Covid19
Conditions
Keywords
SARS-CoV-2, corona virus, coronavirus, corona
Brief summary
Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection
Detailed description
This is a randomized, placebo-controlled clinical study to assess the safety and efficacy of EDP1815 in patients hospitalized with COVID-19 infection. The study is designed to evaluate the efficacy of EDP1815 at reducing time to resolution of symptoms, preventing progression of COVID-19 symptoms and preventing COVID-Related Complications (CRC)
Interventions
DRUGEDP1815
EDP1815 is an orally administered monoclonal microbe
DRUGPlacebo
Placebo oral capsule
Sponsors
Evelo Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Fully blinded to the participants, investigator, and sponsor
Intervention model description
Patients will be randomized to either the active (EDP1815) or placebo group (1:1 randomization), in addition to standard of care. Dosing will be initiated on a twice daily regime for the first 3 days (6 doses) and then once daily for the remaining 11 days (14 days total treatment course).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Hospitalized within the last 36 hours. 2. Receiving any form of supplementary oxygen therapy at baseline. 3. Confirmed COVID-19 viral infection by RTPCR at screening. 4. Age: 1. 18-65 years old, OR 2. \>65 year-olds can be included after Data Monitoring Committee (DMC) approval Key
Exclusion criteria
1. Contraindications/hypersensitivity to P histicola or any of the capsule excipients 2. Patients with chronic hypoxia or underlying significant chronic respiratory disease (such as Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Fibrosis, or Bronchiectasis). 3. Admission to ICU at time of screening. 4. Mechanically ventilated, on continuous positive airway pressure (CPAP), or on non-invasive ventilation at the time of screening. 5. Patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin, or tacrolimus, unless these are given as part of COVID standard of care treatment. 6. Patient has a diagnosed primary immunodeficiency. 7. Patient has a diagnosis of HIV/AIDS 8. Patient has pre-existing known chronic kidney disease stage 4 or 5 or requiring renal replacement therapy (i.e. estimated glomerular filtration rate (eGFR) \<30ml/min/1.73m2) 9. Patient has pre-existing known significant liver disease with Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5.0 x upper limit of normal (ULN) 10. Patient has pre-existing known significant gastrointestinal tract disease expected to affect absorption within the small intestine (e.g. short bowel syndrome, inflammatory bowel disease affecting the small intestine, gastroparesis); or prior malabsorptive bariatric surgery that could interfere with GI delivery and transit time. 11. GI signs or symptoms equivalent to CTCAE v5.0, gastrointestinal disorders, grade 3 or 4 event. 12. Patient has pre-existing known substantially impaired cardiac function or pre-existing clinically significant cardiac diseases, including unstable angina or acute myocardial infarction ≤ 6 weeks prior to Screening. 13. Currently participating in an interventional clinical trial (observational studies allowed). 14. Moribund at time of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14 | 14 days | Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) \[S/F ratio\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in S/F Ratio | 14 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage change in S/F ratio at days 4, 7, 10 and 14/discharge day. |
| Percentage of Participants at Each Level on the WHO OSCI Score | 42 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants at each level on the WHO OSCI score at days 4, 7, 14, 21 and 42. (WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=unifected - 8=death) |
| Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | 42 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants with shifts from each level of the WHO OSCI score at baseline at days 4, 7, 14, 21 and 42. (WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death) |
| Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) | 42 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants remaining at their baseline score on the WHO OSCI (or lower) at days 4, 7, 14, 21 and 42. Once a participant has increased their WHO OSCI score they are not considered to have remained at or below their baseline value at future visits regardless of whether their score returns to or below their baseline value. (WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death) |
| Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | 42 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day. (WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death) |
| The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | 42 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the time in days spent at each participant's worst reported WHO OSCI score (excluding death). |
| Intubation and Mechanical-ventilation Free Survival | 42 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the intubation and mechanical-ventilation free survival, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 6 or more. (WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death) |
| Overall Survival | 42 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using overall survival, defined as the time in days from start of treatment to death by any cause |
| Change in S/F Ratio | 14 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using change in S/F ratio at days 4, 7, 10 and 14/discharge day. |
| Number of Days With Pyrexia | 42 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days with pyrexia ≥ 38C |
| Maximum Daily Temperature | 42 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature |
| SpO2 Level | 42 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels |
| Time to Discharge | 42 days | The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to discharge, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 2 or less. |
| Time to Oxygen Saturation (SpO2) ≥94% | 42 days | The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to oxygen saturation (SpO2) ≥94% on room air without further requirement for oxygen therapy. |
| Time to Recovery | 42 days | The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to recovery, defined as the time in days from symptom onset to alleviation of all COVID-19 symptoms. |
| Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | 42 days | The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by relationship to treatment |
| Incidence of Clinically Significant Abnormal Lab Parameters | 42 days | The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing clinically significant abnormal changes in safety lab parameters |
| Number of Days Requiring Oxygen Therapy | 42 days | The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days requiring oxygen therapy |
Countries
Turkey (Türkiye), United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients will receive placebo in addition to standard of care
Placebo: Placebo oral capsule | 7 |
| EDP1815 Patients will receive EDP1815 in addition to standard of care
EDP1815: EDP1815 is an orally administered monoclonal microbe | 9 |
| Total | 16 |
Baseline characteristics
| Characteristic | Placebo | EDP1815 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 8 Participants | 14 Participants |
| Region of Enrollment United States | 7 participants | 9 participants | 16 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 9 |
| other Total, other adverse events | 0 / 7 | 4 / 9 |
| serious Total, serious adverse events | 0 / 7 | 1 / 9 |
Outcome results
Primary
Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14
Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) \[S/F ratio\]
Time frame: 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14 | -30.0 Ratio | Standard Deviation 114.95 |
| EDP1815 | Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14 | -63.8 Ratio | Standard Deviation 76.85 |
Secondary
Change in S/F Ratio
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using change in S/F ratio at days 4, 7, 10 and 14/discharge day.
Time frame: 14 days
Population: All participants providing data at the relevant timepoints.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Change in S/F Ratio | Day 4 | 37.4 Ratio |
| Placebo | Change in S/F Ratio | Day 10 | 37.0 Ratio |
| Placebo | Change in S/F Ratio | Day 7 | -16.0 Ratio |
| Placebo | Change in S/F Ratio | Day 14 | -83.0 Ratio |
| EDP1815 | Change in S/F Ratio | Day 7 | -86.7 Ratio |
| EDP1815 | Change in S/F Ratio | Day 4 | -23.0 Ratio |
| EDP1815 | Change in S/F Ratio | Day 14 | -14.0 Ratio |
| EDP1815 | Change in S/F Ratio | Day 10 | -111.0 Ratio |
Secondary
Incidence of Clinically Significant Abnormal Lab Parameters
The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing clinically significant abnormal changes in safety lab parameters
Time frame: 42 days
Population: Any clinically significant abnormal lab parameters were included as AEs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Incidence of Clinically Significant Abnormal Lab Parameters | 0 number of participants |
| EDP1815 | Incidence of Clinically Significant Abnormal Lab Parameters | 0 number of participants |
Secondary
Intubation and Mechanical-ventilation Free Survival
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the intubation and mechanical-ventilation free survival, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 6 or more. (WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Time frame: 42 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Intubation and Mechanical-ventilation Free Survival | Number of pts who died or required intubation/mechanical ventilation | 0 Participants |
| Placebo | Intubation and Mechanical-ventilation Free Survival | Number of participants censored | 7 Participants |
| EDP1815 | Intubation and Mechanical-ventilation Free Survival | Number of pts who died or required intubation/mechanical ventilation | 1 Participants |
| EDP1815 | Intubation and Mechanical-ventilation Free Survival | Number of participants censored | 8 Participants |
Secondary
Maximum Daily Temperature
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature
Time frame: 42 days
Population: All participants providing data within the relevant interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Maximum Daily Temperature | Days 1-42 | 37.21 degress c | Standard Deviation 0.414 |
| Placebo | Maximum Daily Temperature | Days 1-14 | 37.21 degress c | Standard Deviation 0.414 |
| Placebo | Maximum Daily Temperature | Days 1-28 | 37.21 degress c | Standard Deviation 0.414 |
| EDP1815 | Maximum Daily Temperature | Days 1-42 | 37.32 degress c | Standard Deviation 0.854 |
| EDP1815 | Maximum Daily Temperature | Days 1-28 | 37.32 degress c | Standard Deviation 0.854 |
| EDP1815 | Maximum Daily Temperature | Days 1-14 | 37.32 degress c | Standard Deviation 0.854 |
Secondary
Number of Days Requiring Oxygen Therapy
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days requiring oxygen therapy
Time frame: 42 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Days Requiring Oxygen Therapy | Days 1-14 | 6.9 days | Standard Deviation 5.01 |
| Placebo | Number of Days Requiring Oxygen Therapy | Days 1-28 | 8.9 days | Standard Deviation 9.3 |
| Placebo | Number of Days Requiring Oxygen Therapy | Days 1-42 | 10.9 days | Standard Deviation 14.28 |
| EDP1815 | Number of Days Requiring Oxygen Therapy | Days 1-14 | 6.8 days | Standard Deviation 4.52 |
| EDP1815 | Number of Days Requiring Oxygen Therapy | Days 1-28 | 8.8 days | Standard Deviation 8.66 |
| EDP1815 | Number of Days Requiring Oxygen Therapy | Days 1-42 | 9 days | Standard Deviation 9.22 |
Secondary
Number of Days With Pyrexia
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days with pyrexia ≥ 38C
Time frame: 42 days
Population: All participants providing data within the relevant interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Days With Pyrexia | Days 1-14 | 0.1 Days | Standard Deviation 0.38 |
| Placebo | Number of Days With Pyrexia | Days 1-28 | 0.1 Days | Standard Deviation 0.38 |
| Placebo | Number of Days With Pyrexia | Days 1-42 | 0.1 Days | Standard Deviation 0.38 |
| EDP1815 | Number of Days With Pyrexia | Days 1-14 | 0.4 Days | Standard Deviation 0.73 |
| EDP1815 | Number of Days With Pyrexia | Days 1-28 | 0.4 Days | Standard Deviation 0.73 |
| EDP1815 | Number of Days With Pyrexia | Days 1-42 | 0.4 Days | Standard Deviation 0.73 |
Secondary
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness
Time frame: 42 days
Population: Only serious AEs, AEs of CTCAE Grade 3 or above and AEs of special interest (all CTCAE grades) were documented and included in the summary.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Acute Respiratory Distress Syndrome | 0 Participants |
| Placebo | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Diarrhoea | 0 Participants |
| Placebo | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Abdominal distension | 0 Participants |
| Placebo | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Hypertension | 0 Participants |
| EDP1815 | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Hypertension | 0 Participants |
| EDP1815 | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Acute Respiratory Distress Syndrome | 0 Participants |
| EDP1815 | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Abdominal distension | 0 Participants |
| EDP1815 | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Diarrhoea | 0 Participants |
Secondary
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by relationship to treatment
Time frame: 42 days
Population: The numbers analyzed only includes those participants who experienced adverse events.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Acute Respiratory Distress Syndrome : Not related | 0 Participants |
| Placebo | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Acute Respiratory Distress Syndrome : Related | 0 Participants |
| Placebo | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Diarrhoea : Not related | 0 Participants |
| Placebo | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Diarrhoea : Related | 0 Participants |
| Placebo | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Abdominal distension : Not related | 0 Participants |
| Placebo | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Abdominal distension : Related | 0 Participants |
| Placebo | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Hypertension : Not related | 0 Participants |
| Placebo | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Hypertension : Related | 0 Participants |
| EDP1815 | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Hypertension : Related | 0 Participants |
| EDP1815 | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Acute Respiratory Distress Syndrome : Not related | 1 Participants |
| EDP1815 | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Abdominal distension : Not related | 1 Participants |
| EDP1815 | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Acute Respiratory Distress Syndrome : Related | 0 Participants |
| EDP1815 | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Hypertension : Not related | 2 Participants |
| EDP1815 | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Diarrhoea : Not related | 1 Participants |
| EDP1815 | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Abdominal distension : Related | 0 Participants |
| EDP1815 | Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment | Diarrhoea : Related | 0 Participants |
Secondary
Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants remaining at their baseline score on the WHO OSCI (or lower) at days 4, 7, 14, 21 and 42. Once a participant has increased their WHO OSCI score they are not considered to have remained at or below their baseline value at future visits regardless of whether their score returns to or below their baseline value. (WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Time frame: 42 days
Population: All participants providing data at the relevant timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) | Day 7 | 6 Participants |
| Placebo | Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) | Day 21 | 5 Participants |
| Placebo | Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) | Day 14 | 5 Participants |
| Placebo | Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) | Day 42 | 4 Participants |
| Placebo | Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) | Day 4 | 7 Participants |
| EDP1815 | Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) | Day 42 | 3 Participants |
| EDP1815 | Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) | Day 4 | 7 Participants |
| EDP1815 | Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) | Day 7 | 3 Participants |
| EDP1815 | Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) | Day 14 | 4 Participants |
| EDP1815 | Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) | Day 21 | 4 Participants |
Secondary
Overall Survival
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using overall survival, defined as the time in days from start of treatment to death by any cause
Time frame: 42 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Overall Survival | Number of participants who died | 0 Participants |
| Placebo | Overall Survival | Number of participants censored | 7 Participants |
| EDP1815 | Overall Survival | Number of participants who died | 0 Participants |
| EDP1815 | Overall Survival | Number of participants censored | 9 Participants |
Secondary
Percentage Change in S/F Ratio
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage change in S/F ratio at days 4, 7, 10 and 14/discharge day.
Time frame: 14 days
Population: All participants providing data at the relevant timepoints.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Percentage Change in S/F Ratio | Day 4 | 10.97 percentage change |
| Placebo | Percentage Change in S/F Ratio | Day 7 | -10.41 percentage change |
| Placebo | Percentage Change in S/F Ratio | Day 10 | 109.7 percentage change |
| Placebo | Percentage Change in S/F Ratio | Day 14 | -46.6 percentage change |
| EDP1815 | Percentage Change in S/F Ratio | Day 14 | -5.7 percentage change |
| EDP1815 | Percentage Change in S/F Ratio | Day 4 | -5.33 percentage change |
| EDP1815 | Percentage Change in S/F Ratio | Day 10 | -46.6 percentage change |
| EDP1815 | Percentage Change in S/F Ratio | Day 7 | -36.48 percentage change |
Secondary
Percentage of Participants at Each Level on the WHO OSCI Score
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants at each level on the WHO OSCI score at days 4, 7, 14, 21 and 42. (WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=unifected - 8=death)
Time frame: 42 days
Population: All participants providing data at the relevant timepoints.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 0 | 1 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 1 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 2 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 3 | 1 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 4 | 5 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 5 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 6 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 7 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 8 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 0 | 1 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 1 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 2 | 3 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 3 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 4 | 2 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 5 | 1 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 6 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 7 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 8 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 0 | 3 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 1 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 2 | 2 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 3 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 4 | 1 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 5 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 6 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 7 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 8 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 0 | 4 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 1 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 2 | 1 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 3 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 4 | 1 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 5 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 6 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 7 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 8 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 0 | 4 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 1 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 2 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 3 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 4 | 1 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 5 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 6 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 7 | 0 Participants |
| Placebo | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 4 | 1 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 0 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 5 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 2 | 1 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 3 | 1 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 6 | 1 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 4 | 5 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 6 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 5 | 1 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 6 | 1 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 4 | WHO OSCI score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 4 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 0 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 0 | 1 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 0 | 3 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 2 | 2 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 4 | 1 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 2 | 4 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 5 | 1 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 6 | 1 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 5 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 7 | WHO OSCI score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 4 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 0 | 1 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 2 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 5 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 2 | 3 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 42 | WHO OSCI score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 14 | WHO OSCI score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants at Each Level on the WHO OSCI Score | Day 21 | WHO OSCI score - 6 | 1 Participants |
Secondary
Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day. (WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Time frame: 42 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | Score = 3 | 1 Participants |
| Placebo | Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | Score = 4 | 4 Participants |
| Placebo | Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | Score = 5 | 2 Participants |
| Placebo | Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | Score = 6 | 0 Participants |
| Placebo | Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | Score = 7 | 0 Participants |
| Placebo | Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | Score = 8 | 0 Participants |
| EDP1815 | Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | Score = 7 | 0 Participants |
| EDP1815 | Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | Score = 3 | 0 Participants |
| EDP1815 | Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | Score = 6 | 1 Participants |
| EDP1815 | Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | Score = 4 | 7 Participants |
| EDP1815 | Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | Score = 8 | 0 Participants |
| EDP1815 | Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day | Score = 5 | 1 Participants |
Secondary
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants with shifts from each level of the WHO OSCI score at baseline at days 4, 7, 14, 21 and 42. (WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Time frame: 42 days
Population: All participants providing data at the relevant timepoints.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 8 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 5 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 6 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 7 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 8 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 0 | 4 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 1 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 2 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 3 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 4 | 1 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 5 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 6 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 7 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 8 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 0 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 1 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 2 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 3 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 4 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 5 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 6 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 7 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 4 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 0 | 1 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 1 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 2 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 3 | 1 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 4 | 4 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 5 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 6 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 7 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 8 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 0 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 1 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 2 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 3 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 4 | 1 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 5 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 6 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 7 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 8 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 0 | 1 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 1 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 2 | 3 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 3 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 4 | 1 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 5 | 1 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 6 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 7 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 8 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 0 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 1 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 2 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 3 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 4 | 1 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 5 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 6 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 7 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 8 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 0 | 3 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 1 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 2 | 2 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 3 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 4 | 1 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 5 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 6 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 7 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 8 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 0 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 1 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 2 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 3 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 4 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 5 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 6 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 7 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 8 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 0 | 4 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 1 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 2 | 1 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 3 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 4 | 1 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 5 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 6 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 7 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 8 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 0 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 1 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 2 | 0 Participants |
| Placebo | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 4 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 4 | 1 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 5 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 6 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 5 | 1 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 0 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 6 | 1 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 0 | 3 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 2 | 4 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 2 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 4 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 5 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 0 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 6 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 2 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 4; WHO OSCI Score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 0 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 2 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 2 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 4 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 4 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 5 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 4 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 6 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 5 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 4 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 42 | Baseline WHO OSCI score 5; WHO OSCI Score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 6 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 0 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 5 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 2 | 1 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 3 | 1 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 5; WHO OSCI Score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 4 | 5 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 6 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 5 | 1 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 0 | 1 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 6 | 1 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 5 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 4; WHO OSCI Score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 0 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 2 | 3 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 0 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 2 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 3 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 5; WHO OSCI Score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 4 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 4 | 1 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 5 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 6 | 1 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 6 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 5 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 0 | 1 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 4 | Baseline WHO OSCI score 5; WHO OSCI Score - 8 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 6 | 1 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 0 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 5; WHO OSCI Score - 2 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 14 | Baseline WHO OSCI score 4; WHO OSCI Score - 7 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 2 | 2 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day 21 | Baseline WHO OSCI score 4; WHO OSCI Score - 1 | 0 Participants |
| EDP1815 | Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline | Day7 | Baseline WHO OSCI score 4; WHO OSCI Score - 3 | 0 Participants |
Secondary
SpO2 Level
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels
Time frame: 42 days
Population: All participants providing data within the relevant interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | SpO2 Level | Days 1-7 (min) | 92.3 percentage of oxygen saturation | Standard Deviation 2.43 |
| Placebo | SpO2 Level | Days 1-7 (max) | 96.0 percentage of oxygen saturation | Standard Deviation 1.83 |
| Placebo | SpO2 Level | Days 1-14 (min) | 92.0 percentage of oxygen saturation | Standard Deviation 2.71 |
| Placebo | SpO2 Level | Days 1-14 (max) | 96.0 percentage of oxygen saturation | Standard Deviation 1.83 |
| Placebo | SpO2 Level | Days 1-28 (min) | 92.0 percentage of oxygen saturation | Standard Deviation 2.71 |
| Placebo | SpO2 Level | Days 1-28 (max) | 96.0 percentage of oxygen saturation | Standard Deviation 1.83 |
| Placebo | SpO2 Level | Days 1-42 (min) | 92.0 percentage of oxygen saturation | Standard Deviation 2.71 |
| Placebo | SpO2 Level | Days 1-42 (max) | 96.6 percentage of oxygen saturation | Standard Deviation 2.07 |
| EDP1815 | SpO2 Level | Days 1-42 (max) | 97.1 percentage of oxygen saturation | Standard Deviation 2.37 |
| EDP1815 | SpO2 Level | Days 1-7 (min) | 91.7 percentage of oxygen saturation | Standard Deviation 2.18 |
| EDP1815 | SpO2 Level | Days 1-28 (min) | 91.7 percentage of oxygen saturation | Standard Deviation 2.18 |
| EDP1815 | SpO2 Level | Days 1-7 (max) | 96.7 percentage of oxygen saturation | Standard Deviation 2.5 |
| EDP1815 | SpO2 Level | Days 1-42 (min) | 91.7 percentage of oxygen saturation | Standard Deviation 2.18 |
| EDP1815 | SpO2 Level | Days 1-14 (min) | 91.7 percentage of oxygen saturation | Standard Deviation 2.18 |
| EDP1815 | SpO2 Level | Days 1-28 (max) | 97.1 percentage of oxygen saturation | Standard Deviation 2.37 |
| EDP1815 | SpO2 Level | Days 1-14 (max) | 97.1 percentage of oxygen saturation | Standard Deviation 2.37 |
Secondary
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death).
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the time in days spent at each participant's worst reported WHO OSCI score (excluding death).
Time frame: 42 days
Population: All participants providing data at the relevant timepoints.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 4; 1 day | 0 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 5; 2-3 days | 1 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 3; 4-7 days | 0 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 5; 4-7 days | 1 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 4; 2-3 days | 2 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 5; >7days | 0 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 3; 2-3 days | 0 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 6; 1 days | 0 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 4; 4-7 days | 2 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 6; 2-3 days | 0 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 3; >7 days | 0 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 6; 4-7 days | 0 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 4; >7 days | 0 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 6; >7 days | 0 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 7 | 0 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 3; 1 day | 1 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 8 | 0 Participants |
| Placebo | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 5: 1 day | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 8 | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 3; 1 day | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 3; 2-3 days | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 3; 4-7 days | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 3; >7 days | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 4; 1 day | 2 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 4; 2-3 days | 3 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 4; 4-7 days | 1 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 4; >7 days | 1 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 5: 1 day | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 5; 2-3 days | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 5; 4-7 days | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 5; >7days | 1 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 6; 1 days | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 6; 2-3 days | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 6; 4-7 days | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 7 | 0 Participants |
| EDP1815 | The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). | Score = 6; >7 days | 1 Participants |
Secondary
Time to Discharge
The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to discharge, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 2 or less.
Time frame: 42 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Time to Discharge | Number of participants discharged | 6 Participants |
| Placebo | Time to Discharge | Number of participants who died | 0 Participants |
| Placebo | Time to Discharge | Number of participants censored | 1 Participants |
| EDP1815 | Time to Discharge | Number of participants who died | 0 Participants |
| EDP1815 | Time to Discharge | Number of participants discharged | 6 Participants |
| EDP1815 | Time to Discharge | Number of participants censored | 3 Participants |
Secondary
Time to Oxygen Saturation (SpO2) ≥94%
The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to oxygen saturation (SpO2) ≥94% on room air without further requirement for oxygen therapy.
Time frame: 42 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Time to Oxygen Saturation (SpO2) ≥94% | Number of participants who achieved SpO2 >=94% without further requirement for oxygen therapy | 6 Participants |
| Placebo | Time to Oxygen Saturation (SpO2) ≥94% | Number of participants who died | 0 Participants |
| Placebo | Time to Oxygen Saturation (SpO2) ≥94% | Number of participants censored | 1 Participants |
| EDP1815 | Time to Oxygen Saturation (SpO2) ≥94% | Number of participants who achieved SpO2 >=94% without further requirement for oxygen therapy | 6 Participants |
| EDP1815 | Time to Oxygen Saturation (SpO2) ≥94% | Number of participants who died | 0 Participants |
| EDP1815 | Time to Oxygen Saturation (SpO2) ≥94% | Number of participants censored | 3 Participants |
Secondary
Time to Recovery
The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to recovery, defined as the time in days from symptom onset to alleviation of all COVID-19 symptoms.
Time frame: 42 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Time to Recovery | Number of participants who recovered | 4 Participants |
| Placebo | Time to Recovery | Number of participants who died | 0 Participants |
| Placebo | Time to Recovery | Number of participants censored | 3 Participants |
| EDP1815 | Time to Recovery | Number of participants who recovered | 4 Participants |
| EDP1815 | Time to Recovery | Number of participants who died | 0 Participants |
| EDP1815 | Time to Recovery | Number of participants censored | 5 Participants |