Covid19
Conditions
Keywords
COVID19
Brief summary
ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on other research findings. Comparisons of the agents among themselves is not a research objective. The study population corresponds to moderately and severely ill patients infected with the coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already hospitalized for treatment of COVID-19 infection as well as patients being treated for COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital. Patients both in and out of the ICU are included in the study population.
Detailed description
ACTIV-1 IM is a master protocol designed to evaluate immune modulators for the treatment of moderately or severely ill hospitalized patients infected with COVID-19. Trial participants will be assessed daily while hospitalized. If the participants are discharged from the hospital prior to Day 29, they will have follow-up study visits at Days 8, 11, 15, 22, and 29. For discharged participants, it is preferred that the Day 8, 11, 15, and 29 visits are in person to obtain safety laboratory tests and blood (serum/plasma) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the participant to return to the clinic. In this case, 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 Day 60 assessment will be conducted by phone. The effectiveness of each therapeutic agent as add-on therapy to SoC plus remdesivir (provided) will be evaluated based on the primary endpoint of time to recovery by Day 29. The sample size requirements are based on the ability to detect a moderate improvement in time to recovery (3-4 fewer days) for each agent. A total of 788 recoveries are required for each comparison to provide approximately 85% power to detect a recovery rate ratio of 1.25. Assuming 73% of participants achieve recovery in 28 days, consistent with the ACTT-1 results, the total sample size to evaluate 1, 2, and 3 agents in ACTIV-1 IM is approximately 1080, 1620, and 2160, respectively. Because each agent is being compared to SoC with no between-agent comparisons, no multiplicity adjustments for multiple agents are planned. The CVC arm of the study was closed to enrollment on 3-Sep-2021.
Interventions
DRUGInfliximab
study drug or matching placebo
DRUGAbatacept
study drug or matching placebo
DRUGRemdesivir
Standard of Care
DRUGcenicriviroc (closed to enrollment as of 3-Sep-2021)
study drug or matching placebo
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Biomedical Advanced Research and Development Authority
Daniel Benjamin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Study Drug and Matching Placebo
Intervention model description
ACTIV-1 IM builds upon findings and the model used for other network COVID studies. Including multiple therapeutic agents under a single protocol avoids duplication of effort in terms of infrastructure, trial governance, information systems (EDC, web-based randomization, etc.) and other aspects of study management. Implementation of the master protocol facilitates discontinuation of less promising agents and addition of possibly newly emergent agents that become available after the study begins, without stopping and starting the study itself for extended pauses. All test agents are evaluated as add-on therapies to the local SoC at each clinic. The master protocol design allows for the efficacy and safety of each agent to be determined based on comparisons with a pooled control group, consisting of patients receiving SoC plus placebo. Sharing control patients across all test agents substantially reduces the sample size requirements for the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Admitted to a hospital or awaiting admission in the ED with symptoms suggestive of COVID-19. 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 adults ≥18 years of age at time of enrollment. 5. Has laboratory-confirmed (within 14 days prior to enrollment) SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen. 6. Ongoing illness of any duration, and at least one of the following: * Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR * Blood oxygen saturation (SpO2) ≤94% on room air, OR * Requiring supplemental oxygen, OR * Requiring mechanical ventilation or ECMO. 7. Women of childbearing potential must agree to either abstinence or use of at least one primary form of contraception not including hormonal contraception from the time of screening through Day 60. 8. Agrees to not to participate in another interventional trial for the treatment of COVID-19 through Day 60. Exception 1: Participant may co-enroll in ACTIV-4 (ACTIV-4A and ACTIV-4C). Exception 2: Participants in ACTIV-2 who have been hospitalized may be enrolled in ACTIV-1 as long as ACTIV-2 study therapy has been discontinued. They will remain in ACTIV-2 follow-up. Exception 3: If participant is already participating in a COVID-19 vaccine trial but develops COVID-19 disease that requires hospitalization, participant is eligible for this study, assuming all other inclusion/
Exclusion criteria
are met.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Recovered by Day 28 | Days 1-28 | Time to recovery by day 28. The number of participants who have recovered by day 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Through 28 Days | Day 1-28 | mortality at day 28 |
| Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | Day 28 | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) To determine a participant's clinical status using the ordinal scale their clinical status was collected at Day 29 assessing day 28. The scale used in this study is as follows (from worst to best): 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical in-patient care; This would include those kept in hospital for quarantine/infection control/social reasons, awaiting bed in rehabilitation facility or homecare, etc. 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, |
| Mortality Through 14 Days | Day 1-14 | mortality at day 14 |
| Number of Participants Who Met a One Point Improvement in One Category From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | Day 1-day 28 | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best). Number of people who met a 1 point improvement. The scale used in this study is as follows (from worst to best): 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical in-patient care; This would include those kept in hospital for quarantine/infection control/social reasons, awaiting bed in rehabilitation facility or homecare, etc. 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities. |
| Number of Participants Who Met a One Point Improvement in Two Categories From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | Day 1- day 28 | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best). Number of people who met a two category improvement. The scale used in this study is as follows (from worst to best): 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical in-patient care; This would include those kept in hospital for quarantine/infection control/social reasons, awaiting bed in rehabilitation facility or homecare, etc. 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities. |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 2 | Day 0 to day 2 | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 4 | Day 0 to day 4 | 8 point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 7 | Day 0 to day 7 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities=best) |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 10 | Day 0 to day 10 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 14 | Day 0 to day 14 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 21 | Day 0 to day 21 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) |
| Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | Day 14 | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) To determine a participant's clinical status using the ordinal scale their clinical status was collected at Day 15 assessing day 14. The scale used in this study is as follows (from worst to best): 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical in-patient care; This would include those kept in hospital for quarantine/infection control/social reasons, awaiting bed in rehabilitation facility or homecare, etc. 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, |
| Duration (Days) Alive and Free of Supplemental Oxygen | Day 1 to day 28 | Days alive and free of supplemental oxygen |
| Number of Patients With New Supplemental Oxygen Use | Day 1-day 28 | Number of patients with new supplemental oxygen use |
| Duration (Days) Alive and Free of Non-invasive Ventilation/ High Flow Oxygen | Day 1 to day 28 | Days alive and free of non-invasive ventilation/ high flow oxygen |
| Number of Patients With New Non-invasive Ventilation/High Flow Oxygen Use | Day 1-day 28 | Number of patients with new non-invasive ventilation/high flow oxygen use |
| Duration (Days) Alive and Free of Invasive Mechanical Ventilation or ECMO | Day 1 to day 28 | Days alive and free of invasive mechanical ventilation or ECMO |
| Number of Patients With New Mechanical Ventilation or ECMO Use | Day 1 to day 28 | Number of patients with new mechanical ventilation or ECMO use |
| Duration (Days) Alive and Out of the Hospital | Through day 28 | Days alive and out of the hospital |
| Number of Patients With SAEs Through Day 28 | Day 28 | Cumulative Incidence of SAEs through day 28 |
| Number of Patients With Grade 3 and 4 Adverse Events | Day 28 | Cumulative incidence of adverse events of grade 3 and 4 |
| Number of Patients With Adverse Events Leading to Dose Modification | Day 1-28 | Number of patients with adverse events (serious and non serious) leading to dose modification |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 28 | Day 0 to day 28 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) |
Countries
Argentina, Brazil, Mexico, Peru, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care + Infliximab infliximab (single dose IV 5mg/kg given on day 1)
Infliximab: study drug
Remdesivir: Standard of Care | 531 |
| Standard of Care + Abatacept abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1)
Abatacept: study drug
Remdesivir: Standard of Care | 524 |
| Standard of Care + Cenicriviroc cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\].
Remdesivir: Standard of Care
cenicriviroc (closed to enrollment as of 3-Sep-2021): study drug | 360 |
| Shared Placebo placebo group
placebo group was shared among up to all 3 arms; whichever arms the participant qualified. | 556 |
| Total | 1,971 |
Baseline characteristics
| Characteristic | Shared Placebo | Total | Standard of Care + Infliximab | Standard of Care + Abatacept | Standard of Care + Cenicriviroc |
|---|---|---|---|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 14.66 | 54.8 years STANDARD_DEVIATION 14.64 | 54.7 years STANDARD_DEVIATION 14.87 | 54.8 years STANDARD_DEVIATION 14.65 | 54.7 years STANDARD_DEVIATION 14.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 270 Participants | 905 Participants | 257 Participants | 219 Participants | 159 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 275 Participants | 1009 Participants | 264 Participants | 283 Participants | 187 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 57 Participants | 10 Participants | 22 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 19 Participants | 5 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 56 Participants | 12 Participants | 16 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 76 Participants | 274 Participants | 80 Participants | 74 Participants | 44 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 105 Participants | 384 Participants | 103 Participants | 103 Participants | 73 Participants |
| Race (NIH/OMB) White | 350 Participants | 1229 Participants | 328 Participants | 325 Participants | 226 Participants |
| Region of Enrollment Argentina | 64 Participants | 205 Participants | 56 Participants | 52 Participants | 33 Participants |
| Region of Enrollment Brazil | 57 Participants | 195 Participants | 54 Participants | 46 Participants | 38 Participants |
| Region of Enrollment Mexico | 18 Participants | 59 Participants | 15 Participants | 18 Participants | 8 Participants |
| Region of Enrollment Peru | 63 Participants | 221 Participants | 62 Participants | 56 Participants | 40 Participants |
| Region of Enrollment United States | 354 Participants | 1291 Participants | 344 Participants | 352 Participants | 241 Participants |
| Sex: Female, Male Female | 235 Participants | 753 Participants | 198 Participants | 197 Participants | 123 Participants |
| Sex: Female, Male Male | 321 Participants | 1218 Participants | 333 Participants | 327 Participants | 237 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 65 / 531 | 85 / 530 | 74 / 524 | 87 / 525 | 64 / 360 | 49 / 363 |
| other Total, other adverse events | 18 / 517 | 18 / 516 | 24 / 509 | 18 / 510 | 13 / 355 | 13 / 354 |
| serious Total, serious adverse events | 125 / 517 | 130 / 516 | 128 / 509 | 136 / 510 | 102 / 355 | 84 / 354 |
Outcome results
Primary
Number of Participants Who Had Recovered by Day 28
Time to recovery by day 28. The number of participants who have recovered by day 28.
Time frame: Days 1-28
Population: Intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care + Infliximab | Number of Participants Who Had Recovered by Day 28 | 421 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants Who Had Recovered by Day 28 | 405 Participants |
| Standard of Care + Abatacept | Number of Participants Who Had Recovered by Day 28 | 414 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants Who Had Recovered by Day 28 | 397 Participants |
| Standard of Care + Cenicriviroc | Number of Participants Who Had Recovered by Day 28 | 273 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants Who Had Recovered by Day 28 | 287 Participants |
p-value: 0.079395% CI: [0.987, 1.275]Fine-Gray Proportional Hazards Model
p-value: 0.086495% CI: [0.984, 1.275]Fine-Gray Proportional Hazards Model
p-value: 0.935495% CI: [0.862, 1.176]Fine-Gray Proportional Hazards Model
Secondary
Duration (Days) Alive and Free of Invasive Mechanical Ventilation or ECMO
Days alive and free of invasive mechanical ventilation or ECMO
Time frame: Day 1 to day 28
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care + Infliximab | Duration (Days) Alive and Free of Invasive Mechanical Ventilation or ECMO | 23.4 days | Standard Deviation 8.96 |
| Standard of Care + Infliximab Matching Placebo | Duration (Days) Alive and Free of Invasive Mechanical Ventilation or ECMO | 22.6 days | Standard Deviation 9.75 |
| Standard of Care + Abatacept | Duration (Days) Alive and Free of Invasive Mechanical Ventilation or ECMO | 23.4 days | Standard Deviation 9.16 |
| Standard of Care + Abatacept Matching Placebo | Duration (Days) Alive and Free of Invasive Mechanical Ventilation or ECMO | 22.6 days | Standard Deviation 9.72 |
| Standard of Care + Cenicriviroc | Duration (Days) Alive and Free of Invasive Mechanical Ventilation or ECMO | 22.4 days | Standard Deviation 9.95 |
| Standard of Care + Cenicriviroc Matching Placebo | Duration (Days) Alive and Free of Invasive Mechanical Ventilation or ECMO | 23.2 days | Standard Deviation 9.17 |
95% CI: [-0.1, 1.8]
95% CI: [-0.3, 1.7]
95% CI: [-2, 0.4]
Secondary
Duration (Days) Alive and Free of Non-invasive Ventilation/ High Flow Oxygen
Days alive and free of non-invasive ventilation/ high flow oxygen
Time frame: Day 1 to day 28
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care + Infliximab | Duration (Days) Alive and Free of Non-invasive Ventilation/ High Flow Oxygen | 20.7 days | Standard Deviation 10.2 |
| Standard of Care + Infliximab Matching Placebo | Duration (Days) Alive and Free of Non-invasive Ventilation/ High Flow Oxygen | 19.5 days | Standard Deviation 11.02 |
| Standard of Care + Abatacept | Duration (Days) Alive and Free of Non-invasive Ventilation/ High Flow Oxygen | 20.3 days | Standard Deviation 10.16 |
| Standard of Care + Abatacept Matching Placebo | Duration (Days) Alive and Free of Non-invasive Ventilation/ High Flow Oxygen | 19.3 days | Standard Deviation 11.12 |
| Standard of Care + Cenicriviroc | Duration (Days) Alive and Free of Non-invasive Ventilation/ High Flow Oxygen | 19.4 days | Standard Deviation 11.02 |
| Standard of Care + Cenicriviroc Matching Placebo | Duration (Days) Alive and Free of Non-invasive Ventilation/ High Flow Oxygen | 20.1 days | Standard Deviation 10.47 |
95% CI: [0.2, 2.3]
95% CI: [-0.1, 2]
95% CI: [-2, 0.6]
Secondary
Duration (Days) Alive and Free of Supplemental Oxygen
Days alive and free of supplemental oxygen
Time frame: Day 1 to day 28
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care + Infliximab | Duration (Days) Alive and Free of Supplemental Oxygen | 16.3 days | Standard Deviation 9.87 |
| Standard of Care + Infliximab Matching Placebo | Duration (Days) Alive and Free of Supplemental Oxygen | 15.2 days | Standard Deviation 10.21 |
| Standard of Care + Abatacept | Duration (Days) Alive and Free of Supplemental Oxygen | 15.7 days | Standard Deviation 9.95 |
| Standard of Care + Abatacept Matching Placebo | Duration (Days) Alive and Free of Supplemental Oxygen | 15.0 days | Standard Deviation 10.35 |
| Standard of Care + Cenicriviroc | Duration (Days) Alive and Free of Supplemental Oxygen | 15.3 days | Standard Deviation 10.07 |
| Standard of Care + Cenicriviroc Matching Placebo | Duration (Days) Alive and Free of Supplemental Oxygen | 15.8 days | Standard Deviation 9.91 |
95% CI: [0, 2]
95% CI: [-0.5, 1.6]
95% CI: [-1.8, 0.7]
Secondary
Duration (Days) Alive and Out of the Hospital
Days alive and out of the hospital
Time frame: Through day 28
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care + Infliximab | Duration (Days) Alive and Out of the Hospital | 14.7 days | Standard Deviation 9.42 |
| Standard of Care + Infliximab Matching Placebo | Duration (Days) Alive and Out of the Hospital | 13.8 days | Standard Deviation 9.74 |
| Standard of Care + Abatacept | Duration (Days) Alive and Out of the Hospital | 14.1 days | Standard Deviation 9.75 |
| Standard of Care + Abatacept Matching Placebo | Duration (Days) Alive and Out of the Hospital | 13.7 days | Standard Deviation 9.86 |
| Standard of Care + Cenicriviroc | Duration (Days) Alive and Out of the Hospital | 14.2 days | Standard Deviation 9.56 |
| Standard of Care + Cenicriviroc Matching Placebo | Duration (Days) Alive and Out of the Hospital | 14.3 days | Standard Deviation 9.56 |
95% CI: [0, 2]
95% CI: [-0.7, 1.4]
95% CI: [-1.3, 1.1]
Secondary
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 10
8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best)
Time frame: Day 0 to day 10
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 45, Abatacept arms 51, CVC arms 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care + Infliximab | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 10 | 5.6 units on a scale | Standard Deviation 2.391 |
| Standard of Care + Infliximab Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 10 | 5.3 units on a scale | Standard Deviation 2.4308 |
| Standard of Care + Abatacept | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 10 | 5.4 units on a scale | Standard Deviation 2.331 |
| Standard of Care + Abatacept Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 10 | 5.3 units on a scale | Standard Deviation 2.4306 |
| Standard of Care + Cenicriviroc | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 10 | 5.3 units on a scale | Standard Deviation 2.4493 |
| Standard of Care + Cenicriviroc Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 10 | 5.3 units on a scale | Standard Deviation 2.3746 |
p-value: 0.039995% CI: [0.01, 0.61]t-test, 2 sided
p-value: 0.451595% CI: [-0.18, 0.41]t-test, 2 sided
p-value: 0.69695% CI: [-0.43, 0.29]t-test, 2 sided
Secondary
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 14
8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best)
Time frame: Day 0 to day 14
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 49, Abatacept arms 57, CVC arms 27.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care + Infliximab | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 14 | 6.0 units on a scale | Standard Deviation 2.4124 |
| Standard of Care + Infliximab Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 14 | 5.7 units on a scale | Standard Deviation 2.5183 |
| Standard of Care + Abatacept | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 14 | 5.8 units on a scale | Standard Deviation 2.3911 |
| Standard of Care + Abatacept Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 14 | 5.7 units on a scale | Standard Deviation 2.5152 |
| Standard of Care + Cenicriviroc | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 14 | 5.7 units on a scale | Standard Deviation 2.4998 |
| Standard of Care + Cenicriviroc Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 14 | 5.8 units on a scale | Standard Deviation 2.4102 |
p-value: 0.090395% CI: [-0.04, 0.57]t-test, 2 sided
p-value: 0.34895% CI: [-0.16, 0.45]t-test, 2 sided
p-value: 0.698495% CI: [-0.44, 0.29]t-test, 2 sided
Secondary
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 2
8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best)
Time frame: Day 0 to day 2
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 24, Abatacept arms 22, CVC arms 9.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care + Infliximab | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 2 | 3.5 units on a scale | Standard Deviation 0.9104 |
| Standard of Care + Infliximab Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 2 | 3.5 units on a scale | Standard Deviation 1.0515 |
| Standard of Care + Abatacept | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 2 | 3.6 units on a scale | Standard Deviation 1.0973 |
| Standard of Care + Abatacept Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 2 | 3.5 units on a scale | Standard Deviation 1.0403 |
| Standard of Care + Cenicriviroc | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 2 | 3.5 units on a scale | Standard Deviation 0.9914 |
| Standard of Care + Cenicriviroc Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 2 | 3.5 units on a scale | Standard Deviation 1.0118 |
p-value: 0.32195% CI: [-0.18, 0.06]t-test, 2 sided
p-value: 0.527595% CI: [-0.09, 0.17]t-test, 2 sided
p-value: 0.999395% CI: [-0.15, 0.15]t-test, 2 sided
Secondary
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 21
8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best)
Time frame: Day 0 to day 21
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 57, Abatacept arms 64, CVC arms 35.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care + Infliximab | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 21 | 6.3 units on a scale | Standard Deviation 2.4025 |
| Standard of Care + Infliximab Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 21 | 6.0 units on a scale | Standard Deviation 2.5732 |
| Standard of Care + Abatacept | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 21 | 6.1 units on a scale | Standard Deviation 2.4161 |
| Standard of Care + Abatacept Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 21 | 5.9 units on a scale | Standard Deviation 2.5887 |
| Standard of Care + Cenicriviroc | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 21 | 5.9 units on a scale | Standard Deviation 2.6111 |
| Standard of Care + Cenicriviroc Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 21 | 6.2 units on a scale | Standard Deviation 2.454 |
p-value: 0.04595% CI: [0.01, 0.62]t-test, 2 sided
p-value: 0.246295% CI: [-0.13, 0.5]t-test, 2 sided
p-value: 0.230495% CI: [-0.61, 0.15]t-test, 2 sided
Secondary
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 28
8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best)
Time frame: Day 0 to day 28
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Missing data: Infliximab arms 65, Abatacept arms 69, CVC arms 41.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care + Infliximab | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 28 | 6.5 units on a scale | Standard Deviation 2.4344 |
| Standard of Care + Infliximab Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 28 | 6.1 units on a scale | Standard Deviation 2.6229 |
| Standard of Care + Abatacept | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 28 | 6.4 units on a scale | Standard Deviation 2.456 |
| Standard of Care + Abatacept Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 28 | 6.1 units on a scale | Standard Deviation 2.6474 |
| Standard of Care + Cenicriviroc | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 28 | 6.1 units on a scale | Standard Deviation 2.6587 |
| Standard of Care + Cenicriviroc Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 28 | 6.3 units on a scale | Standard Deviation 2.4869 |
p-value: 0.031395% CI: [0.03, 0.66]t-test, 2 sided
p-value: 0.055595% CI: [-0.01, 0.63]t-test, 2 sided
p-value: 0.27195% CI: [-0.6, 0.17]t-test, 2 sided
Secondary
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 4
8 point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best)
Time frame: Day 0 to day 4
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.Missing data: Infliximab arms 25, Abatacept arms 32, CVC arms 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care + Infliximab | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 4 | 3.9 units on a scale | Standard Deviation 1.6004 |
| Standard of Care + Infliximab Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 4 | 3.9 units on a scale | Standard Deviation 1.532 |
| Standard of Care + Abatacept | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 4 | 4.0 units on a scale | Standard Deviation 1.6526 |
| Standard of Care + Abatacept Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 4 | 3.9 units on a scale | Standard Deviation 1.5468 |
| Standard of Care + Cenicriviroc | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 4 | 3.9 units on a scale | Standard Deviation 1.6385 |
| Standard of Care + Cenicriviroc Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 4 | 3.9 units on a scale | Standard Deviation 1.5624 |
p-value: 0.498295% CI: [-0.13, 0.26]t-test, 2 sided
p-value: 0.349195% CI: [-0.1, 0.29]t-test, 2 sided
p-value: 0.90295% CI: [-0.25, 0.22]t-test, 2 sided
Secondary
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 7
8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities=best)
Time frame: Day 0 to day 7
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.Missing data: Infliximab arms 35, Abatacept arms 43, CVC arms 19.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care + Infliximab | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 7 | 5.0 units on a scale | Standard Deviation 2.2738 |
| Standard of Care + Infliximab Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 7 | 4.8 units on a scale | Standard Deviation 2.247 |
| Standard of Care + Abatacept | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 7 | 4.9 units on a scale | Standard Deviation 2.2261 |
| Standard of Care + Abatacept Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 7 | 4.8 units on a scale | Standard Deviation 2.2585 |
| Standard of Care + Cenicriviroc | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 7 | 4.8 units on a scale | Standard Deviation 2.2636 |
| Standard of Care + Cenicriviroc Matching Placebo | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 7 | 4.9 units on a scale | Standard Deviation 2.2475 |
p-value: 0.084295% CI: [-0.03, 0.52]t-test, 2 sided
p-value: 0.532895% CI: [-0.19, 0.37]t-test, 2 sided
p-value: 0.472795% CI: [-0.46, 0.21]t-test, 2 sided
Secondary
Mortality Through 14 Days
mortality at day 14
Time frame: Day 1-14
Population: Intention to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care + Infliximab | Mortality Through 14 Days | 29 Participants |
| Standard of Care + Infliximab Matching Placebo | Mortality Through 14 Days | 42 Participants |
| Standard of Care + Abatacept | Mortality Through 14 Days | 24 Participants |
| Standard of Care + Abatacept Matching Placebo | Mortality Through 14 Days | 40 Participants |
| Standard of Care + Cenicriviroc | Mortality Through 14 Days | 31 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Mortality Through 14 Days | 25 Participants |
p-value: 0.098895% CI: [0.367, 1.09]Regression, Logistic
p-value: 0.035495% CI: [0.317, 0.96]Regression, Logistic
p-value: 0.413295% CI: [0.703, 2.355]Regression, Logistic
Secondary
Mortality Through 28 Days
mortality at day 28
Time frame: Day 1-28
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care + Infliximab | Mortality Through 28 Days | 53 Participants |
| Standard of Care + Infliximab Matching Placebo | Mortality Through 28 Days | 75 Participants |
| Standard of Care + Abatacept | Mortality Through 28 Days | 56 Participants |
| Standard of Care + Abatacept Matching Placebo | Mortality Through 28 Days | 77 Participants |
| Standard of Care + Cenicriviroc | Mortality Through 28 Days | 49 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Mortality Through 28 Days | 42 Participants |
p-value: 0.022995% CI: [0.403, 0.935]Regression, Logistic
p-value: 0.028195% CI: [0.416, 0.951]Regression, Logistic
p-value: 0.54195% CI: [0.711, 1.917]Regression, Logistic
Secondary
Number of Participants Who Met a One Point Improvement in One Category From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale
8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best). Number of people who met a 1 point improvement. The scale used in this study is as follows (from worst to best): 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical in-patient care; This would include those kept in hospital for quarantine/infection control/social reasons, awaiting bed in rehabilitation facility or homecare, etc. 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities.
Time frame: Day 1-day 28
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care + Infliximab | Number of Participants Who Met a One Point Improvement in One Category From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 446 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants Who Met a One Point Improvement in One Category From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 429 Participants |
| Standard of Care + Abatacept | Number of Participants Who Met a One Point Improvement in One Category From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 435 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants Who Met a One Point Improvement in One Category From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 421 Participants |
| Standard of Care + Cenicriviroc | Number of Participants Who Met a One Point Improvement in One Category From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 287 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants Who Met a One Point Improvement in One Category From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 302 Participants |
p-value: 0.160195% CI: [1, 1.28]Fine-Gray Proportional Hazards Model
p-value: 0.35595% CI: [0.97, 1.24]Fine-Gray Proportional Hazards Model
p-value: 0.238695% CI: [0.8, 1.07]Fine-Gray Proportional Hazards Model
Secondary
Number of Participants Who Met a One Point Improvement in Two Categories From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale
8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best). Number of people who met a two category improvement. The scale used in this study is as follows (from worst to best): 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical in-patient care; This would include those kept in hospital for quarantine/infection control/social reasons, awaiting bed in rehabilitation facility or homecare, etc. 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities.
Time frame: Day 1- day 28
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care + Infliximab | Number of Participants Who Met a One Point Improvement in Two Categories From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 429 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants Who Met a One Point Improvement in Two Categories From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 415 Participants |
| Standard of Care + Abatacept | Number of Participants Who Met a One Point Improvement in Two Categories From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 421 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants Who Met a One Point Improvement in Two Categories From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 406 Participants |
| Standard of Care + Cenicriviroc | Number of Participants Who Met a One Point Improvement in Two Categories From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 282 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants Who Met a One Point Improvement in Two Categories From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 292 Participants |
p-value: 0.151995% CI: [0.98, 1.26]Fine-Gray Proportional Hazards Model
p-value: 0.260595% CI: [0.98, 1.26]Fine-Gray Proportional Hazards Model
p-value: 0.435995% CI: [0.83, 1.13]Fine-Gray Proportional Hazards Model
Secondary
Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale
8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) To determine a participant's clinical status using the ordinal scale their clinical status was collected at Day 15 assessing day 14. The scale used in this study is as follows (from worst to best): 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical in-patient care; This would include those kept in hospital for quarantine/infection control/social reasons, awaiting bed in rehabilitation facility or homecare, etc. 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized,
Time frame: Day 14
Population: Intention to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Missing data: Infliximab arms 49, Abatacept arms 57, CVC arms 27. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 2-Hospitalized, on invasive mechanical ventilation or ECMO | 60 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care | 2 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care | 4 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 8-Not hospitalized | 185 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 7-Not hospitalized, limitation on activities and/or requiring home oxygen | 163 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 1-Death | 29 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices | 19 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 4-Hospitalized, requiring supplemental oxygen | 44 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices | 23 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 8-Not hospitalized | 155 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 1-Death | 42 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 4-Hospitalized, requiring supplemental oxygen | 34 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care | 11 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 7-Not hospitalized, limitation on activities and/or requiring home oxygen | 174 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 2-Hospitalized, on invasive mechanical ventilation or ECMO | 65 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care | 2 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care | 0 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care | 13 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 7-Not hospitalized, limitation on activities and/or requiring home oxygen | 174 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 2-Hospitalized, on invasive mechanical ventilation or ECMO | 63 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices | 31 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 4-Hospitalized, requiring supplemental oxygen | 38 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 8-Not hospitalized | 150 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 1-Death | 24 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 7-Not hospitalized, limitation on activities and/or requiring home oxygen | 173 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 8-Not hospitalized | 147 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 2-Hospitalized, on invasive mechanical ventilation or ECMO | 66 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices | 26 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 4-Hospitalized, requiring supplemental oxygen | 34 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care | 11 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 1-Death | 40 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care | 2 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 4-Hospitalized, requiring supplemental oxygen | 22 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 7-Not hospitalized, limitation on activities and/or requiring home oxygen | 134 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care | 1 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 1-Death | 31 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 2-Hospitalized, on invasive mechanical ventilation or ECMO | 41 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices | 17 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 8-Not hospitalized | 98 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care | 6 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 8-Not hospitalized | 98 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 1-Death | 25 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 2-Hospitalized, on invasive mechanical ventilation or ECMO | 38 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices | 15 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 4-Hospitalized, requiring supplemental oxygen | 29 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care | 10 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care | 1 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 7-Not hospitalized, limitation on activities and/or requiring home oxygen | 130 Participants |
p-value: 0.021395% CI: [1.041, 1.647]Regression, Logistic
p-value: 0.173295% CI: [0.932, 1.48]Regression, Logistic
p-value: 0.682395% CI: [0.717, 1.243]Regression, Logistic
Secondary
Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale
8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) To determine a participant's clinical status using the ordinal scale their clinical status was collected at Day 29 assessing day 28. The scale used in this study is as follows (from worst to best): 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical in-patient care; This would include those kept in hospital for quarantine/infection control/social reasons, awaiting bed in rehabilitation facility or homecare, etc. 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized,
Time frame: Day 28
Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 65, Abatacept arms 69, CVC arms 41.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care | 3 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care | 2 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 8-Not hospitalized | 258 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 7-Not hospitalized, limitation on activities and/or requiring home oxygen | 135 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices | 6 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 1-Death | 53 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 4-Hospitalized, requiring supplemental oxygen | 11 Participants |
| Standard of Care + Infliximab | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 2-Hospitalized, on invasive mechanical ventilation or ECMO | 28 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 7-Not hospitalized, limitation on activities and/or requiring home oxygen | 156 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 1-Death | 75 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 4-Hospitalized, requiring supplemental oxygen | 10 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices | 7 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 8-Not hospitalized | 217 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care | 6 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care | 2 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 2-Hospitalized, on invasive mechanical ventilation or ECMO | 27 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care | 1 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 2-Hospitalized, on invasive mechanical ventilation or ECMO | 27 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 1-Death | 56 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 8-Not hospitalized | 231 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 4-Hospitalized, requiring supplemental oxygen | 10 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care | 8 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 7-Not hospitalized, limitation on activities and/or requiring home oxygen | 149 Participants |
| Standard of Care + Abatacept | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices | 5 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 7-Not hospitalized, limitation on activities and/or requiring home oxygen | 156 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 8-Not hospitalized | 207 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 2-Hospitalized, on invasive mechanical ventilation or ECMO | 26 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices | 8 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 4-Hospitalized, requiring supplemental oxygen | 12 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 1-Death | 77 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care | 5 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care | 2 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care | 2 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 7-Not hospitalized, limitation on activities and/or requiring home oxygen | 109 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care | 0 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices | 7 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 2-Hospitalized, on invasive mechanical ventilation or ECMO | 25 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 4-Hospitalized, requiring supplemental oxygen | 4 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 8-Not hospitalized | 142 Participants |
| Standard of Care + Cenicriviroc | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 1-Death | 49 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 8-Not hospitalized | 149 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 1-Death | 42 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 2-Hospitalized, on invasive mechanical ventilation or ECMO | 19 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices | 5 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 4-Hospitalized, requiring supplemental oxygen | 8 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care | 4 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care | 2 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 7-Not hospitalized, limitation on activities and/or requiring home oxygen | 115 Participants |
p-value: 0.003295% CI: [1.129, 1.825]Regression, Logistic
p-value: 0.022895% CI: [1.041, 1.718]Regression, Logistic
p-value: 0.499495% CI: [0.675, 1.211]Regression, Logistic
Secondary
Number of Patients With Adverse Events Leading to Dose Modification
Number of patients with adverse events (serious and non serious) leading to dose modification
Time frame: Day 1-28
Population: Modified intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care + Infliximab | Number of Patients With Adverse Events Leading to Dose Modification | 4 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Patients With Adverse Events Leading to Dose Modification | 7 Participants |
| Standard of Care + Abatacept | Number of Patients With Adverse Events Leading to Dose Modification | 4 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Patients With Adverse Events Leading to Dose Modification | 7 Participants |
| Standard of Care + Cenicriviroc | Number of Patients With Adverse Events Leading to Dose Modification | 34 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Patients With Adverse Events Leading to Dose Modification | 7 Participants |
p-value: 0.362895% CI: [0.165, 1.931]Log Rank
p-value: 0.370195% CI: [0.167, 1.948]Log Rank
p-value: 0.000195% CI: [2.211, 11.251]Log Rank
Secondary
Number of Patients With Grade 3 and 4 Adverse Events
Cumulative incidence of adverse events of grade 3 and 4
Time frame: Day 28
Population: Modified intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care + Infliximab | Number of Patients With Grade 3 and 4 Adverse Events | 137 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Patients With Grade 3 and 4 Adverse Events | 126 Participants |
| Standard of Care + Abatacept | Number of Patients With Grade 3 and 4 Adverse Events | 124 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Patients With Grade 3 and 4 Adverse Events | 132 Participants |
| Standard of Care + Cenicriviroc | Number of Patients With Grade 3 and 4 Adverse Events | 101 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Patients With Grade 3 and 4 Adverse Events | 94 Participants |
p-value: 0.517595% CI: [0.85, 1.38]Log Rank
p-value: 0.521695% CI: [0.722, 1.179]Log Rank
p-value: 0.613595% CI: [0.812, 1.424]Log Rank
Secondary
Number of Patients With New Mechanical Ventilation or ECMO Use
Number of patients with new mechanical ventilation or ECMO use
Time frame: Day 1 to day 28
Population: Intent to treat in patients that were not receiving ECMO at baseline. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care + Infliximab | Number of Patients With New Mechanical Ventilation or ECMO Use | 70 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Patients With New Mechanical Ventilation or ECMO Use | 76 Participants |
| Standard of Care + Abatacept | Number of Patients With New Mechanical Ventilation or ECMO Use | 71 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Patients With New Mechanical Ventilation or ECMO Use | 77 Participants |
| Standard of Care + Cenicriviroc | Number of Patients With New Mechanical Ventilation or ECMO Use | 62 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Patients With New Mechanical Ventilation or ECMO Use | 55 Participants |
95% CI: [-5.7, 3.5]
95% CI: [-6, 3.3]
95% CI: [-3.7, 8]
Secondary
Number of Patients With New Non-invasive Ventilation/High Flow Oxygen Use
Number of patients with new non-invasive ventilation/high flow oxygen use
Time frame: Day 1-day 28
Population: Intent to treat in patients who were not taking any supplemental or non-invasive/high flow oxygen at baseline. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care + Infliximab | Number of Patients With New Non-invasive Ventilation/High Flow Oxygen Use | 68 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Patients With New Non-invasive Ventilation/High Flow Oxygen Use | 89 Participants |
| Standard of Care + Abatacept | Number of Patients With New Non-invasive Ventilation/High Flow Oxygen Use | 81 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Patients With New Non-invasive Ventilation/High Flow Oxygen Use | 92 Participants |
| Standard of Care + Cenicriviroc | Number of Patients With New Non-invasive Ventilation/High Flow Oxygen Use | 64 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Patients With New Non-invasive Ventilation/High Flow Oxygen Use | 67 Participants |
95% CI: [-14, 0]
95% CI: [-11.1, 3.4]
95% CI: [-10.1, 8.1]
Secondary
Number of Patients With New Supplemental Oxygen Use
Number of patients with new supplemental oxygen use
Time frame: Day 1-day 28
Population: Intent to treat in patients who were not taking any supplemental oxygen at baseline. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care + Infliximab | Number of Patients With New Supplemental Oxygen Use | 13 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Patients With New Supplemental Oxygen Use | 5 Participants |
| Standard of Care + Abatacept | Number of Patients With New Supplemental Oxygen Use | 11 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Patients With New Supplemental Oxygen Use | 6 Participants |
| Standard of Care + Cenicriviroc | Number of Patients With New Supplemental Oxygen Use | 4 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Patients With New Supplemental Oxygen Use | 4 Participants |
95% CI: [-0.4, 53.7]
95% CI: [-14.8, 40]
95% CI: [-38.7, 26.6]
Secondary
Number of Patients With SAEs Through Day 28
Cumulative Incidence of SAEs through day 28
Time frame: Day 28
Population: Modified intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care + Infliximab | Number of Patients With SAEs Through Day 28 | 112 Participants |
| Standard of Care + Infliximab Matching Placebo | Number of Patients With SAEs Through Day 28 | 124 Participants |
| Standard of Care + Abatacept | Number of Patients With SAEs Through Day 28 | 116 Participants |
| Standard of Care + Abatacept Matching Placebo | Number of Patients With SAEs Through Day 28 | 131 Participants |
| Standard of Care + Cenicriviroc | Number of Patients With SAEs Through Day 28 | 95 Participants |
| Standard of Care + Cenicriviroc Matching Placebo | Number of Patients With SAEs Through Day 28 | 80 Participants |
p-value: 0.316995% CI: [0.68, 1.133]Log Rank
p-value: 0.24895% CI: [0.672, 1.108]Log Rank
p-value: 0.24995% CI: [0.885, 1.604]Log Rank