Coronavirus Disease 2019 (COVID-19)
Conditions
Brief summary
This study evaluates the efficacy and safety of efprezimod alfa in hospitalized adult participants who are diagnosed with coronavirus disease 2019 (COVID-19) and receiving oxygen support. The primary hypothesis of the study is clinical improvement in the experimental group versus the control group.
Interventions
DRUGEfprezimod alfa
Efprezimod alfa is given on Day 1.
DRUGPlacebo
Placebo is given on Day 1.
Sponsors
Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with coronavirus disease 2019 (COVID-19) and confirmed severe acute respiratory syndrome coronavirus 2 (SARS-coV-2) viral infection * Severe or critical COVID-19, or National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal score 2, 3 or 4 (Scale 2: requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Scale 3: non-invasive ventilation or high flow oxygen devices; Scale 4: supplemental oxygen support; a peripheral capillary oxygen saturation (SpO2) \</= 94% or tachypnea (respiratory rate \>/= 24 breaths/min). Intubation should be within 7 days
Exclusion criteria
* Participants who are pregnant, breastfeeding, or have a positive pregnancy test result before enrollment * Participants previously enrolled in the efprezimod alfa study * Intubation for invasive mechanical ventilation is over 7 days * Documented acute renal or hepatic failure * The investigator believes that participating in the trial is not in the best interests of the participant, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status | Up to Day 29 | Time to improvement in COVID-19 clinical status: defined as time (days) required from start of treatment to improvement of clinical status severe - moderate/mild or improvement from score 2-4 to ≥5 sustained without drop below 5 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up) per National Institute of Allergy & Infectious Diseases (NIAID) ordinal scale graded: 1=Death; 2=Hospitalized, on invasive mechanical ventilation (IMV)/extracorporeal membrane oxygenation (ECMO); 3=Hospitalized, on non-invasive ventilation (NIV)/high flow oxygen devices; 4=Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, don't require medical care; 7=Not hospitalized, limitation on activities &/or require home oxygen; 8=Not hospitalized, no limitations on activities. Median time & 95% confidence intervals (CIs) were reported using Brookmeyer-Crowley method. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to 30 days | An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, only AEs with Common Terminology Criteria for AE (CTACAE) grade ≥3 were included. The number of participants who experienced an AE were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Disease Progression in Clinical Status of COVID-19 | Up to Day 29 | Time to disease progression in clinical status is defined as the time (days) for progression from NIAID score (3 or 4) to (2 or 1) or from 2 to 1 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up). NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not Hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities. |
| Number of Participants Who Died Due to Any Cause | Up to Day 29 | Number of participants who died due to any cause were assessed per protocol on Day 15 and Day 29. |
| Rate of Clinical Relapse | Up to Day 29 | Rate of clinical relapse was defined as the percentage of participants who had initially reached score 5 on NIAID ordinal scale for more than one day but subsequently became dependent on oxygen support for more than 1 day within 28 days from randomization after initial recovery with a total follow-up period of 29 days (Day 1 of randomization plus 28 days of follow-up). NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities. Clopper-Pearson method was used to report the 95% CI. |
| Conversion Rate of COVID-19 Clinical Status | Up to Day 15 | Conversion rate of COVID-19 clinical status on days 8 and 15 was defined as the percentage of participants who changed from NIAID ordinal score 2, 3, 4 to score 5 or higher and reported. NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities. |
| Time to Hospital Discharge | Up to Day 29 | The hospital discharge time was defined as the time from randomization to discharge from the hospital and reported. Time to Hospital Discharge (days) from randomization is calculated as: Time to hospital discharge = Date of hospital discharge - Date of randomization. |
| Duration of Pressors | Up to Day 29 | Pressor administration included norepinephrine, epinephrine, vasopressin, dopamine and phenylephrine. Duration of pressor (days) was defined as: End Date of Pressor - Start Date of Pressor + 1 and reported. |
| Duration of ECMO | Up to Day 29 | Duration of ECMO treatment (days) was calculated as: End Date of ECMO Treatment - Start Date of ECMO Treatment + 1 and reported. |
| Duration of High Flow Oxygen Therapy | Up to Day 29 | Duration of oxygen therapy (oxygen inhalation by high flow nasal cannula or mask) (days) was calculated as: End Date of high flow oxygen therapy - Start Date of high flow oxygen therapy + 1 and reported. |
| Length of Hospital Stay | Up to 90 days | Length of Hospital Stay (Days) was defined as date of discharge - date of admission + 1 and reported. Data presented below include hospitalization time prior to enrollment in the study with total duration of up to 90 days. |
| Change From Baseline in Absolute Lymphocyte Count | Baseline and up to Day 15 | Blood samples were collected to present the change from baseline in the absolute lymphocyte count on days 1, 4, 8, and 15 in peripheral blood. To calculate the change from baseline in absolute lymphocyte count at specific timepoints (Days 1, 4, 8 and 15), only the participants who had both, a baseline, and a post baseline value at the specific timepoint (Days 1, 4, 8 and 15) were included in the analysis. |
| Change From Baseline in D-Dimer Concentration | Baseline and up to Day 15 | Blood samples were collected to present the change from baseline in the D-dimer concentration on days 4, 8 and 15 in peripheral blood. To calculate change from baseline in D-dimer concentration at specific timepoints (Days 4, 8 and 15), only the participants who had both, a baseline, and a post baseline value at the specific timepoint (Days 4, 8 and 15) were included in the analysis. |
| Duration of MV | Up to Day 29 | MV included IMV and NIV. Duration of MV (days) was calculated as: End Date of MV - Start Date of MV + 1 and reported. |
| Percentage of Participants Who Died or Had Respiratory Failure (RF) | Up to Day 29 | RF was defined as the need for any of the following: 1) mechanical ventilation (MV), 2) ECMO, 3) NIV, or 4) high flow oxygen devices. Percentage of participants who died or had respiratory failure by Day 29 were reported. |
Countries
United States
Participant flow
Pre-assignment details
Of the 234 participants enrolled or randomized in the study, 229 participants received study medication and were evaluable for safety analyses.
Participants by arm
| Arm | Count |
|---|---|
| CD24Fc Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1. | 116 |
| Placebo Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1. | 118 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 16 | 18 |
| Overall Study | Incomplete assessments | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | CD24Fc |
|---|---|---|---|
| Age, Continuous | 57.8 Years STANDARD_DEVIATION 14.2 | 57.8 Years STANDARD_DEVIATION 14.1 | 57.8 Years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants | 85 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 149 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 50 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 34 Participants | 67 Participants | 33 Participants |
| Race (NIH/OMB) White | 58 Participants | 111 Participants | 53 Participants |
| Sex: Female, Male Female | 44 Participants | 89 Participants | 45 Participants |
| Sex: Female, Male Male | 74 Participants | 145 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 116 | 18 / 118 |
| other Total, other adverse events | 0 / 114 | 0 / 115 |
| serious Total, serious adverse events | 26 / 114 | 27 / 115 |
Outcome results
Primary
Number of Participants Who Experience an Adverse Event (AE)
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, only AEs with Common Terminology Criteria for AE (CTACAE) grade ≥3 were included. The number of participants who experienced an AE were reported.
Time frame: Up to 30 days
Population: All randomized participants who received at least one dose of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CD24Fc | Number of Participants Who Experience an Adverse Event (AE) | 32 Participants |
| Placebo | Number of Participants Who Experience an Adverse Event (AE) | 35 Participants |
Primary
Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status
Time to improvement in COVID-19 clinical status: defined as time (days) required from start of treatment to improvement of clinical status severe - moderate/mild or improvement from score 2-4 to ≥5 sustained without drop below 5 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up) per National Institute of Allergy & Infectious Diseases (NIAID) ordinal scale graded: 1=Death; 2=Hospitalized, on invasive mechanical ventilation (IMV)/extracorporeal membrane oxygenation (ECMO); 3=Hospitalized, on non-invasive ventilation (NIV)/high flow oxygen devices; 4=Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, don't require medical care; 7=Not hospitalized, limitation on activities &/or require home oxygen; 8=Not hospitalized, no limitations on activities. Median time & 95% confidence intervals (CIs) were reported using Brookmeyer-Crowley method.
Time frame: Up to Day 29
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CD24Fc | Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status | 6.0 Days |
| Placebo | Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status | 10.5 Days |
p-value: 0.036795% CI: [1.02, 1.918]Log Rank
Secondary
Change From Baseline in Absolute Lymphocyte Count
Blood samples were collected to present the change from baseline in the absolute lymphocyte count on days 1, 4, 8, and 15 in peripheral blood. To calculate the change from baseline in absolute lymphocyte count at specific timepoints (Days 1, 4, 8 and 15), only the participants who had both, a baseline, and a post baseline value at the specific timepoint (Days 1, 4, 8 and 15) were included in the analysis.
Time frame: Baseline and up to Day 15
Population: All randomized participants with lymphocyte data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD24Fc | Change From Baseline in Absolute Lymphocyte Count | Day 1 | 5.317 10^9 Cells/Liter | Standard Deviation 8.0772 |
| CD24Fc | Change From Baseline in Absolute Lymphocyte Count | Change from Baseline to Day 1 | 0.374 10^9 Cells/Liter | Standard Deviation 2.0467 |
| CD24Fc | Change From Baseline in Absolute Lymphocyte Count | Day 8 | 2.557 10^9 Cells/Liter | Standard Deviation 4.7147 |
| CD24Fc | Change From Baseline in Absolute Lymphocyte Count | Change from Baseline to Day 4 | 0.219 10^9 Cells/Liter | Standard Deviation 5.2971 |
| CD24Fc | Change From Baseline in Absolute Lymphocyte Count | Day 4 | 2.373 10^9 Cells/Liter | Standard Deviation 5.7549 |
| CD24Fc | Change From Baseline in Absolute Lymphocyte Count | Change from Baseline to Day 8 | 0.575 10^9 Cells/Liter | Standard Deviation 5.5692 |
| CD24Fc | Change From Baseline in Absolute Lymphocyte Count | Day 15 | 1.965 10^9 Cells/Liter | Standard Deviation 3.8555 |
| CD24Fc | Change From Baseline in Absolute Lymphocyte Count | Change from Baseline to Day 15 | 0.558 10^9 Cells/Liter | Standard Deviation 4.3613 |
| CD24Fc | Change From Baseline in Absolute Lymphocyte Count | Baseline | 2.357 10^9 Cells/Liter | Standard Deviation 5.1173 |
| Placebo | Change From Baseline in Absolute Lymphocyte Count | Change from Baseline to Day 15 | -0.280 10^9 Cells/Liter | Standard Deviation 5.1603 |
| Placebo | Change From Baseline in Absolute Lymphocyte Count | Baseline | 2.437 10^9 Cells/Liter | Standard Deviation 4.766 |
| Placebo | Change From Baseline in Absolute Lymphocyte Count | Day 1 | 5.125 10^9 Cells/Liter | Standard Deviation 7.3979 |
| Placebo | Change From Baseline in Absolute Lymphocyte Count | Day 4 | 2.461 10^9 Cells/Liter | Standard Deviation 4.2074 |
| Placebo | Change From Baseline in Absolute Lymphocyte Count | Day 8 | 1.839 10^9 Cells/Liter | Standard Deviation 2.7319 |
| Placebo | Change From Baseline in Absolute Lymphocyte Count | Day 15 | 2.378 10^9 Cells/Liter | Standard Deviation 4.6402 |
| Placebo | Change From Baseline in Absolute Lymphocyte Count | Change from Baseline to Day 1 | -0.148 10^9 Cells/Liter | Standard Deviation 0.7985 |
| Placebo | Change From Baseline in Absolute Lymphocyte Count | Change from Baseline to Day 4 | 0.053 10^9 Cells/Liter | Standard Deviation 2.28 |
| Placebo | Change From Baseline in Absolute Lymphocyte Count | Change from Baseline to Day 8 | -0.491 10^9 Cells/Liter | Standard Deviation 3.1128 |
Secondary
Change From Baseline in D-Dimer Concentration
Blood samples were collected to present the change from baseline in the D-dimer concentration on days 4, 8 and 15 in peripheral blood. To calculate change from baseline in D-dimer concentration at specific timepoints (Days 4, 8 and 15), only the participants who had both, a baseline, and a post baseline value at the specific timepoint (Days 4, 8 and 15) were included in the analysis.
Time frame: Baseline and up to Day 15
Population: All randomized participants with D-dimer concentration data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD24Fc | Change From Baseline in D-Dimer Concentration | Day 8 | 13.224 nmol/Liter | Standard Deviation 17.4246 |
| CD24Fc | Change From Baseline in D-Dimer Concentration | Change from Baseline to Day 4 | -0.427 nmol/Liter | Standard Deviation 9.6796 |
| CD24Fc | Change From Baseline in D-Dimer Concentration | Day 4 | 10.451 nmol/Liter | Standard Deviation 16.1924 |
| CD24Fc | Change From Baseline in D-Dimer Concentration | Change from Baseline to Day 8 | -397.547 nmol/Liter | Standard Deviation 2419.1594 |
| CD24Fc | Change From Baseline in D-Dimer Concentration | Day 15 | 11.700 nmol/Liter | Standard Deviation 7.9524 |
| CD24Fc | Change From Baseline in D-Dimer Concentration | Change from Baseline to Day 15 | 3.076 nmol/Liter | Standard Deviation 10.0044 |
| CD24Fc | Change From Baseline in D-Dimer Concentration | Baseline | 153.717 nmol/Liter | Standard Deviation 1457.6865 |
| Placebo | Change From Baseline in D-Dimer Concentration | Change from Baseline to Day 15 | -3.591 nmol/Liter | Standard Deviation 19.0945 |
| Placebo | Change From Baseline in D-Dimer Concentration | Baseline | 9.767 nmol/Liter | Standard Deviation 12.4347 |
| Placebo | Change From Baseline in D-Dimer Concentration | Day 4 | 13.885 nmol/Liter | Standard Deviation 33.0328 |
| Placebo | Change From Baseline in D-Dimer Concentration | Day 8 | 13.349 nmol/Liter | Standard Deviation 17.2777 |
| Placebo | Change From Baseline in D-Dimer Concentration | Day 15 | 13.892 nmol/Liter | Standard Deviation 19.9369 |
| Placebo | Change From Baseline in D-Dimer Concentration | Change from Baseline to Day 4 | 3.971 nmol/Liter | Standard Deviation 34.9427 |
| Placebo | Change From Baseline in D-Dimer Concentration | Change from Baseline to Day 8 | 0.703 nmol/Liter | Standard Deviation 18.3254 |
Secondary
Conversion Rate of COVID-19 Clinical Status
Conversion rate of COVID-19 clinical status on days 8 and 15 was defined as the percentage of participants who changed from NIAID ordinal score 2, 3, 4 to score 5 or higher and reported. NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities.
Time frame: Up to Day 15
Population: All randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD24Fc | Conversion Rate of COVID-19 Clinical Status | Day 8 | 55.2 Percentage of participants |
| CD24Fc | Conversion Rate of COVID-19 Clinical Status | Day 15 | 71.6 Percentage of participants |
| Placebo | Conversion Rate of COVID-19 Clinical Status | Day 8 | 42.4 Percentage of participants |
| Placebo | Conversion Rate of COVID-19 Clinical Status | Day 15 | 55.9 Percentage of participants |
Secondary
Duration of ECMO
Duration of ECMO treatment (days) was calculated as: End Date of ECMO Treatment - Start Date of ECMO Treatment + 1 and reported.
Time frame: Up to Day 29
Population: All randomized participants who received ECMO
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Duration of ECMO | 11.0 Days |
Secondary
Duration of High Flow Oxygen Therapy
Duration of oxygen therapy (oxygen inhalation by high flow nasal cannula or mask) (days) was calculated as: End Date of high flow oxygen therapy - Start Date of high flow oxygen therapy + 1 and reported.
Time frame: Up to Day 29
Population: All randomized participants who received high flow oxygen therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD24Fc | Duration of High Flow Oxygen Therapy | 13.8 Days | Standard Deviation 12.91 |
| Placebo | Duration of High Flow Oxygen Therapy | 13.0 Days | Standard Deviation 10.12 |
Secondary
Duration of MV
MV included IMV and NIV. Duration of MV (days) was calculated as: End Date of MV - Start Date of MV + 1 and reported.
Time frame: Up to Day 29
Population: All randomized participants who received MV
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD24Fc | Duration of MV | 14.3 Days | Standard Deviation 12.34 |
| Placebo | Duration of MV | 14.3 Days | Standard Deviation 8.85 |
Secondary
Duration of Pressors
Pressor administration included norepinephrine, epinephrine, vasopressin, dopamine and phenylephrine. Duration of pressor (days) was defined as: End Date of Pressor - Start Date of Pressor + 1 and reported.
Time frame: Up to Day 29
Population: All randomized participants who received pressors
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD24Fc | Duration of Pressors | 6.3 Days | Standard Deviation 5.59 |
| Placebo | Duration of Pressors | 7.9 Days | Standard Deviation 8.86 |
Secondary
Length of Hospital Stay
Length of Hospital Stay (Days) was defined as date of discharge - date of admission + 1 and reported. Data presented below include hospitalization time prior to enrollment in the study with total duration of up to 90 days.
Time frame: Up to 90 days
Population: All randomized participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD24Fc | Length of Hospital Stay | 16.6 Days | Standard Deviation 16.27 |
| Placebo | Length of Hospital Stay | 18.2 Days | Standard Deviation 13.54 |
Secondary
Number of Participants Who Died Due to Any Cause
Number of participants who died due to any cause were assessed per protocol on Day 15 and Day 29.
Time frame: Up to Day 29
Population: All randomized participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CD24Fc | Number of Participants Who Died Due to Any Cause | Day 15 | 11 Participants |
| CD24Fc | Number of Participants Who Died Due to Any Cause | Day 29 | 16 Participants |
| Placebo | Number of Participants Who Died Due to Any Cause | Day 15 | 8 Participants |
| Placebo | Number of Participants Who Died Due to Any Cause | Day 29 | 18 Participants |
Comparison: Day 15p-value: 0.449195% CI: [-0.043, 0.097]Chi-squared
Comparison: Day 29p-value: 0.751295% CI: [-0.1049, 0.0756]Chi-squared
Secondary
Percentage of Participants Who Died or Had Respiratory Failure (RF)
RF was defined as the need for any of the following: 1) mechanical ventilation (MV), 2) ECMO, 3) NIV, or 4) high flow oxygen devices. Percentage of participants who died or had respiratory failure by Day 29 were reported.
Time frame: Up to Day 29
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CD24Fc | Percentage of Participants Who Died or Had Respiratory Failure (RF) | 22.4 Percentage of Participants |
| Placebo | Percentage of Participants Who Died or Had Respiratory Failure (RF) | 28.0 Percentage of Participants |
p-value: 0.328195% CI: [-0.1665, 0.0555]Chi-squared
Secondary
Rate of Clinical Relapse
Rate of clinical relapse was defined as the percentage of participants who had initially reached score 5 on NIAID ordinal scale for more than one day but subsequently became dependent on oxygen support for more than 1 day within 28 days from randomization after initial recovery with a total follow-up period of 29 days (Day 1 of randomization plus 28 days of follow-up). NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities. Clopper-Pearson method was used to report the 95% CI.
Time frame: Up to Day 29
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CD24Fc | Rate of Clinical Relapse | 4.3 Percentage of Participants |
| Placebo | Rate of Clinical Relapse | 6.8 Percentage of Participants |
Secondary
Time to Disease Progression in Clinical Status of COVID-19
Time to disease progression in clinical status is defined as the time (days) for progression from NIAID score (3 or 4) to (2 or 1) or from 2 to 1 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up). NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not Hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities.
Time frame: Up to Day 29
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CD24Fc | Time to Disease Progression in Clinical Status of COVID-19 | NA Days |
| Placebo | Time to Disease Progression in Clinical Status of COVID-19 | NA Days |
p-value: 0.030695% CI: [0.327, 0.954]Log Rank
Secondary
Time to Hospital Discharge
The hospital discharge time was defined as the time from randomization to discharge from the hospital and reported. Time to Hospital Discharge (days) from randomization is calculated as: Time to hospital discharge = Date of hospital discharge - Date of randomization.
Time frame: Up to Day 29
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CD24Fc | Time to Hospital Discharge | 7.0 Days |
| Placebo | Time to Hospital Discharge | 10.5 Days |
p-value: 0.031195% CI: [1.031, 1.945]Log Rank