Novel Coronavirus Infectious Disease (COVID-19)
Conditions
Interventions
Dosing and Administration
All subjects will receive remdesivir as a 200 mg intravenous (IV) loading dose on Day 1, followed by a 100 mg once-daily IV maintenance dose for the duration of the hospitali
Sponsors
Ohmagari Norio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Admitted to a hospital with symptoms suggestive of COVID-19 infection. 2.Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3.Subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 4.Male or non-pregnant female adult =>18 years of age at time of enrollment. 5.Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen, as documented by either of the following -PCR positive in sample collected 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc.). AND progressive disease suggestive of ongoing SARS-CoV-2 infection. 6.Illness of any duration, and at least one of the following -Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR -SpO2 <= 94% on room air, OR -Requiring supplemental oxygen, OR -Requiring mechanical ventilation. 7.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. 8.Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29.
Exclusion criteria
Exclusion criteria: 1. ALT or AST > 5 times the upper limit of normal. 2. Estimated glomerular filtration rate (eGFR) 20 mg/day of prednisone or equivalent for =>14 consecutive days in the 4 weeks prior to screening. 15. Use of probenecid that cannot be discontinued at study enrollment. 16. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required). 17. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product. 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 is allowed for all subjects. 19. Have a history of VTE (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 12 weeks prior to screening or have a history of recurrent (>1) VTE (DVT/PE). 20. Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrollment, who, in the judgment of PI, are at increased risk for serious infections or other safety concerns given the study products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -The overall objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the control arm among hospitalized adults who have COVID-19. -To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm. -To evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the clinical efficacy of different investigational therapeutics as compared to the control arm as assessed by (1) Clinical Severity 1) Ordinal scale -Time to an improvement of one category and two categories from Day1(baseline) using an ordinal scale. -Subject clinical status using ordinal scale at Days 3, 5, 8, 11, 15, 22, and 29. -Mean change in the ordinal scale from Day 1 to Days 3, 5, 8, 11, 15, 22, and 29. 2)National Early Warning Score (NEWS) -Time to discharge or to a NEWS of <= 2 and maintained for 24 hours, whichever occurs first. -Change from Day 1 to Days 3, 5, 8, 11, 15, and 29 in NEWS. 3)Oxygenation -Oxygenation use up to Day 29. -Incidence and duration of new oxygen use during the study. 4)Non-invasive ventilation/high flow oxygen -Non-invasive ventilation/high flow oxygen use up to Day 29. -Incidence and duration of new non-invasive ventilation or high flow oxygen use during the study. 5)Invasive Mechanical Ventilation / extracorporeal membrane oxygenation (ECMO) -Ventilator / ECMO use up to Day 29. -Incidence and duration of new mechanical ventilation or ECMO use during the study.(2) Hospitalization 1)Duration of hospitalization(days) (3) Mortality 1)14-day mortality 2)28-day mortality 2. To evaluate the safety of different investigational therapeutics as compared to the control arm as assessed by (1) Cumulative incidence of SAEs through Day 29. (2) Cumulative incidence of Grade 3 and 4 clinical and/or laboratory AEs through Day 29. (3) Discontinuation or temporary suspension of study product administrations (for any reason) (4) Changes in white blood cell (WBC) count with differential, hemoglobin, platelets, creatinine, glucose, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and prothrombin time (PT) over time (analysis of lab values in addition to AEs noted above). | — |
Countries
Denmark, Japan, Korea, Mexico, Singapore, Spain, United Kingdom, United States
Contacts
Public ContactAyako Mikami
National Center for Global Health and Medicine
Outcome results
None listed