COVID-19
Conditions
Brief summary
The purpose of this trial is to assess the safety, tolerability and treatment effect of the orally administered Caspase-1 inhibitor, belnacasan, for the treatment of patients with mild to moderate COVID-19 and to generate proof of concept for future trials.
Detailed description
COVID-19 is an acute respiratory disease caused by the SARS-CoV-2 virus which has impacted the lives of millions of patients. Though vaccines and preventive treatments such as monoclonal antibodies, steroids, and anti-virals have been established, they do not specifically target the resulting inflammatory response and complications the virus causes. This study aims to evaluate how safe and effective a particular oral medication, Belnacasan, is in diminishing your body's inflammatory response, which may go into overdrive when infected with the virus. This overly activated immune response can become uncontrolled resulting in cell death and the release of damaging proteins which can cause major harm to all organs throughout the body. Belnacasan prevents the activation of a particular enzyme, Caspase-1, which plays a major role in activating this damaging immune response brought on by COVID-19. The goal of this medication being a more targeted treatment that aims to prevent the devastating immune response.
Interventions
DRUGBelnacasan
Oral administration
DRUGPlacebo
Tablet containing 0mg of API
Sponsors
MedStar Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomizations, assigned 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject (or legally authorized representative) provides written informed consent prior to the initiation of any study procedures 2. Subject understands and agrees to comply with planned study procedures, including using the diary 3. Subject agrees to the collection of nasopharyngeal swabs and venous blood per protocol 4. Subject is male or non-pregnant female adult ≥18 years of age at time of consent a. Women with a history of menstruation must agree to use two methods of contraception, at least one of which is highly effective, for the duration of the study as well as to undergo additional pregnancy testing during the study 5. Subject has a laboratory confirmed SARS-CoV-2 infection as determined by RT-PCR assay prior to enrollment 6. Subject has evidence of either mild or moderate COVID-19 illness of less than 7 days from first onset, with minimal baseline symptom severity based on patient-reported FDA scoring system defined as follows: 1. Subject presents with at least two common symptoms of COVID-19 from the following list: Stuffy or runny nose, sore throat, cough, low energy or tiredness, muscle or body ache, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, shortness of breath with exertion (without supplemental oxygen requirement) with a score of 2 or higher, impairment in sense of smell or taste with a score of 1 or higher OR 2. Subject presents with any (i.e., at least one) symptom of COVID-19 as defined above AND clinical evidence of moderate COVID-19 as defined by FDA guidance for industry (such as respiratory rate \>20 breaths per minute, heart rate \>90 beats per minute, with oxygen saturation \>93% on room air at sea level) 7. Subject presents with high-risk for COVID-19-related inflammation determined by at least one comorbidity, including obesity, diabetes, hypertension, stable heart disease, respiratory disease, and/or non-severe fatty liver disease 8. Subject's overall health condition is deemed as suitable to fully and safely participate in this trial as determined by the investigator
Exclusion criteria
1. Any clinical signs indicative of severe or critical COVID-19 as defined by FDA guidance for Industry at the time, including SpO2 \<93% and/or oxygen requirement 2. Hospitalization for COVID-19, or consideration thereof 3. ICU level of care and/or non-mechanical/mechanical ventilation and/or oxygen supplementation at time of enrollment 4. Pregnant or breast-feeding subjects 5. Subjects who cannot swallow tablets 6. History of any pre-existing organ impairment, such as: 1. Severe kidney disease (known or estimated GFR \<30 mL/minute) or on dialysis 2. Uncontrolled, clinically significant heart diseases such as arrhythmias, angina or heart failure as defined by AHA/ACC Grade C and D 3. Chronic respiratory disease requiring supplemental oxygen 4. Moderate and severe hepatic impairment as defined by Child-Pugh scoring Class B and Class C 7. Elevated liver function test (determined by ALT, AST, GGT, or ALP \>2x upper limit of normal, and/or total Bilirubin \> upper limit of normal) 8. History of malignancy or immunodeficiency within the prior 5 years 9. Acute respiratory illness other than COVID-19 10. Acute bacterial, viral or fungal infection (including HIV, hepatitis B, hepatitis C) 11. While dosed with IP, the taking of prohibited concomitant medication or the ingestion of food that interferes with the IP, including: 1. Non-COVID19-related anti-viral medication such as lopinavir, ritonavir, ribavirin, or interferon-1β 2. Systemically administered immunosuppressive and anti-inflammatory agents, other than background standard of care for COVID-19 at the time 3. Drugs and foods that are potent inhibitors or inducers of CYP3A4 and/or P-gp, as listed in FDA Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers, including herbal medications such as St. John's Wort within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug 12. Any other diseases or medical conditions or concomitant medications that are deemed as not compatible or appropriate for the subject's ability to fully and safely participate in this trial as determined by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Belnacasan | Through 60 days post enrollment | Number of adverse events and serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| G-CSF | Baseline and Days 7, 14, 21, and 28 | Plasma levels of G-CSF |
| Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Baseline and Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization | Proportion of subjects in treatment group versus placebo group, respectively, who, per symptom questionnaire, rate stuffy or runny nose, sore throat, cough, low energy or tiredness, muscle or body ache, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, shortness of breath at rest, shortness of breath with exertion, or impairment in sense of smell or taste as mild, moderate or severe. |
| Oxygenation Levels | Over 60 days post randomization | Average change from baseline over 60 days in percentage of blood saturation |
| Sustained Improvement of Global Impression Rates | Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization | Proportion of subjects in treatment group versus placebo group, respectively, who per symptom questionnaire have answered for two consecutive days: YES to In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)?; YES to In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)? |
| Time to Sustained Recovery or Resolution of Common COVID-19 Symptoms | Over 60 days post randomization | Comparison in treatment group versus placebo group, respectively, of the number of days from randomization to the first day of achieving sustained recovery and resolution rates of common COVID-19 symptoms. |
| Time to Sustained Improvement of Global Impression | Over 60 days post randomization | Comparison in treatment group versus placebo group, respectively, of the mean number of days from randomization to the first day of achieving sustained improvement of global impression rates. |
| Rates of Fever | Days between enrollment and day 2 post randomization | Proportion of subjects in treatment group versus placebo group, respectively, who, per thermometer, experienced fever at any point between enrollment and day 2 post randomization. |
| Time in Days to Normalization of Fever and Oxygenation Levels. | 28 Days | Comparison in treatment group versus placebo group, respectively, of the number of days from randomization to the first day of achieving sustained (i.e., at least 2 days) resolution of fever for subjects who presented with fever at any point between enrollment and day 2 post randomization; with temperature \<38C or \>=38C experienced in total during the first 28 days post randomization; from randomization to the first day post randomization of achieving oxygenation of SpO2\>=96% in room air when resting for subjects who presented with SpO2\>93% and \<96% in room air, when resting, at enrollment; with oxygenation of SpO2\>= 96% or SpO2\>93% in room air, when resting, in total during the first 28 days post randomization. |
| Experiences of COVID-19 Related Deterioration and Mortality | Days 14, 28 and 60 post randomization | Proportion of treatment group, versus placebo group, respectively, who per subject reporting or medical records had experienced an emergency department visit, other than at study enrollment or study visits; hospitalization for COVID-19; hospitalization for COVID-19 requiring oxygen; hospitalization for COVID-19 requiring ICU; hospitalization for COVID-19 requiring ventilation; COVID-19 related death; death; hospitalization or death on Days 14, 28, and 60. |
| TNF-alpha | Baseline and Days 7, 14, 21, and 28 | Plasma levels of TNF-alpha |
| Caspase-1 | Baseline and Days 7, 14, 21, and 28 | Plasma levels of caspase-1 |
| The Number of Subjects With COVID-19 Related Deterioration and Mortality Experiences | Over 28 days | Comparison of treatment group versus placebo group, respectively, in the number of subjects who following randomization experienced hospitalization for COVID-19 related deterioration: requiring oxygen, requiring ICU admission, requiring ventilation. |
| Changes on the WHO 9-Point Ordinal Scale | Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization | The counts of participants in the treatment group versus placebo group, respectively, who per questionnaire on WHO 9-point ordinal scale \[0: Uninfected or no clinical or virological evidence of infection; 1: Not hospitalized, no limitations on activities; 2: Not hospitalized, limitation on activities; 3: Hospitalized, not requiring supplemental oxygen; 4: Hospitalized, requiring supplemental oxygen; 5: Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6: Hospitalized, intubated; 7: Hospitalized, advanced life support including invasive mechanical ventilation or ECMO; 8: Death\] had experienced an improvement from scale 2 to scale 1 or 0; an improvement from scale 1 to scale 0 ; a sustainment from scale 1 to scale 1; any improvement of the scale; any worsening of the scale; scale 4 or higher; scale 6 or higher. |
| Gasdermin D | Baseline and Days 7, 14, 21, and 28 | Plasma levels of gasdermin D |
| Values on the WHO 9-Point Ordinal Scale | Days 14, 28, and 60 post randomization | Comparison of treatment group versus placebo group, respectively, in the average of daily scale value (0-8) on Days 14, 28, and 60 with respect to the number of subjects who reported as uninfected (scale value of 0), had no limitations (scale value of 1), or were experiencing limitations (scale value of 2). All patients had a score ranging between 0-2. A description of the WHO 9-Point Ordinal Scale follows: 0\. Uninfected or no clinical or virological evidence of infection * defined as subject answering Yes to In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? 1\. Not hospitalized, no limitations on activities * defined as subject answering Yes to In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)? 2. Not hospitalized, limitation on activities * defined as subject answering No to In the past 24 hours, have you returned to your usual act |
| Time to Improvement on the WHO 9-Point Ordinal Scale | Post treatment to Day 60 | Comparison of treatment group versus placebo group, respectively, in the mean number of days from enrollment to reporting no limitations or uninfected. The discrepancy in patient numbers (enrolled versus analyzed) is due to patients who either dropped out or have missing data. |
| Mean Number of Days of Experiencing WHO 9-Point Ordinal Scale Values | Post treatment through Day 60 | Comparison of treatment group versus placebo group, respectively, in the mean number of days on which subjects experienced limitations, no limitations, and uninfected post treatment (60 Days). |
| IL-6 | Baseline and Days 7, 14, 21, 28 | Plasma levels of IL-6 |
| IL-1ra | Baseline and Days 7, 14, 21, 28 | Measurement of plasma IL-1ra levels |
| IL-18 | Baseline and Days 7, 14, 21, and 28 | Measurement of plasma levels of IL-18 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interventional 900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration | 20 |
| Placebo 0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Interventional | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 11.9 | 41.6 years STANDARD_DEVIATION 12.1 | 43.4 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 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 | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) White | 13 Participants | 11 Participants | 24 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 2 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Safety and Tolerability of Belnacasan
Number of adverse events and serious adverse events
Time frame: Through 60 days post enrollment
Population: Patients reporting AEs and SAEs from the time of enrollment through Day 60
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interventional | Safety and Tolerability of Belnacasan | Number of adverse events | 11 Number of AEs and SAEs |
| Interventional | Safety and Tolerability of Belnacasan | Number of serious adverse events | 0 Number of AEs and SAEs |
| Placebo | Safety and Tolerability of Belnacasan | Number of adverse events | 10 Number of AEs and SAEs |
| Placebo | Safety and Tolerability of Belnacasan | Number of serious adverse events | 0 Number of AEs and SAEs |
Secondary
Caspase-1
Plasma levels of caspase-1
Time frame: Baseline and Days 7, 14, 21, and 28
Population: Number of patients who had plasma caspase-1 levels measured Baseline and Days 7, 14, 21, 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | Caspase-1 | Day 7 | 84.7 pg/mL | Standard Deviation 95.2 |
| Interventional | Caspase-1 | Day 21 | 98.7 pg/mL | Standard Deviation 120 |
| Interventional | Caspase-1 | Day 14 | 69.5 pg/mL | Standard Deviation 74.8 |
| Interventional | Caspase-1 | Day 28 | 101.6 pg/mL | Standard Deviation 150.9 |
| Interventional | Caspase-1 | Baseline | 97.2 pg/mL | Standard Deviation 77.6 |
| Placebo | Caspase-1 | Day 28 | 83.4 pg/mL | Standard Deviation 66.4 |
| Placebo | Caspase-1 | Baseline | 115.5 pg/mL | Standard Deviation 110 |
| Placebo | Caspase-1 | Day 7 | 104.4 pg/mL | Standard Deviation 92 |
| Placebo | Caspase-1 | Day 14 | 96.4 pg/mL | Standard Deviation 105.8 |
| Placebo | Caspase-1 | Day 21 | 96.4 pg/mL | Standard Deviation 105.8 |
Secondary
Changes on the WHO 9-Point Ordinal Scale
The counts of participants in the treatment group versus placebo group, respectively, who per questionnaire on WHO 9-point ordinal scale \[0: Uninfected or no clinical or virological evidence of infection; 1: Not hospitalized, no limitations on activities; 2: Not hospitalized, limitation on activities; 3: Hospitalized, not requiring supplemental oxygen; 4: Hospitalized, requiring supplemental oxygen; 5: Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6: Hospitalized, intubated; 7: Hospitalized, advanced life support including invasive mechanical ventilation or ECMO; 8: Death\] had experienced an improvement from scale 2 to scale 1 or 0; an improvement from scale 1 to scale 0 ; a sustainment from scale 1 to scale 1; any improvement of the scale; any worsening of the scale; scale 4 or higher; scale 6 or higher.
Time frame: Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization
Population: Patients reported WHO 9-point scale status from baseline to scale 1 or 0 at Days 4, 7, 10, 14, 21, 28, 42, and 60
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional | Changes on the WHO 9-Point Ordinal Scale | Day 21 | 15 Participants |
| Interventional | Changes on the WHO 9-Point Ordinal Scale | Day 42 | 16 Participants |
| Interventional | Changes on the WHO 9-Point Ordinal Scale | Day 4 | 3 Participants |
| Interventional | Changes on the WHO 9-Point Ordinal Scale | Day 7 | 8 Participants |
| Interventional | Changes on the WHO 9-Point Ordinal Scale | Day 10 | 14 Participants |
| Interventional | Changes on the WHO 9-Point Ordinal Scale | Day 14 | 14 Participants |
| Interventional | Changes on the WHO 9-Point Ordinal Scale | Day 28 | 16 Participants |
| Interventional | Changes on the WHO 9-Point Ordinal Scale | Day 60 | 17 Participants |
| Placebo | Changes on the WHO 9-Point Ordinal Scale | Day 42 | 16 Participants |
| Placebo | Changes on the WHO 9-Point Ordinal Scale | Day 14 | 11 Participants |
| Placebo | Changes on the WHO 9-Point Ordinal Scale | Day 21 | 15 Participants |
| Placebo | Changes on the WHO 9-Point Ordinal Scale | Day 4 | 6 Participants |
| Placebo | Changes on the WHO 9-Point Ordinal Scale | Day 60 | 15 Participants |
| Placebo | Changes on the WHO 9-Point Ordinal Scale | Day 7 | 8 Participants |
| Placebo | Changes on the WHO 9-Point Ordinal Scale | Day 28 | 16 Participants |
| Placebo | Changes on the WHO 9-Point Ordinal Scale | Day 10 | 13 Participants |
Secondary
Experiences of COVID-19 Related Deterioration and Mortality
Proportion of treatment group, versus placebo group, respectively, who per subject reporting or medical records had experienced an emergency department visit, other than at study enrollment or study visits; hospitalization for COVID-19; hospitalization for COVID-19 requiring oxygen; hospitalization for COVID-19 requiring ICU; hospitalization for COVID-19 requiring ventilation; COVID-19 related death; death; hospitalization or death on Days 14, 28, and 60.
Time frame: Days 14, 28 and 60 post randomization
Population: The number of treatment group, versus placebo group, respectively, who had COVID-related: emergency department visit, hospitalization, required oxygen, required an ICU visit, required ventilation, or died as of Days 14, 28, and 60.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interventional | Experiences of COVID-19 Related Deterioration and Mortality | Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 28 | 0 Number of subjects |
| Interventional | Experiences of COVID-19 Related Deterioration and Mortality | Subjects who required oxygen or ventilation by Day 14 | 0 Number of subjects |
| Interventional | Experiences of COVID-19 Related Deterioration and Mortality | Subjects who required oxygen or ventilation by Day 28 | 0 Number of subjects |
| Interventional | Experiences of COVID-19 Related Deterioration and Mortality | Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 14. | 0 Number of subjects |
| Interventional | Experiences of COVID-19 Related Deterioration and Mortality | Subjects who required oxygen or ventilation by Day 60 | 0 Number of subjects |
| Interventional | Experiences of COVID-19 Related Deterioration and Mortality | Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 60 | 0 Number of subjects |
| Placebo | Experiences of COVID-19 Related Deterioration and Mortality | Subjects who required oxygen or ventilation by Day 60 | 0 Number of subjects |
| Placebo | Experiences of COVID-19 Related Deterioration and Mortality | Subjects who required oxygen or ventilation by Day 14 | 0 Number of subjects |
| Placebo | Experiences of COVID-19 Related Deterioration and Mortality | Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 28 | 0 Number of subjects |
| Placebo | Experiences of COVID-19 Related Deterioration and Mortality | Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 60 | 0 Number of subjects |
| Placebo | Experiences of COVID-19 Related Deterioration and Mortality | Subjects who required oxygen or ventilation by Day 28 | 0 Number of subjects |
| Placebo | Experiences of COVID-19 Related Deterioration and Mortality | Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 14. | 0 Number of subjects |
Secondary
Gasdermin D
Plasma levels of gasdermin D
Time frame: Baseline and Days 7, 14, 21, and 28
Population: Number of patients who had plasma gasdermin D levels measured Baseline and Days 7, 14, 21, 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | Gasdermin D | Baseline | 2.5 pg/mL | Standard Deviation 1.9 |
| Interventional | Gasdermin D | Day 14 | 5.0 pg/mL | Standard Deviation 3.1 |
| Interventional | Gasdermin D | Day 28 | 5.4 pg/mL | Standard Deviation 3.3 |
| Interventional | Gasdermin D | Day 21 | 6.2 pg/mL | Standard Deviation 3.1 |
| Interventional | Gasdermin D | Day 7 | 4.0 pg/mL | Standard Deviation 2.5 |
| Placebo | Gasdermin D | Day 28 | 5.4 pg/mL | Standard Deviation 2.7 |
| Placebo | Gasdermin D | Baseline | 3.5 pg/mL | Standard Deviation 2.9 |
| Placebo | Gasdermin D | Day 7 | 4.9 pg/mL | Standard Deviation 4 |
| Placebo | Gasdermin D | Day 14 | 5.2 pg/mL | Standard Deviation 3.6 |
| Placebo | Gasdermin D | Day 21 | 7.2 pg/mL | Standard Deviation 4 |
Secondary
G-CSF
Plasma levels of G-CSF
Time frame: Baseline and Days 7, 14, 21, and 28
Population: Number of patients who had plasma G-CSF levels measured Baseline and Days 7, 14, 21, 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | G-CSF | Baseline | 137.2 pg/mL | Standard Deviation 34.2 |
| Interventional | G-CSF | Day 21 | 114.5 pg/mL | Standard Deviation 34.9 |
| Interventional | G-CSF | Day 14 | 121.4 pg/mL | Standard Deviation 41.2 |
| Interventional | G-CSF | Day 28 | 122.5 pg/mL | Standard Deviation 45.3 |
| Interventional | G-CSF | Day 7 | 125.0 pg/mL | Standard Deviation 29.1 |
| Placebo | G-CSF | Day 28 | 102.9 pg/mL | Standard Deviation 24.1 |
| Placebo | G-CSF | Baseline | 147.0 pg/mL | Standard Deviation 56.9 |
| Placebo | G-CSF | Day 7 | 106.6 pg/mL | Standard Deviation 36.4 |
| Placebo | G-CSF | Day 14 | 100.2 pg/mL | Standard Deviation 20.8 |
| Placebo | G-CSF | Day 21 | 103.8 pg/mL | Standard Deviation 21.3 |
Secondary
IL-18
Measurement of plasma levels of IL-18
Time frame: Baseline and Days 7, 14, 21, and 28
Population: Number of patients who had plasma IL-18 levels measured Baseline and Days 7, 14, 21, 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | IL-18 | Day 7 | 82.0 pg/mL | Standard Deviation 60.4 |
| Interventional | IL-18 | Day 21 | 75.1 pg/mL | Standard Deviation 58.9 |
| Interventional | IL-18 | Day 14 | 77.0 pg/mL | Standard Deviation 58.8 |
| Interventional | IL-18 | Day 28 | 73.7 pg/mL | Standard Deviation 56 |
| Interventional | IL-18 | Baseline | 120.1 pg/mL | Standard Deviation 69.6 |
| Placebo | IL-18 | Day 28 | 74.4 pg/mL | Standard Deviation 36.6 |
| Placebo | IL-18 | Baseline | 116.0 pg/mL | Standard Deviation 65.9 |
| Placebo | IL-18 | Day 7 | 88.6 pg/mL | Standard Deviation 47.6 |
| Placebo | IL-18 | Day 14 | 81.7 pg/mL | Standard Deviation 38.6 |
| Placebo | IL-18 | Day 21 | 80.7 pg/mL | Standard Deviation 43.6 |
Secondary
IL-1ra
Measurement of plasma IL-1ra levels
Time frame: Baseline and Days 7, 14, 21, 28
Population: Number of patients who had plasma IL-1ra levels measured Baseline and Days 7, 14, 21, 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | IL-1ra | Day 7 | 31.2 pg/mL | Standard Deviation 18.1 |
| Interventional | IL-1ra | Day 21 | 40.2 pg/mL | Standard Deviation 14.5 |
| Interventional | IL-1ra | Day 14 | 34.0 pg/mL | Standard Deviation 13.6 |
| Interventional | IL-1ra | Day 28 | 37.1 pg/mL | Standard Deviation 15.8 |
| Interventional | IL-1ra | Baseline | 37.2 pg/mL | Standard Deviation 19 |
| Placebo | IL-1ra | Day 28 | 25.4 pg/mL | Standard Deviation 7.6 |
| Placebo | IL-1ra | Baseline | 32.5 pg/mL | Standard Deviation 14.4 |
| Placebo | IL-1ra | Day 7 | 26.6 pg/mL | Standard Deviation 11.4 |
| Placebo | IL-1ra | Day 14 | 23.2 pg/mL | Standard Deviation 7.7 |
| Placebo | IL-1ra | Day 21 | 23.7 pg/mL | Standard Deviation 11.2 |
Secondary
IL-6
Plasma levels of IL-6
Time frame: Baseline and Days 7, 14, 21, 28
Population: Number of patients who had plasma IL-6 levels measured Baseline and Days 7, 14, 21, 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | IL-6 | Day 7 | 15.1 pg/mL | Standard Deviation 12.1 |
| Interventional | IL-6 | Day 21 | 16.0 pg/mL | Standard Deviation 15.1 |
| Interventional | IL-6 | Day 14 | 16.9 pg/mL | Standard Deviation 13.4 |
| Interventional | IL-6 | Day 28 | 13.9 pg/mL | Standard Deviation 10.8 |
| Interventional | IL-6 | Baseline | 17.4 pg/mL | Standard Deviation 13.6 |
| Placebo | IL-6 | Day 28 | 9.7 pg/mL | Standard Deviation 3.7 |
| Placebo | IL-6 | Baseline | 14.6 pg/mL | Standard Deviation 10 |
| Placebo | IL-6 | Day 7 | 11.1 pg/mL | Standard Deviation 8.4 |
| Placebo | IL-6 | Day 14 | 9.7 pg/mL | Standard Deviation 2.7 |
| Placebo | IL-6 | Day 21 | 10.2 pg/mL | Standard Deviation 2.1 |
Secondary
Mean Number of Days of Experiencing WHO 9-Point Ordinal Scale Values
Comparison of treatment group versus placebo group, respectively, in the mean number of days on which subjects experienced limitations, no limitations, and uninfected post treatment (60 Days).
Time frame: Post treatment through Day 60
Population: Mean number of days in which patients experienced limitations, no limitations and uninfected
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | Mean Number of Days of Experiencing WHO 9-Point Ordinal Scale Values | Limitations | 2.9 Days | Standard Deviation 1.8 |
| Interventional | Mean Number of Days of Experiencing WHO 9-Point Ordinal Scale Values | No limitations | 2.2 Days | Standard Deviation 1.9 |
| Interventional | Mean Number of Days of Experiencing WHO 9-Point Ordinal Scale Values | Uninfected | 3.0 Days | Standard Deviation 1.7 |
| Placebo | Mean Number of Days of Experiencing WHO 9-Point Ordinal Scale Values | Limitations | 2.8 Days | Standard Deviation 1.7 |
| Placebo | Mean Number of Days of Experiencing WHO 9-Point Ordinal Scale Values | No limitations | 1.7 Days | Standard Deviation 1.4 |
| Placebo | Mean Number of Days of Experiencing WHO 9-Point Ordinal Scale Values | Uninfected | 3.8 Days | Standard Deviation 2.1 |
Secondary
Oxygenation Levels
Average change from baseline over 60 days in percentage of blood saturation
Time frame: Over 60 days post randomization
Population: Patient reported oxygenation levels over 60 days.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Interventional | Oxygenation Levels | -0.01 percentage of blood saturation |
| Placebo | Oxygenation Levels | -0.01 percentage of blood saturation |
Secondary
Rates of Fever
Proportion of subjects in treatment group versus placebo group, respectively, who, per thermometer, experienced fever at any point between enrollment and day 2 post randomization.
Time frame: Days between enrollment and day 2 post randomization
Population: Patients who reported fever
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional | Rates of Fever | 1 Participants |
| Placebo | Rates of Fever | 0 Participants |
Secondary
Sustained Improvement of Global Impression Rates
Proportion of subjects in treatment group versus placebo group, respectively, who per symptom questionnaire have answered for two consecutive days: YES to In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)?; YES to In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)?
Time frame: Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization
Population: Patients reporting sustained improvement of global impression at Days 4, 7, 10, 14, 21, 28, 42, and 60
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional | Sustained Improvement of Global Impression Rates | Day 42 Returned to usual health | 16 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 4 Returned to usual health | 0 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 60 Returned to usual health | 16 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 7 Returned to usual activity | 9 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 21 Returned to usual health | 11 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 7 Returned to usual health | 5 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 14 Returned to usual activity | 15 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 4 Returned to usual activity | 0 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 21 Returned to usual activity | 15 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 14 Returned to usual health | 11 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 28 Returned to usual activity | 14 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 10 Returned to usual health | 5 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 42 Returned to usual activity | 16 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 28 Returned to usual health | 12 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 60 Returned to usual activity | 17 Participants |
| Interventional | Sustained Improvement of Global Impression Rates | Day 10 Returned to usual activity | 11 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 60 Returned to usual activity | 15 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 21 Returned to usual health | 16 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 60 Returned to usual health | 15 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 4 Returned to usual activity | 4 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 4 Returned to usual health | 0 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 10 Returned to usual health | 6 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 14 Returned to usual health | 12 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 28 Returned to usual health | 12 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 42 Returned to usual health | 16 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 7 Returned to usual activity | 9 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 10 Returned to usual activity | 15 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 14 Returned to usual activity | 17 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 21 Returned to usual activity | 17 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 28 Returned to usual activity | 13 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 42 Returned to usual activity | 17 Participants |
| Placebo | Sustained Improvement of Global Impression Rates | Day 7 Returned to usual health | 5 Participants |
Secondary
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Proportion of subjects in treatment group versus placebo group, respectively, who, per symptom questionnaire, rate stuffy or runny nose, sore throat, cough, low energy or tiredness, muscle or body ache, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, shortness of breath at rest, shortness of breath with exertion, or impairment in sense of smell or taste as mild, moderate or severe.
Time frame: Baseline and Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization
Population: Proportion of subjects in treatment group versus placebo group, respectively, who, per symptom questionnaire, rate stuffy or runny nose, sore throat, cough, low energy or tiredness, muscle or body ache, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, shortness of breath at rest, shortness of breath with exertion, or impairment in sense of smell or taste ranging from mild to moderate.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 28 | 3 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Baseline | 3 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Baseline | 13 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 21 | 4 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 42 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 4 | 4 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Baseline | 7 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 4 | 13 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 4 | 5 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 7 | 14 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 21 | 5 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 10 | 5 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Baseline | 10 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 14 | 8 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 7 | 16 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 21 | 4 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 4 | 5 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Baseline | 17 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 7 | 15 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Baseline | 4 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 4 | 4 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 4 | 4 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 10 | 4 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 7 | 5 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 4 | 10 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 10 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 14 | 5 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 14 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 10 | 6 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 21 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 21 | 3 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 28 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 7 | 18 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 42 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 28 | 5 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 7 | 14 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Baseline | 6 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 4 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 4 | 5 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 10 | 6 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 7 | 6 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 7 | 6 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 10 | 2 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 28 | 5 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 14 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 10 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 28 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 14 | 11 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 10 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 4 | 6 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 21 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 7 | 10 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 21 | 6 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 10 | 3 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 42 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 14 | 7 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 7 | 17 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 28 | 5 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 42 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 28 | 7 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 14 | 4 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Baseline | 6 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 21 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 7 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 42 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 10 | 2 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 42 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 14 | 4 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 42 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 21 | 2 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 28 | 2 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 10 | 2 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 42 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 21 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 14 | 3 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 28 | 2 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | 1Shortness of breath with exertion at Day 42 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Baseline | 13 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 21 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 21 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 14 | 12 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 42 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 28 | 2 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Baseline | 17 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 42 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 10 | 7 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 4 | 7 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 14 | 11 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 21 | 7 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 28 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 28 | 6 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 7 | 13 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 42 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Baseline | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 60 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 60 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 4 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 42 | 2 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 10 | 2 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 7 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Baseline | 7 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 28 | 2 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 42 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Baseline | 8 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 10 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 4 | 3 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 7 | 10 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 14 | 6 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 10 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 14 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 14 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 4 | 13 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 28 | 1 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 21 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 60 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 28 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Baseline | 6 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 21 | 3 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 4 | 2 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 42 | 0 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 7 | 7 Participants |
| Interventional | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Baseline | 14 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 28 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Baseline | 19 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 4 | 13 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 7 | 17 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 10 | 4 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 14 | 10 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 21 | 3 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 28 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Runny/stuffy nose at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Baseline | 14 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 4 | 3 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 7 | 9 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 10 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 14 | 2 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 21 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 28 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Baseline | 18 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 4 | 12 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Baseline | 14 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 4 | 7 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 7 | 17 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 10 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 14 | 4 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 21 | 3 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 28 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Low energy or tiredness at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Baseline | 11 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 4 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 7 | 13 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 10 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 14 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 21 | 2 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 28 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Muscle or body aches at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Baseline | 12 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 4 | 2 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 7 | 11 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 10 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 14 | 5 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 21 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Baseline | 4 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 4 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 7 | 7 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 10 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 21 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 4 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 21 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 7 | 3 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 10 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 14 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 21 | 2 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 21 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Baseline | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 4 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 7 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 10 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 14 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 28 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Vomiting at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 14 | 3 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Baseline | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Baseline | 5 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 4 | 4 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 7 | 10 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 10 | 3 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 14 | 2 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 21 | 2 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 28 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath with exertion at Day 60 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Baseline | 3 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 4 | 3 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 7 | 5 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 10 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 14 | 2 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 21 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 28 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of smell at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Baseline | 6 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 4 | 5 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 7 | 6 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 10 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 14 | 2 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Baseline | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 4 | 4 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 7 | 6 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 10 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 21 | 3 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 28 | 2 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Diarrhea at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 4 | 2 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 7 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 10 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 14 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 21 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 28 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Shortness of breath at rest at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | 1Shortness of breath with exertion at Day 42 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 21 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Impairment of sense of taste at Day 28 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Sore throat at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 7 | 18 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 10 | 9 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 14 | 15 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 21 | 6 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 28 | 3 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Cough at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 28 | 2 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 42 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Headache at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Chills or shivering at Day 28 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Baseline | 8 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 7 | 10 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 10 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 14 | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 28 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Feeling hot or feverish at Day 60 | 0 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Baseline | 1 Participants |
| Placebo | Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms | Nausea at Day 4 | 1 Participants |
Secondary
The Number of Subjects With COVID-19 Related Deterioration and Mortality Experiences
Comparison of treatment group versus placebo group, respectively, in the number of subjects who following randomization experienced hospitalization for COVID-19 related deterioration: requiring oxygen, requiring ICU admission, requiring ventilation.
Time frame: Over 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interventional | The Number of Subjects With COVID-19 Related Deterioration and Mortality Experiences | 0 participants |
| Placebo | The Number of Subjects With COVID-19 Related Deterioration and Mortality Experiences | 0 participants |
Secondary
Time in Days to Normalization of Fever and Oxygenation Levels.
Comparison in treatment group versus placebo group, respectively, of the number of days from randomization to the first day of achieving sustained (i.e., at least 2 days) resolution of fever for subjects who presented with fever at any point between enrollment and day 2 post randomization; with temperature \<38C or \>=38C experienced in total during the first 28 days post randomization; from randomization to the first day post randomization of achieving oxygenation of SpO2\>=96% in room air when resting for subjects who presented with SpO2\>93% and \<96% in room air, when resting, at enrollment; with oxygenation of SpO2\>= 96% or SpO2\>93% in room air, when resting, in total during the first 28 days post randomization.
Time frame: 28 Days
Population: NOTE: One belnacasan participant had a fever (see outcome measure 6) which resolved on Day 4 an no placebo participants had a fever above 38C.~NOTE: 2 placebo participants had oxygen saturation between 93 and 96% which increased to \>96% on Day 7 and no belnacasan participants had an oxygen saturation below 96%.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | Time in Days to Normalization of Fever and Oxygenation Levels. | Time in days to normalization of fever | 4 Days | Standard Deviation 0 |
| Placebo | Time in Days to Normalization of Fever and Oxygenation Levels. | Time in days to normalization of oxygenation level | 7 Days | Standard Deviation 0 |
Secondary
Time to Improvement on the WHO 9-Point Ordinal Scale
Comparison of treatment group versus placebo group, respectively, in the mean number of days from enrollment to reporting no limitations or uninfected. The discrepancy in patient numbers (enrolled versus analyzed) is due to patients who either dropped out or have missing data.
Time frame: Post treatment to Day 60
Population: Patients for whom there are data for reporting no limitations or uninfected
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | Time to Improvement on the WHO 9-Point Ordinal Scale | Days to no limitations | 9.3 Days | Standard Deviation 6.1 |
| Interventional | Time to Improvement on the WHO 9-Point Ordinal Scale | Days to uninfected | 27.2 Days | Standard Deviation 14.3 |
| Placebo | Time to Improvement on the WHO 9-Point Ordinal Scale | Days to no limitations | 7.1 Days | Standard Deviation 5 |
| Placebo | Time to Improvement on the WHO 9-Point Ordinal Scale | Days to uninfected | 19.0 Days | Standard Deviation 8.9 |
Secondary
Time to Sustained Improvement of Global Impression
Comparison in treatment group versus placebo group, respectively, of the mean number of days from randomization to the first day of achieving sustained improvement of global impression rates.
Time frame: Over 60 days post randomization
Population: The discrepancy in patient numbers (enrolled versus analyzed) is due to patients who either dropped out or have missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional | Time to Sustained Improvement of Global Impression | 10.5 Days | Standard Deviation 1.5 |
| Placebo | Time to Sustained Improvement of Global Impression | 13.5 Days | Standard Deviation 2.9 |
Secondary
Time to Sustained Recovery or Resolution of Common COVID-19 Symptoms
Comparison in treatment group versus placebo group, respectively, of the number of days from randomization to the first day of achieving sustained recovery and resolution rates of common COVID-19 symptoms.
Time frame: Over 60 days post randomization
Population: The discrepancy in patient numbers (enrolled versus analyzed) is due to patients who either dropped out or have missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional | Time to Sustained Recovery or Resolution of Common COVID-19 Symptoms | 20.6 Days | Standard Deviation 18.1 |
| Placebo | Time to Sustained Recovery or Resolution of Common COVID-19 Symptoms | 15.4 Days | Standard Deviation 7.8 |
Secondary
TNF-alpha
Plasma levels of TNF-alpha
Time frame: Baseline and Days 7, 14, 21, and 28
Population: Number of patients who had plasma TNF-alpha levels measured Baseline and Days 7, 14, 21, 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | TNF-alpha | Day 7 | 124.5 pg/mL | Standard Deviation 104.2 |
| Interventional | TNF-alpha | Day 21 | 121.4 pg/mL | Standard Deviation 112.6 |
| Interventional | TNF-alpha | Day 14 | 137.1 pg/mL | Standard Deviation 123.7 |
| Interventional | TNF-alpha | Day 28 | 128.4 pg/mL | Standard Deviation 140.8 |
| Interventional | TNF-alpha | Baseline | 131.1 pg/mL | Standard Deviation 99.9 |
| Placebo | TNF-alpha | Day 28 | 89.9 pg/mL | Standard Deviation 42.3 |
| Placebo | TNF-alpha | Baseline | 97.0 pg/mL | Standard Deviation 46.8 |
| Placebo | TNF-alpha | Day 7 | 97.8 pg/mL | Standard Deviation 38.9 |
| Placebo | TNF-alpha | Day 14 | 97.8 pg/mL | Standard Deviation 51.4 |
| Placebo | TNF-alpha | Day 21 | 84.0 pg/mL | Standard Deviation 46.5 |
Secondary
Values on the WHO 9-Point Ordinal Scale
Comparison of treatment group versus placebo group, respectively, in the average of daily scale value (0-8) on Days 14, 28, and 60 with respect to the number of subjects who reported as uninfected (scale value of 0), had no limitations (scale value of 1), or were experiencing limitations (scale value of 2). All patients had a score ranging between 0-2. A description of the WHO 9-Point Ordinal Scale follows: 0\. Uninfected or no clinical or virological evidence of infection * defined as subject answering Yes to In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? 1\. Not hospitalized, no limitations on activities * defined as subject answering Yes to In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)? 2. Not hospitalized, limitation on activities * defined as subject answering No to In the past 24 hours, have you returned to your usual act
Time frame: Days 14, 28, and 60 post randomization
Population: Subjects who reported a value from 0-2 on Days 14, 28, and 60.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | Values on the WHO 9-Point Ordinal Scale | Average WHO-9 point scale value at Day 14 | 1.00 units on a scale | Standard Deviation 0.69 |
| Interventional | Values on the WHO 9-Point Ordinal Scale | Average WHO-9 point scale value at Day 28 | 0.33 units on a scale | Standard Deviation 0.69 |
| Interventional | Values on the WHO 9-Point Ordinal Scale | Average WHO-9 point scale value at Day 60 | 0.00 units on a scale | Standard Deviation 0 |
| Placebo | Values on the WHO 9-Point Ordinal Scale | Average WHO-9 point scale value at Day 14 | 0.94 units on a scale | Standard Deviation 0.87 |
| Placebo | Values on the WHO 9-Point Ordinal Scale | Average WHO-9 point scale value at Day 28 | 0.17 units on a scale | Standard Deviation 0.51 |
| Placebo | Values on the WHO 9-Point Ordinal Scale | Average WHO-9 point scale value at Day 60 | 0.12 units on a scale | Standard Deviation 0.48 |