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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | 900mg dose TID Administration Total: 2700mg |
|
| Placebo | Placebo Comparator | 0 mg dose TID Administration Total: 0 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belnacasan | Drug | Oral administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Belnacasan | Number of adverse events and serious adverse events | Through 60 days post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Subject (or legally authorized representative) provides written informed consent prior to the initiation of any study procedures
Subject understands and agrees to comply with planned study procedures, including using the diary
Subject agrees to the collection of nasopharyngeal swabs and venous blood per protocol
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
Subject has a laboratory confirmed SARS-CoV-2 infection as determined by RT-PCR assay prior to enrollment
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:
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
Subject's overall health condition is deemed as suitable to fully and safely participate in this trial as determined by the investigator
Exclusion Criteria:
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
Hospitalization for COVID-19, or consideration thereof
ICU level of care and/or non-mechanical/mechanical ventilation and/or oxygen supplementation at time of enrollment
Pregnant or breast-feeding subjects
Subjects who cannot swallow tablets
History of any pre-existing organ impairment, such as:
Elevated liver function test (determined by ALT, AST, GGT, or ALP >2x upper limit of normal, and/or total Bilirubin > upper limit of normal)
History of malignancy or immunodeficiency within the prior 5 years
Acute respiratory illness other than COVID-19
Acute bacterial, viral or fungal infection (including HIV, hepatitis B, hepatitis C)
While dosed with IP, the taking of prohibited concomitant medication or the ingestion of food that interferes with the IP, including:
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
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Wortmann, MD | MedStar Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| MedStar Franklin Square |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interventional | 900mg dose TID Administration Total: 2700mg Belnacasan: Oral administration |
| FG001 | Placebo | 0 mg dose TID Administration Total: 0mg Placebo: Tablet containing 0mg of API |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interventional | 900mg dose TID Administration Total: 2700mg Belnacasan: Oral administration |
| BG001 | Placebo | 0 mg dose TID Administration Total: 0 mg Placebo: Tablet containing 0mg of API |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability of Belnacasan | Number of adverse events and serious adverse events | Patients reporting AEs and SAEs from the time of enrollment through Day 60 | Posted | Number | Number of AEs and SAEs | Through 60 days post enrollment |
|
From the time of enrollment through Day 60
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interventional | 900mg dose TID Administration Total: 2700mg Belnacasan: Oral administration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Kroemer, MD; Khalid Kahn, MD | MedStar Health Georgetown Transplant Institute | 202-444-3700 | Alexander.Kroemer@gunet.georgetown.edu; Khalid.M.Khan@gunet.georgetown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 23, 2021 | Feb 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C520022 | belnacasan |
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Randomizations, assigned 1:1
| Drug |
Tablet containing 0mg of API |
|
| Baseline and Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization |
| 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)?" | Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization |
| 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. | Over 60 days post randomization |
| 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. | Over 60 days post randomization |
| 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. | Days between enrollment and day 2 post randomization |
| Oxygenation Levels | Average change from baseline over 60 days in percentage of blood saturation | Over 60 days post randomization |
| 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. | 28 Days |
| 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. | Days 14, 28 and 60 post randomization |
| 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. | Over 28 days |
| 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. | Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization |
| 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"
| Days 14, 28, and 60 post randomization |
| 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. | Post treatment to Day 60 |
| 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). | Post treatment through Day 60 |
| IL-6 | Plasma levels of IL-6 | Baseline and Days 7, 14, 21, 28 |
| IL-1ra | Measurement of plasma IL-1ra levels | Baseline and Days 7, 14, 21, 28 |
| IL-18 | Measurement of plasma levels of IL-18 | Baseline and Days 7, 14, 21, and 28 |
| TNF-alpha | Plasma levels of TNF-alpha | Baseline and Days 7, 14, 21, and 28 |
| Caspase-1 | Plasma levels of caspase-1 | Baseline and Days 7, 14, 21, and 28 |
| Gasdermin D | Plasma levels of gasdermin D | Baseline and Days 7, 14, 21, and 28 |
| G-CSF | Plasma levels of G-CSF | Baseline and Days 7, 14, 21, and 28 |
| Baltimore |
| Maryland |
| 21237 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization |
|
|
|
| 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)?" | Patients reporting sustained improvement of global impression at Days 4, 7, 10, 14, 21, 28, 42, and 60 | Posted | Count of Participants | Participants | Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization |
|
|
|
| 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. | The discrepancy in patient numbers (enrolled versus analyzed) is due to patients who either dropped out or have missing data. | Posted | Mean | Standard Deviation | Days | Over 60 days post randomization |
|
|
|
| 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. | The discrepancy in patient numbers (enrolled versus analyzed) is due to patients who either dropped out or have missing data. | Posted | Mean | Standard Deviation | Days | Over 60 days post randomization |
|
|
|
| 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. | Patients who reported fever | Posted | Count of Participants | Participants | Days between enrollment and day 2 post randomization |
|
|
|
| Secondary | Oxygenation Levels | Average change from baseline over 60 days in percentage of blood saturation | Patient reported oxygenation levels over 60 days. | Posted | Mean | 95% Confidence Interval | percentage of blood saturation | Over 60 days post randomization |
|
|
|
| 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. | 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%. | Posted | Mean | Standard Deviation | Days | 28 Days |
|
|
|
| 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. | 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. | Posted | Number | Number of subjects | Days 14, 28 and 60 post randomization |
|
|
|
| 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. | Posted | Number | participants | Over 28 days |
|
|
|
| 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. | 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 | Posted | Count of Participants | Participants | Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization |
|
|
|
| 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"
| Subjects who reported a value from 0-2 on Days 14, 28, and 60. | Posted | Mean | Standard Deviation | units on a scale | Days 14, 28, and 60 post randomization |
|
|
|
| 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. | Patients for whom there are data for reporting "no limitations" or "uninfected" | Posted | Mean | Standard Deviation | Days | Post treatment to Day 60 |
|
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| 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). | Mean number of days in which patients experienced "limitations", "no limitations" and "uninfected" | Posted | Mean | Standard Deviation | Days | Post treatment through Day 60 |
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| Secondary | IL-6 | Plasma levels of IL-6 | Number of patients who had plasma IL-6 levels measured Baseline and Days 7, 14, 21, 28. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Days 7, 14, 21, 28 |
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| Secondary | IL-1ra | Measurement of plasma IL-1ra levels | Number of patients who had plasma IL-1ra levels measured Baseline and Days 7, 14, 21, 28. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Days 7, 14, 21, 28 |
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| Secondary | IL-18 | Measurement of plasma levels of IL-18 | Number of patients who had plasma IL-18 levels measured Baseline and Days 7, 14, 21, 28. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Days 7, 14, 21, and 28 |
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| Secondary | TNF-alpha | Plasma levels of TNF-alpha | Number of patients who had plasma TNF-alpha levels measured Baseline and Days 7, 14, 21, 28. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Days 7, 14, 21, and 28 |
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| Secondary | Caspase-1 | Plasma levels of caspase-1 | Number of patients who had plasma caspase-1 levels measured Baseline and Days 7, 14, 21, 28. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Days 7, 14, 21, and 28 |
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| Secondary | Gasdermin D | Plasma levels of gasdermin D | Number of patients who had plasma gasdermin D levels measured Baseline and Days 7, 14, 21, 28. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Days 7, 14, 21, and 28 |
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| Secondary | G-CSF | Plasma levels of G-CSF | Number of patients who had plasma G-CSF levels measured Baseline and Days 7, 14, 21, 28. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Days 7, 14, 21, and 28 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | Placebo | 0 mg dose TID Administration Total: 0mg Placebo: Tablet containing 0mg of API | 0 | 20 | 0 | 20 | 0 | 20 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Runny/stuffy nose at Day 4 |
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| Runny/stuffy nose at Day 7 |
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| Runny/stuffy nose at Day 10 |
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| Runny/stuffy nose at Day 14 |
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| Runny/stuffy nose at Day 21 |
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| Runny/stuffy nose at Day 28 |
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| Runny/stuffy nose at Day 42 |
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| Runny/stuffy nose at Day 60 |
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| Sore throat at Baseline |
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| Sore throat at Day 4 |
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| Sore throat at Day 7 |
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| Sore throat at Day 10 |
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| Sore throat at Day 14 |
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| Sore throat at Day 21 |
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| Sore throat at Day 28 |
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| Sore throat at Day 42 |
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| Sore throat at Day 60 |
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| Cough at Baseline |
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| Cough at Day 4 |
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| Cough at Day 7 |
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| Cough at Day 10 |
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| Cough at Day 14 |
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| Cough at Day 21 |
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| Cough at Day 28 |
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| Cough at Day 42 |
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| Cough at Day 60 |
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| Low energy or tiredness at Baseline |
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| Low energy or tiredness at Day 4 |
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| Low energy or tiredness at Day 7 |
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| Low energy or tiredness at Day 10 |
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| Low energy or tiredness at Day 14 |
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| Low energy or tiredness at Day 21 |
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| Low energy or tiredness at Day 28 |
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| Low energy or tiredness at Day 42 |
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| Low energy or tiredness at Day 60 |
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| Muscle or body aches at Baseline |
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| Muscle or body aches at Day 4 |
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| Muscle or body aches at Day 7 |
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| Muscle or body aches at Day 10 |
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| Muscle or body aches at Day 14 |
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| Muscle or body aches at Day 21 |
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| Muscle or body aches at Day 28 |
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| Muscle or body aches at Day 42 |
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| Muscle or body aches at Day 60 |
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| Headache at Baseline |
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| Headache at Day 4 |
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| Headache at Day 7 |
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| Headache at Day 10 |
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| Headache at Day 14 |
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| Headache at Day 21 |
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| Headache at Day 28 |
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| Headache at Day 42 |
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| Headache at Day 60 |
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| Chills or shivering at Baseline |
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| Chills or shivering at Day 4 |
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| Chills or shivering at Day 7 |
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| Chills or shivering at Day 10 |
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| Chills or shivering at Day |
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| Chills or shivering at Day 21 |
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| Chills or shivering at Day 28 |
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| Chills or shivering at Day 42 |
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| Chills or shivering at Day 60 |
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| Feeling hot or feverish at Baseline |
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| Feeling hot or feverish at Day 4 |
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| Feeling hot or feverish at Day 7 |
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| Feeling hot or feverish at Day 10 |
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| Feeling hot or feverish at Day 14 |
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| Feeling hot or feverish at Day 21 |
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| Feeling hot or feverish at Day 28 |
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| Feeling hot or feverish at Day 42 |
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| Feeling hot or feverish at Day 60 |
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| Nausea at Baseline |
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| Nausea at Day 4 |
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| Nausea at Day 7 |
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| Nausea at Day 10 |
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| Nausea at Day 14 |
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| Nausea at Day 21 |
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| Nausea at Day 28 |
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| Nausea at Day 42 |
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| Nausea at Day 60 |
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| Vomiting at Baseline |
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| Vomiting at Day 4 |
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| Vomiting at Day 7 |
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| Vomiting at Day 10 |
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| Vomiting at Day 14 |
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| Vomiting at Day 21 |
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| Vomiting at Day 28 |
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| Vomiting at Day 42 |
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| Vomiting at Day 60 |
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| Diarrhea at Baseline |
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| Diarrhea at Day 4 |
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| Diarrhea at Day 7 |
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| Diarrhea at Day 10 |
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| Diarrhea at Day 14 |
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| Diarrhea at Day 21 |
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| Diarrhea at Day 28 |
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| Diarrhea at Day 42 |
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| Diarrhea at Day 60 |
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| Shortness of breath at rest at Baseline |
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| Shortness of breath at rest at Day 4 |
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| Shortness of breath at rest at Day 7 |
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| Shortness of breath at rest at Day 10 |
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| Shortness of breath at rest at Day 14 |
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| Shortness of breath at rest at Day 21 |
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| Shortness of breath at rest at Day 28 |
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| Shortness of breath at rest at Day 42 |
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| Shortness of breath at rest at Day 60 |
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| Shortness of breath with exertion at Baseline |
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| Shortness of breath with exertion at Day 4 |
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| Shortness of breath with exertion at Day 7 |
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| Shortness of breath with exertion at Day 10 |
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| Shortness of breath with exertion at Day 14 |
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| Shortness of breath with exertion at Day 21 |
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| Shortness of breath with exertion at Day 28 |
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| 1Shortness of breath with exertion at Day 42 |
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| Shortness of breath with exertion at Day 60 |
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| Impairment of sense of smell at Baseline |
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| Impairment of sense of smell at Day 4 |
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| Impairment of sense of smell at Day 7 |
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| Impairment of sense of smell at Day 10 |
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| Impairment of sense of smell at Day 14 |
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| Impairment of sense of smell at Day 21 |
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| Impairment of sense of smell at Day 28 |
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| Impairment of sense of smell at Day 42 |
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| Impairment of sense of smell at Day 60 |
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| Impairment of sense of taste at Baseline |
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| Impairment of sense of taste at Day 4 |
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| Impairment of sense of taste at Day 7 |
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| Impairment of sense of taste at Day 10 |
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| Impairment of sense of taste at Day 14 |
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| Impairment of sense of taste at Day 21 |
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| Impairment of sense of taste at Day 28 |
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| Impairment of sense of taste at Day 42 |
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| Impairment of sense of taste at Day 60 |
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|
| Day 7 "Returned to usual health" |
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| Day 10 "Returned to usual health" |
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| Day 14 "Returned to usual health" |
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| Day 21 "Returned to usual health" |
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| Day 28 "Returned to usual health" |
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| Day 42 "Returned to usual health" |
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| Day 60 "Returned to usual health" |
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| Day 4 "Returned to usual activity" |
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| Day 7 "Returned to usual activity" |
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| Day 10 "Returned to usual activity" |
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| Day 14 "Returned to usual activity" |
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| Day 21 "Returned to usual activity" |
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| Day 28 "Returned to usual activity" |
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| Day 42 "Returned to usual activity" |
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| Day 60 "Returned to usual activity" |
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| Time in days to normalization of oxygenation level |
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| Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 28 |
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| Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 60 |
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| Subjects who required oxygen or ventilation by Day 14 |
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| Subjects who required oxygen or ventilation by Day 28 |
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| Subjects who required oxygen or ventilation by Day 60 |
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| Day 7 |
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| Day 10 |
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| Day 14 |
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| Day 21 |
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| Day 28 |
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| Day 42 |
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| Day 60 |
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| Average WHO-9 point scale value at Day 28 |
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| Average WHO-9 point scale value at Day 60 |
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| Days to "uninfected" |
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| Uninfected |
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| Day 7 |
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| Day 14 |
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| Day 21 |
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| Day 28 |
|
|
| Day 7 |
|
|
| Day 14 |
|
|
| Day 21 |
|
|
| Day 28 |
|
|
| Day 7 |
|
|
| Day 14 |
|
|
| Day 21 |
|
|
| Day 28 |
|
|
| Day 7 |
|
|
| Day 14 |
|
|
| Day 21 |
|
|
| Day 28 |
|
|
| Day 7 |
|
|
| Day 14 |
|
|
| Day 21 |
|
|
| Day 28 |
|
|
| Day 7 |
|
|
| Day 14 |
|
|
| Day 21 |
|
|
| Day 28 |
|
|
| Day 7 |
|
|
| Day 14 |
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| Day 21 |
|
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| Day 28 |
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|