enrollment Singapore | 2 participants | 2 participants | 4 participants |
| Region of Enrollment South Korea | 13 participants | 11 participants | 24 participants |
| Region of Enrollment United States | 474 participants | 453 participants | 927 participants |
| Sex: Female, Male Female | 216 Participants | 204 Participants | 420 Participants |
| Sex: Female, Male Male | 300 Participants | 290 Participants | 590 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 28 / 516 | 34 / 494 |
| other Total, other adverse events | 16 / 503 | 34 / 482 |
| serious Total, serious adverse events | 95 / 503 | 94 / 482 |
Outcome results
Primary
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)
Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment. One participant was excluded from mITT analyses due to a baseline ordinal score of 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Baricitinib | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) | 0.87 Proportion of participants |
| Remdesivir Plus Dexamethasone | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) | 0.88 Proportion of participants |
p-value: 0.909Chi-squared
Primary
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Ethnicity
Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized and for whom ethnicity was reported. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment. One participant was excluded from mITT analyses due to a baseline ordinal score of 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Ethnicity | Not Hispanic or Latino | 0.87 Proportion of participants |
| Remdesivir Plus Baricitinib | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Ethnicity | Hispanic or Latino | 0.88 Proportion of participants |
| Remdesivir Plus Dexamethasone | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Ethnicity | Not Hispanic or Latino | 0.87 Proportion of participants |
| Remdesivir Plus Dexamethasone | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Ethnicity | Hispanic or Latino | 0.87 Proportion of participants |
Primary
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race
Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment. One participant was excluded from mITT analyses due to a baseline ordinal score of 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race | Asian | 0.76 Proportion of participants |
| Remdesivir Plus Baricitinib | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race | Black or African American | 0.91 Proportion of participants |
| Remdesivir Plus Baricitinib | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race | White | 0.87 Proportion of participants |
| Remdesivir Plus Baricitinib | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race | Other | 0.87 Proportion of participants |
| Remdesivir Plus Dexamethasone | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race | Other | 0.89 Proportion of participants |
| Remdesivir Plus Dexamethasone | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race | Asian | 0.88 Proportion of participants |
| Remdesivir Plus Dexamethasone | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race | White | 0.88 Proportion of participants |
| Remdesivir Plus Dexamethasone | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race | Black or African American | 0.86 Proportion of participants |
Primary
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Sex
Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment. One participant was excluded from mITT analyses due to a baseline ordinal score of 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Sex | Male | 0.86 Proportion of participants |
| Remdesivir Plus Baricitinib | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Sex | Female | 0.89 Proportion of participants |
| Remdesivir Plus Dexamethasone | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Sex | Male | 0.87 Proportion of participants |
| Remdesivir Plus Dexamethasone | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Sex | Female | 0.88 Proportion of participants |
Secondary
14-day Participant Mortality
The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates.
Time frame: Day 1 through Day 15
Population: The mITT population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Baricitinib | 14-day Participant Mortality | 0.03 Proportion of participants |
| Remdesivir Plus Dexamethasone | 14-day Participant Mortality | 0.02 Proportion of participants |
Secondary
28-day Participant Mortality
The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.
Time frame: Day 1 through Day 29
Population: The mITT population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Baricitinib | 28-day Participant Mortality | 0.05 Proportion of participants |
| Remdesivir Plus Dexamethasone | 28-day Participant Mortality | 0.06 Proportion of participants |
Secondary
Change From Baseline in Alanine Aminotransferase (ALT)
Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Alanine Aminotransferase (ALT) | Day 3 | 1.1 Units/Liter (U/L) |
| Remdesivir Plus Baricitinib | Change From Baseline in Alanine Aminotransferase (ALT) | Day 5 | 6.0 Units/Liter (U/L) |
| Remdesivir Plus Baricitinib | Change From Baseline in Alanine Aminotransferase (ALT) | Day 8 | 4.7 Units/Liter (U/L) |
| Remdesivir Plus Baricitinib | Change From Baseline in Alanine Aminotransferase (ALT) | Day 11 | 5.6 Units/Liter (U/L) |
| Remdesivir Plus Baricitinib | Change From Baseline in Alanine Aminotransferase (ALT) | Day 15 | 7.1 Units/Liter (U/L) |
| Remdesivir Plus Baricitinib | Change From Baseline in Alanine Aminotransferase (ALT) | Day 29 | -3.8 Units/Liter (U/L) |
| Remdesivir Plus Dexamethasone | Change From Baseline in Alanine Aminotransferase (ALT) | Day 15 | 8.2 Units/Liter (U/L) |
| Remdesivir Plus Dexamethasone | Change From Baseline in Alanine Aminotransferase (ALT) | Day 3 | 4.3 Units/Liter (U/L) |
| Remdesivir Plus Dexamethasone | Change From Baseline in Alanine Aminotransferase (ALT) | Day 11 | 15.5 Units/Liter (U/L) |
| Remdesivir Plus Dexamethasone | Change From Baseline in Alanine Aminotransferase (ALT) | Day 5 | 15.9 Units/Liter (U/L) |
| Remdesivir Plus Dexamethasone | Change From Baseline in Alanine Aminotransferase (ALT) | Day 29 | 1.1 Units/Liter (U/L) |
| Remdesivir Plus Dexamethasone | Change From Baseline in Alanine Aminotransferase (ALT) | Day 8 | 16.1 Units/Liter (U/L) |
Secondary
Change From Baseline in Aspartate Aminotransferase (AST)
Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Aspartate Aminotransferase (AST) | Day 3 | -5.9 U/L |
| Remdesivir Plus Baricitinib | Change From Baseline in Aspartate Aminotransferase (AST) | Day 5 | -4.0 U/L |
| Remdesivir Plus Baricitinib | Change From Baseline in Aspartate Aminotransferase (AST) | Day 8 | -10.8 U/L |
| Remdesivir Plus Baricitinib | Change From Baseline in Aspartate Aminotransferase (AST) | Day 11 | -12.1 U/L |
| Remdesivir Plus Baricitinib | Change From Baseline in Aspartate Aminotransferase (AST) | Day 15 | -13.4 U/L |
| Remdesivir Plus Baricitinib | Change From Baseline in Aspartate Aminotransferase (AST) | Day 29 | -18.6 U/L |
| Remdesivir Plus Dexamethasone | Change From Baseline in Aspartate Aminotransferase (AST) | Day 15 | -15.4 U/L |
| Remdesivir Plus Dexamethasone | Change From Baseline in Aspartate Aminotransferase (AST) | Day 3 | -7.2 U/L |
| Remdesivir Plus Dexamethasone | Change From Baseline in Aspartate Aminotransferase (AST) | Day 11 | -16.4 U/L |
| Remdesivir Plus Dexamethasone | Change From Baseline in Aspartate Aminotransferase (AST) | Day 5 | -8.5 U/L |
| Remdesivir Plus Dexamethasone | Change From Baseline in Aspartate Aminotransferase (AST) | Day 29 | 9.9 U/L |
| Remdesivir Plus Dexamethasone | Change From Baseline in Aspartate Aminotransferase (AST) | Day 8 | -12.0 U/L |
Secondary
Change From Baseline in Basophils
Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Basophils | Day 3 | 0.008 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Basophils | Day 5 | 0.016 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Basophils | Day 8 | 0.015 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Basophils | Day 11 | 0.021 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Basophils | Day 15 | 0.035 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Basophils | Day 29 | 0.043 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Basophils | Day 15 | 0.030 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Basophils | Day 3 | 0.000 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Basophils | Day 11 | 0.006 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Basophils | Day 5 | 0.004 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Basophils | Day 29 | 0.046 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Basophils | Day 8 | 0.006 10^9 cells/liter |
Secondary
Change From Baseline in C-reactive Protein (CRP)
Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed. If a participant died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, the earliest post-treatment dose was used. Participants from sites reporting high sensitivity CRP were excluded.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in C-reactive Protein (CRP) | Day 3 | -41.1 milligrams/liter (mg/L) |
| Remdesivir Plus Baricitinib | Change From Baseline in C-reactive Protein (CRP) | Day 5 | -39.4 milligrams/liter (mg/L) |
| Remdesivir Plus Baricitinib | Change From Baseline in C-reactive Protein (CRP) | Day 8 | -53.0 milligrams/liter (mg/L) |
| Remdesivir Plus Baricitinib | Change From Baseline in C-reactive Protein (CRP) | Day 11 | -61.6 milligrams/liter (mg/L) |
| Remdesivir Plus Baricitinib | Change From Baseline in C-reactive Protein (CRP) | Day 15 | -73.2 milligrams/liter (mg/L) |
| Remdesivir Plus Baricitinib | Change From Baseline in C-reactive Protein (CRP) | Day 29 | -78.6 milligrams/liter (mg/L) |
| Remdesivir Plus Dexamethasone | Change From Baseline in C-reactive Protein (CRP) | Day 15 | -81.1 milligrams/liter (mg/L) |
| Remdesivir Plus Dexamethasone | Change From Baseline in C-reactive Protein (CRP) | Day 3 | -61.0 milligrams/liter (mg/L) |
| Remdesivir Plus Dexamethasone | Change From Baseline in C-reactive Protein (CRP) | Day 11 | -81.6 milligrams/liter (mg/L) |
| Remdesivir Plus Dexamethasone | Change From Baseline in C-reactive Protein (CRP) | Day 5 | -73.6 milligrams/liter (mg/L) |
| Remdesivir Plus Dexamethasone | Change From Baseline in C-reactive Protein (CRP) | Day 29 | -84.1 milligrams/liter (mg/L) |
| Remdesivir Plus Dexamethasone | Change From Baseline in C-reactive Protein (CRP) | Day 8 | -79.0 milligrams/liter (mg/L) |
Secondary
Change From Baseline in Creatinine
Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Creatinine | Day 3 | -0.207 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Creatinine | Day 5 | -0.287 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Creatinine | Day 8 | -0.434 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Creatinine | Day 11 | 0.007 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Creatinine | Day 15 | -0.011 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Creatinine | Day 29 | -0.064 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Creatinine | Day 15 | -0.024 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Creatinine | Day 3 | -0.081 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Creatinine | Day 11 | -0.102 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Creatinine | Day 5 | -0.122 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Creatinine | Day 29 | -0.029 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Creatinine | Day 8 | -0.096 mg/dL |
Secondary
Change From Baseline in D-dimer Concentration
Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For any missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed for all missing visits between them. If a participant died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, another pre-treatment dose was used, or the earliest post-treatment dose was used.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in D-dimer Concentration | Day 3 | 0.8 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Baricitinib | Change From Baseline in D-dimer Concentration | Day 5 | 0.7 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Baricitinib | Change From Baseline in D-dimer Concentration | Day 8 | 0.7 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Baricitinib | Change From Baseline in D-dimer Concentration | Day 11 | 0.7 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Baricitinib | Change From Baseline in D-dimer Concentration | Day 15 | 0.1 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Baricitinib | Change From Baseline in D-dimer Concentration | Day 29 | 0.1 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Dexamethasone | Change From Baseline in D-dimer Concentration | Day 15 | 0.3 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Dexamethasone | Change From Baseline in D-dimer Concentration | Day 3 | 0.2 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Dexamethasone | Change From Baseline in D-dimer Concentration | Day 11 | 0.5 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Dexamethasone | Change From Baseline in D-dimer Concentration | Day 5 | 0.7 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Dexamethasone | Change From Baseline in D-dimer Concentration | Day 29 | 0.2 mg/L fibrinogen-equivalent units (FEU) |
| Remdesivir Plus Dexamethasone | Change From Baseline in D-dimer Concentration | Day 8 | 0.9 mg/L fibrinogen-equivalent units (FEU) |
Secondary
Change From Baseline in Eosinophils
Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Eosinophils | Day 3 | 0.034 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Eosinophils | Day 5 | 0.104 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Eosinophils | Day 8 | 0.115 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Eosinophils | Day 11 | 0.116 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Eosinophils | Day 15 | 0.124 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Eosinophils | Day 29 | 0.208 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Eosinophils | Day 15 | 0.119 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Eosinophils | Day 3 | -0.006 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Eosinophils | Day 11 | 0.034 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Eosinophils | Day 5 | 0.006 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Eosinophils | Day 29 | 0.211 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Eosinophils | Day 8 | 0.027 10^9 cells/liter |
Secondary
Change From Baseline in Glucose
Blood to evaluate glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Glucose | Day 3 | -46.9 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Glucose | Day 5 | -43.2 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Glucose | Day 8 | -35.0 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Glucose | Day 11 | -28.1 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Glucose | Day 15 | -26.0 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Glucose | Day 29 | -28.9 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Glucose | Day 15 | -20.2 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Glucose | Day 3 | 3.8 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Glucose | Day 11 | -15.0 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Glucose | Day 5 | -6.7 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Glucose | Day 29 | -25.4 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Glucose | Day 8 | -9.6 mg/dL |
Secondary
Change From Baseline in Hemoglobin
Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Hemoglobin | Day 3 | -0.51 grams/deciliter (g/dL) |
| Remdesivir Plus Baricitinib | Change From Baseline in Hemoglobin | Day 5 | -0.64 grams/deciliter (g/dL) |
| Remdesivir Plus Baricitinib | Change From Baseline in Hemoglobin | Day 8 | -1.08 grams/deciliter (g/dL) |
| Remdesivir Plus Baricitinib | Change From Baseline in Hemoglobin | Day 11 | -1.44 grams/deciliter (g/dL) |
| Remdesivir Plus Baricitinib | Change From Baseline in Hemoglobin | Day 15 | -0.97 grams/deciliter (g/dL) |
| Remdesivir Plus Baricitinib | Change From Baseline in Hemoglobin | Day 29 | -0.51 grams/deciliter (g/dL) |
| Remdesivir Plus Dexamethasone | Change From Baseline in Hemoglobin | Day 15 | -0.91 grams/deciliter (g/dL) |
| Remdesivir Plus Dexamethasone | Change From Baseline in Hemoglobin | Day 3 | -0.25 grams/deciliter (g/dL) |
| Remdesivir Plus Dexamethasone | Change From Baseline in Hemoglobin | Day 11 | -0.76 grams/deciliter (g/dL) |
| Remdesivir Plus Dexamethasone | Change From Baseline in Hemoglobin | Day 5 | -0.13 grams/deciliter (g/dL) |
| Remdesivir Plus Dexamethasone | Change From Baseline in Hemoglobin | Day 29 | -0.66 grams/deciliter (g/dL) |
| Remdesivir Plus Dexamethasone | Change From Baseline in Hemoglobin | Day 8 | -0.15 grams/deciliter (g/dL) |
Secondary
Change From Baseline in Lymphocytes
Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Lymphocytes | Day 3 | 0.766 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Lymphocytes | Day 5 | 0.627 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Lymphocytes | Day 8 | 0.614 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Lymphocytes | Day 11 | 0.594 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Lymphocytes | Day 15 | 0.693 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Lymphocytes | Day 29 | 0.842 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Lymphocytes | Day 15 | 0.621 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Lymphocytes | Day 3 | 0.142 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Lymphocytes | Day 11 | 0.372 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Lymphocytes | Day 5 | 0.356 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Lymphocytes | Day 29 | 0.996 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Lymphocytes | Day 8 | 0.317 10^9 cells/liter |
Secondary
Change From Baseline in Monocytes
Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Monocytes | Day 3 | 0.114 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Monocytes | Day 5 | 0.164 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Monocytes | Day 8 | 0.257 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Monocytes | Day 11 | 0.367 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Monocytes | Day 15 | 0.295 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Monocytes | Day 29 | 0.171 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Monocytes | Day 15 | 0.286 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Monocytes | Day 3 | 0.120 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Monocytes | Day 11 | 0.306 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Monocytes | Day 5 | 0.180 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Monocytes | Day 29 | 0.159 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Monocytes | Day 8 | 0.221 10^9 cells/liter |
Secondary
Change From Baseline in Neutrophils
Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Neutrophils | Day 3 | -0.500 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Neutrophils | Day 5 | 0.356 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Neutrophils | Day 8 | 1.421 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Neutrophils | Day 11 | 2.937 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Neutrophils | Day 15 | 0.416 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Neutrophils | Day 29 | -0.659 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Neutrophils | Day 15 | 1.229 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Neutrophils | Day 3 | 0.974 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Neutrophils | Day 11 | 4.135 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Neutrophils | Day 5 | 1.407 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Neutrophils | Day 29 | -1.239 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Neutrophils | Day 8 | 3.227 10^9 cells/liter |
Secondary
Change From Baseline in Platelets
Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Platelets | Day 3 | 53.1 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Platelets | Day 5 | 107.4 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Platelets | Day 8 | 178.9 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Platelets | Day 11 | 193.9 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Platelets | Day 15 | 139.6 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in Platelets | Day 29 | 35.3 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Platelets | Day 15 | 45.3 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Platelets | Day 3 | 70.4 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Platelets | Day 11 | 105.0 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Platelets | Day 5 | 117.6 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Platelets | Day 29 | 69.4 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in Platelets | Day 8 | 140.4 10^9 cells/liter |
Secondary
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Blood to evaluate INR was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 3 | 0.06 ratio |
| Remdesivir Plus Baricitinib | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 5 | 0.11 ratio |
| Remdesivir Plus Baricitinib | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 8 | 0.11 ratio |
| Remdesivir Plus Baricitinib | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 11 | 0.09 ratio |
| Remdesivir Plus Baricitinib | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 15 | 0.00 ratio |
| Remdesivir Plus Baricitinib | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 29 | -0.06 ratio |
| Remdesivir Plus Dexamethasone | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 15 | -0.04 ratio |
| Remdesivir Plus Dexamethasone | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 3 | -0.01 ratio |
| Remdesivir Plus Dexamethasone | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 11 | -0.14 ratio |
| Remdesivir Plus Dexamethasone | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 5 | -0.03 ratio |
| Remdesivir Plus Dexamethasone | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 29 | -0.05 ratio |
| Remdesivir Plus Dexamethasone | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Day 8 | -0.08 ratio |
Secondary
Change From Baseline in Total Bilirubin
Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in Total Bilirubin | Day 3 | 0.00 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Total Bilirubin | Day 5 | 0.06 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Total Bilirubin | Day 8 | 0.03 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Total Bilirubin | Day 11 | 0.04 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Total Bilirubin | Day 15 | -0.01 mg/dL |
| Remdesivir Plus Baricitinib | Change From Baseline in Total Bilirubin | Day 29 | -0.02 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Total Bilirubin | Day 15 | 0.03 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Total Bilirubin | Day 3 | -0.09 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Total Bilirubin | Day 11 | 0.05 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Total Bilirubin | Day 5 | -0.03 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Total Bilirubin | Day 29 | -0.05 mg/dL |
| Remdesivir Plus Dexamethasone | Change From Baseline in Total Bilirubin | Day 8 | 0.03 mg/dL |
Secondary
Change From Baseline in White Blood Cell Count (WBC)
Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time frame: Days 1, 3, 5, 8, 11, 15 and 29
Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Change From Baseline in White Blood Cell Count (WBC) | Day 11 | 4.153 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in White Blood Cell Count (WBC) | Day 8 | 2.629 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in White Blood Cell Count (WBC) | Day 15 | 1.638 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in White Blood Cell Count (WBC) | Day 5 | 1.358 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in White Blood Cell Count (WBC) | Day 29 | 0.688 10^9 cells/liter |
| Remdesivir Plus Baricitinib | Change From Baseline in White Blood Cell Count (WBC) | Day 3 | 0.433 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in White Blood Cell Count (WBC) | Day 29 | 0.116 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in White Blood Cell Count (WBC) | Day 3 | 1.292 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in White Blood Cell Count (WBC) | Day 8 | 4.048 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in White Blood Cell Count (WBC) | Day 11 | 5.179 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in White Blood Cell Count (WBC) | Day 15 | 2.386 10^9 cells/liter |
| Remdesivir Plus Dexamethasone | Change From Baseline in White Blood Cell Count (WBC) | Day 5 | 2.072 10^9 cells/liter |
Secondary
Days of Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO)
Duration of invasive ventilation/ECMO was measured in days among participants who required invasive ventilation, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Time frame: Day 1 through Day 29
Population: The analysis population is restricted to randomized participants who were on invasive ventilation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Days of Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) | Including imputations for participants who died | 27 Days |
| Remdesivir Plus Baricitinib | Days of Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) | Among participants who did not die | 14 Days |
| Remdesivir Plus Dexamethasone | Days of Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) | Including imputations for participants who died | 28 Days |
| Remdesivir Plus Dexamethasone | Days of Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) | Among participants who did not die | 15 Days |
Secondary
Days of Non-invasive Ventilation/High Flow Oxygen
Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Time frame: Day 1 through Day 29
Population: The analysis population is restricted to randomized participants who were not on noninvasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Days of Non-invasive Ventilation/High Flow Oxygen | Including imputations for participants who died | 5 Days |
| Remdesivir Plus Baricitinib | Days of Non-invasive Ventilation/High Flow Oxygen | Among participants who did not die | 4 Days |
| Remdesivir Plus Dexamethasone | Days of Non-invasive Ventilation/High Flow Oxygen | Including imputations for participants who died | 8 Days |
| Remdesivir Plus Dexamethasone | Days of Non-invasive Ventilation/High Flow Oxygen | Among participants who did not die | 6 Days |
Secondary
Desirability of Outcome Ranking (DOOR) at Day 15
Desirability of Outcome Ranking (DOOR) based on ordinal scale: 1) Recovered (category 1, 2 or 3 on ordinal scale); 2) Improved (\> / = 1 category improvement of ordinal scale compared with baseline) & no serious adverse event (SAE); 3) Improved (\> / = 1 category improvement of the ordinal scale compared with baseline) & SAE (related or unrelated); 4) No change in ordinal scale from baseline & no SAE; 5) No change in ordinal scale from baseline & SAE (related or unrelated); 6) Worsening (\> / = 1 category worse in ordinal scale from baseline); 7) Death.
Time frame: Day 1 through Day 15
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 15 | 3 - Improved (=1 category improvement compared with baseline) & SAE (related or unrelated) | 1 percentage of participants |
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 15 | 5 - No change in Clinical Status from baseline & SAE (related or unrelated) | 3 percentage of participants |
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 15 | 2 - Improved (=1 category improvement in Clinical Status compared with baseline) & no SAE | 3 percentage of participants |
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 15 | 6 - Worsening (=1 category worse in Clinical Status compared with baseline) | 7 percentage of participants |
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 15 | 4 - No change in Clinical Status from baseline & no SAE | 7 percentage of participants |
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 15 | 7 - Death | 3 percentage of participants |
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 15 | 1 - Recovered (Category 1, 2 or 3 Clinical Status) | 76 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 15 | 7 - Death | 3 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 15 | 1 - Recovered (Category 1, 2 or 3 Clinical Status) | 77 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 15 | 2 - Improved (=1 category improvement in Clinical Status compared with baseline) & no SAE | 1 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 15 | 3 - Improved (=1 category improvement compared with baseline) & SAE (related or unrelated) | 2 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 15 | 4 - No change in Clinical Status from baseline & no SAE | 6 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 15 | 5 - No change in Clinical Status from baseline & SAE (related or unrelated) | 2 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 15 | 6 - Worsening (=1 category worse in Clinical Status compared with baseline) | 10 percentage of participants |
Secondary
Desirability of Outcome Ranking (DOOR) at Day 29
Desirability of Outcome Ranking (DOOR) based on ordinal scale: 1) Recovered (category 1, 2 or 3 on ordinal scale); 2) Improved (\> / = 1 category improvement of ordinal scale compared with baseline) & no serious adverse event (SAE); 3) Improved (\> / = 1 category improvement of the ordinal scale compared with baseline) & SAE (related or unrelated); 4) No change in ordinal scale from baseline & no SAE; 5) No change in ordinal scale from baseline & SAE (related or unrelated); 6) Worsening (\> / = 1 category worse in ordinal scale from baseline); 7) Death.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 29 | 3 - Improved (=1 category improvement compared with baseline) & SAE (related or unrelated) | 1 percentage of participants |
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 29 | 5 - No change in Clinical Status from baseline & SAE (related or unrelated) | 1 percentage of participants |
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 29 | 2 - Improved (=1 category improvement in Clinical Status compared with baseline) & no SAE | 0.002 percentage of participants |
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 29 | 6 - Worsening (=1 category worse in Clinical Status compared with baseline) | 3 percentage of participants |
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 29 | 4 - No change in Clinical Status from baseline & no SAE | 3 percentage of participants |
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 29 | 7 - Death | 5 percentage of participants |
| Remdesivir Plus Baricitinib | Desirability of Outcome Ranking (DOOR) at Day 29 | 1 - Recovered (Category 1, 2 or 3 Clinical Status) | 85 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 29 | 7 - Death | 7 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 29 | 1 - Recovered (Category 1, 2 or 3 Clinical Status) | 84 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 29 | 2 - Improved (=1 category improvement in Clinical Status compared with baseline) & no SAE | 0.002 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 29 | 3 - Improved (=1 category improvement compared with baseline) & SAE (related or unrelated) | 1 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 29 | 4 - No change in Clinical Status from baseline & no SAE | 3 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 29 | 5 - No change in Clinical Status from baseline & SAE (related or unrelated) | 1 percentage of participants |
| Remdesivir Plus Dexamethasone | Desirability of Outcome Ranking (DOOR) at Day 29 | 6 - Worsening (=1 category worse in Clinical Status compared with baseline) | 4 percentage of participants |
Secondary
Duration of Hospitalization
Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Time frame: Day 1 through Day 29
Population: The modified intent-to-treat (ITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Duration of Hospitalization | Including imputations for participants who died | 7 Days |
| Remdesivir Plus Baricitinib | Duration of Hospitalization | Among participants who did not die | 6 Days |
| Remdesivir Plus Dexamethasone | Duration of Hospitalization | Including imputations for participants who died | 6 Days |
| Remdesivir Plus Dexamethasone | Duration of Hospitalization | Among participants who did not die | 6 Days |
Secondary
Duration of Supplemental Oxygen Use
Duration of supplemental oxygen use was measured in days among participants who were on oxygen at baseline, calculated in two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Time frame: Day 1 through Day 29
Population: The analysis population is restricted to randomized participants who were on oxygen at baseline.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Duration of Supplemental Oxygen Use | Including imputations for participants who died | 10 Days |
| Remdesivir Plus Baricitinib | Duration of Supplemental Oxygen Use | Among participants who did not die | 9 Days |
| Remdesivir Plus Dexamethasone | Duration of Supplemental Oxygen Use | Including imputations for participants who died | 10.5 Days |
| Remdesivir Plus Dexamethasone | Duration of Supplemental Oxygen Use | Among participants who did not die | 8 Days |
Secondary
Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration
Discontinuation or temporary suspension of study product administration, including participants who died or were discharged, was evaluated for each study product/placebo.
Time frame: Day 1 through Day 10
Population: The mITT population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Remdesivir | 460 Participants |
| Remdesivir Plus Baricitinib | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Baricitinib/Placebo | 486 Participants |
| Remdesivir Plus Baricitinib | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Dexamethasone/placebo | 410 Participants |
| Remdesivir Plus Dexamethasone | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Remdesivir | 444 Participants |
| Remdesivir Plus Dexamethasone | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Baricitinib/Placebo | 452 Participants |
| Remdesivir Plus Dexamethasone | Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration | Dexamethasone/placebo | 387 Participants |
Secondary
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Time frame: Day 1
Population: The mITT population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 8) Death | 0.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 0.0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 16.1 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 5) Hospitalized, requiring supplemental oxygen | 83.7 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 0.0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0.0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 0.0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 1) Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 1) Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 8) Death | 0.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 0.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 0.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 0.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 14.2 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 | 5) Hospitalized, requiring supplemental oxygen | 85.8 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Time frame: Day 11
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 8) Death | 2.1 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 7.8 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 6.6 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 5) Hospitalized, requiring supplemental oxygen | 14.4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 2.7 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 1.4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 63.5 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 1) Not hospitalized, no limitations on activities | 1.6 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 1) Not hospitalized, no limitations on activities | 1.6 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 8) Death | 1.2 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 3.2 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 6.9 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 66.4 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 9.1 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0.4 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 | 5) Hospitalized, requiring supplemental oxygen | 11.1 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Time frame: Day 15
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 3.7 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 1.0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 6.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 51.5 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 5) Hospitalized, requiring supplemental oxygen | 9.3 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 1) Not hospitalized, no limitations on activities | 23.3 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 1.9 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 8) Death | 3.1 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 5) Hospitalized, requiring supplemental oxygen | 7.9 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 8) Death | 2.6 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 6.1 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 5.3 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 1.2 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0.4 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 53.6 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 | 1) Not hospitalized, no limitations on activities | 22.9 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Time frame: Day 22
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 8) Death | 4.9 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 4.3 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 2.1 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 5) Hospitalized, requiring supplemental oxygen | 5.4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 0.8 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0.0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 48.0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 1) Not hospitalized, no limitations on activities | 34.6 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 1) Not hospitalized, no limitations on activities | 33.6 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 8) Death | 4.9 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 0.2 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 4.9 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 48.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 2.8 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0.2 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 | 5) Hospitalized, requiring supplemental oxygen | 5.5 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Time frame: Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 8) Death | 5.4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 2.7 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 2.3 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 5) Hospitalized, requiring supplemental oxygen | 4.1 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 0.6 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0.0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 57.3 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 1) Not hospitalized, no limitations on activities | 27.6 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 1) Not hospitalized, no limitations on activities | 32.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 8) Death | 6.9 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 0.4 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 2.6 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 52.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 2.6 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 | 5) Hospitalized, requiring supplemental oxygen | 3.4 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Time frame: Day 3
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 8) Death | 0.4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 3.1 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 22.1 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 5) Hospitalized, requiring supplemental oxygen | 71.7 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 2.7 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0.0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 0.0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 1) Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 1) Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 8) Death | 0.4 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 3.2 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 1.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 0.4 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 21.5 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 | 5) Hospitalized, requiring supplemental oxygen | 73.5 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Time frame: Day 5
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 8) Death | 0.6 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 5.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 19.4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 9.5 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 1.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 10.7 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 1) Not hospitalized, no limitations on activities | 0.0 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 5) Hospitalized, requiring supplemental oxygen | 53.4 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 11.9 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 8) Death | 0.4 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 13.2 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 3.4 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0.6 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 20.9 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 5) Hospitalized, requiring supplemental oxygen | 49.2 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 | 1) Not hospitalized, no limitations on activities | 0.4 percentage of participants |
Secondary
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Time frame: Day 8
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 8) Death | 1.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 7.4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 12.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 6.4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 1.4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 46.4 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 1) Not hospitalized, no limitations on activities | 0.2 percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 5) Hospitalized, requiring supplemental oxygen | 24.9 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 5.7 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 8) Death | 0.8 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen | 47.0 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 6.1 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 1.4 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 14.6 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 5) Hospitalized, requiring supplemental oxygen | 24.5 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 | 1) Not hospitalized, no limitations on activities | 0.0 percentage of participants |
Secondary
Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories
The ordinal scale categories are defined as: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Time frame: Day 15
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 8) Death | 3 Percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 6 Percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 4 Percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 5) Hospitalized, requiring supplemental oxygen | 9 Percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 2 Percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 1 Percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 2) Not hospitalized, but has new or increased limitation on activities and/or new oxygen use | 51 Percentage of participants |
| Remdesivir Plus Baricitinib | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 1) Not hospitalized, no limitations on activities | 23 Percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 1) Not hospitalized, no limitations on activities | 23 Percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 8) Death | 3 Percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 1 Percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 7) Hospitalized, on invasive mechanical ventilation or ECMO | 6 Percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 2) Not hospitalized, but has new or increased limitation on activities and/or new oxygen use | 54 Percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices | 5 Percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0.4 Percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories | 5) Hospitalized, requiring supplemental oxygen | 8 Percentage of participants |
95% CI: [0.8, 1.27]
Secondary
Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)
Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Time frame: Day 1 through Day 29
Population: The safety population includes all participants with available data post baseline, analyzed as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | 28.4 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) | 36.1 percentage of participants |
95% CI: [1.8, 13.4]
Secondary
Percentage of Participants Reporting Serious Adverse Events (SAEs)
An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Time frame: Day 1 through Day 29
Population: The safety population includes all participants with available data post baseline, analyzed as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Baricitinib | Percentage of Participants Reporting Serious Adverse Events (SAEs) | 18.9 percentage of participants |
| Remdesivir Plus Dexamethasone | Percentage of Participants Reporting Serious Adverse Events (SAEs) | 19.5 percentage of participants |
95% CI: [-4.3, 5.5]
Secondary
The Proportion of Participants Not Meeting Criteria for One of the Three Most Severe Ordinal Scale Categories at Any Time.
The three most severe ordinal scale categories are: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remdesivir Plus Baricitinib | The Proportion of Participants Not Meeting Criteria for One of the Three Most Severe Ordinal Scale Categories at Any Time. | 0.81 Proportion of participants |
| Remdesivir Plus Dexamethasone | The Proportion of Participants Not Meeting Criteria for One of the Three Most Severe Ordinal Scale Categories at Any Time. | 0.78 Proportion of participants |
95% CI: [-0.09, 0.02]
Secondary
Time to an Improvement of One Category From Baseline Using an Ordinal Scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. Time to improvement by at least one category was determined for each participant.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir Plus Baricitinib | Time to an Improvement of One Category From Baseline Using an Ordinal Scale | 5.0 Days |
| Remdesivir Plus Dexamethasone | Time to an Improvement of One Category From Baseline Using an Ordinal Scale | 4.0 Days |
95% CI: [0.94, 1.23]
Secondary
Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. Time to improvement by at least two categories was determined for each participant.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir Plus Baricitinib | Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale | 6.0 Days |
| Remdesivir Plus Dexamethasone | Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale | 5.0 Days |
95% CI: [0.94, 1.23]
Secondary
Time to Recovery
Day of recovery is defined as the first day on which the participant satisfies one of the following three ordinal scale categories: 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Time frame: Day 1 through Day 29
Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remdesivir Plus Baricitinib | Time to Recovery | 6.0 Days |
| Remdesivir Plus Dexamethasone | Time to Recovery | 5.0 Days |
95% CI: [0.91, 1.19]