COVID-19
Conditions
Keywords
COVID-19, Pyramax, Pyronaridine, Artesunate, Chloroquine, Zinc, Amodiaquine, Favipiravir, Nitazoxanide, Sofosbuvir, Daclatasvir
Brief summary
This exploratory study is a randomized, single center, open label study of four different experimental treatment arms versus standard of care for the treatment of SARS-CoV-2 infection in symptomatic outpatients with mild disease at the time of enrollment.
Detailed description
This phase 2, exploratory study will be an adaptive, randomized, open label, trial for treatment of individuals in an outpatient settings with mild SARS-CoV-2 infection. The primary outcome is focused on the evaluation of efficacy of the proposed experimental drugs in reducing upper respiratory viral shedding, defined as viral clearance (i.e., negative swab) on Day 7. Key secondary outcomes focus on other measures of viral shedding, safety evaluation, progression to LRTI (defined by resting blood oxygen saturation level \[SpO2\] \<93% sustained for two readings two hours apart and presence of subjective dyspnoea or cough), disease severity, clinical resolution rate, and cumulative incidence of hospitalization or mortality at Day 28.
Interventions
DRUGParacetamol
SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed
SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days
SOC plus pyronaridine-artesunate (PA) Weight 45 to \<65 kg: 3 tablets (540/180 mg pyronaridine/artesunate) daily for 3 days Weight ≥65 kg: 4 tablets (720/240 mg pyronaridine/artesunate) daily for 3 days
DRUGFavipiravir plus Nitazoxanide
SOC plus favipiravir plus nitazoxanide (FPV-NTZ) Favipiravir: 1600 mg 12-hourly for 1 day then 600 mg 12-hourly for 6 days Nitazoxanide: 2 tablets (1000 mg) 12-hourly for 7 days
SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Sponsors
Medicines for Malaria Venture
Shin Poong Pharmaceutical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age from 18 to 65 years of age, inclusive, at the time of signing the informed consent. 2. Willing and able to provide informed consent. 3. Women of reproductive potential must be using a highly effective method of contraception for at least 28 days prior to enrolment and must be able and willing to continue its use throughout the duration of the study. 4. Men must agree to use condoms when engaging in heterosexual sex during the study and for the period up to 91 days after the last dose of study medication. Men who are not randomized to a treatment arm including favipiravir (or another arm identified as having teratogenic potential through semen) will no longer need to adhere to this after randomization. 5. Laboratory confirmed SARS-CoV-2 infection, and any of the following self-reported symptoms within 72 hours prior to randomization: fever or chills, cough, myalgia, sore throat, shortness of breath, or new onset of anosmia or ageusia. 6. Body weight ≥45 kg. 7. Access to reliable video conference, telephone, direct/text messaging, or other device permitting real-time, reliable information transfer.
Exclusion criteria
1. Pregnant or lactating women. 2. Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms, or similar compounds. 3. Signs of respiratory distress prior to randomization, including: * respiratory rate \>24 breaths/min * SpO2 \<95% in room air. 4. Resting pulse rate ≥120 beats/min. 5. High likelihood of hospitalization in the opinion of the attending clinician. 6. QTcF \>470 msec for females, or \>450 msec for males, at screening. 7. Serum potassium \<3.5 mmol/L at screening. 8. History of clinically significant cardiovascular disease (including arrhythmias, QT-interval prolongation, torsades de pointes (TdP), history of coronary artery disease with graft or stent procedures/surgery, cardiac failure \[class 2 or higher using the New York Heart Association functional classification\]). 9. Known chronic kidney disease (Stage IV or receiving dialysis). 10. Known cirrhosis (Child-Pugh Class B or greater). 11. Known macular degeneration, or other known retinal diseases, or 4-aminoquinolone-induced visual impairment. 12. Currently receiving, or recently received (within 60 days prior to randomization) treatment with any of the drugs in the treatment arms. 13. Currently receiving, or recently received (within 30 days prior to randomization) treatment with any antimalarial drugs. 14. Currently on treatment with drugs with known arrhythmogenic potential, or those known to induce significant QT-interval prolongation or TdP, as detailed in Appendix 6. 15. Currently on treatment for tuberculosis (or on treatment with rifampicin for any other indication), or on treatment with a protease inhibitor-based antiretroviral regimen, or efavirenz, or carbamazepine. 16. Inability/unlikely to be in the study area for the duration of the 28 day follow-up period. 17. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study. The Investigator should make this determination in consideration of the volunteer's medical history. 18. Personnel (e.g. investigator, sub-investigator, research assistant, pharmacist, study coordinator or anyone mentioned in the delegation log) directly involved in the conduct of the study. 19. Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of SARS-CoV-2 Clearance | Day 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Clearance of Nasal SARS-CoV-2 | Day 0, 3, 7, 10, 14, 21, 28 | — |
| Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR | Day 14 | baseline and day14, Day 14 value minus baseline value |
| Poisson Regression for Proportion of Days With Fever After Randomization | Day 28 | — |
| Percentage of Days With Respiratory Symptoms After Randomization | from randomization to end of study (until day 28) | Percentage of total study days in which participants experienced respiratory symptoms until day 28. Percentage calculated as (No. of days with respiratory symptoms) ÷ (No. of days observation) x 100 |
| FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days | 14 days | baseline and day 14, Day 14 value minus baseline value The FLU-PRO(inFLUenza Patient-Reported Outcome) Plus questionnaire was completed daily during the first 14 days, at Day 21 and at Day 28. From these items six domain scores for the body areas Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, and Body/Systemic could be computed ranging from 0 (symptom free) to 4 (very severe symptoms). Total Score Range for FLU-PRO Plus * Score range per item: 0 (no symptoms) to 4 (very severe symptoms). A higher score indicates worse symptoms. * Total score calculation: The mean (average) of all item scores is used. (Minimum score: 0, Maximum score: 4) |
| Serious Adverse Events | Day 28 | — |
| Incidence of SARS-CoV-2 Clearance | Day 3, 10, 14, 21, 28 | — |
| Related Adverse Events | Day 28 | — |
| LRTI | Day 28 | — |
| Maximum Score on WHO Ordinal Scale for Clinical Improvement During Study Participation | Day 28 | — |
| Cumulative Incidence of Hospitalization | Day 28 | — |
| Days of Hospitalization | Day 28 | Total number of hospitalization days for hospitalized participants in each group |
| Cumulative Incidence of Mortality, Measured at Day 28 or Later if Participant is Hospitalized at the Time of Day 28 | at Day 28 or later if participant is hospitalized at the time of Day 28 for up to 2 months | — |
| Adverse Events | Day 28 | — |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paracetamol (SOC) Paracetamol (SOC)
Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed | 39 |
| ASAQ SOC plus Artesunate-Amodiaquine
Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days | 39 |
| PA(Pyronaridine-Artesunate) SOC plus Pyronaridine-Artesunate
Pyronaridine-artesunate: SOC plus pyronaridine-artesunate (PA) Weight 45 to \<65 kg: 3 tablets (540/180 mg pyronaridine/artesunate) daily for 3 days Weight ≥65 kg: 4 tablets (720/240 mg pyronaridine/artesunate) daily for 3 days | 36 |
| FPV-NTZ SOC plus Favipiravir plus Nitazoxanide
Favipiravir plus Nitazoxanide: SOC plus favipiravir plus nitazoxanide (FPV-NTZ) Favipiravir: 1600 mg 12-hourly for 1 day then 600 mg 12-hourly for 6 days Nitazoxanide: 2 tablets (1000 mg) 12-hourly for 7 days | 37 |
| SOF/DCV SOC plus Sofosbuvir/daclatasvir
Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV)
1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days | 35 |
| Total | 186 |
Baseline characteristics
| Characteristic | Paracetamol (SOC) | ASAQ | PA(Pyronaridine-Artesunate) | FPV-NTZ | SOF/DCV | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 39 Participants | 35 Participants | 37 Participants | 35 Participants | 185 Participants |
| Age, Continuous | 33.7 years STANDARD_DEVIATION 9.93 | 36 years STANDARD_DEVIATION 10.32 | 35.9 years STANDARD_DEVIATION 11.28 | 34 years STANDARD_DEVIATION 9.43 | 34.8 years STANDARD_DEVIATION 10.58 | 34.9 years STANDARD_DEVIATION 10.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 32 Participants | 34 Participants | 32 Participants | 31 Participants | 165 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 8 Participants |
| Region of Enrollment South Africa Asian or Indian | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 7 Participants |
| Region of Enrollment South Africa Black African | 36 Participants | 32 Participants | 34 Participants | 32 Participants | 31 Participants | 165 Participants |
| Region of Enrollment South Africa Coloured | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 2 Participants | 6 Participants |
| Region of Enrollment South Africa Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Africa White | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Female | 24 Participants | 25 Participants | 20 Participants | 15 Participants | 15 Participants | 99 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 16 Participants | 22 Participants | 20 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 | 0 / 38 | 0 / 36 | 0 / 36 |
| other Total, other adverse events | 14 / 39 | 18 / 39 | 21 / 38 | 31 / 36 | 16 / 36 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 | 0 / 38 | 1 / 36 | 0 / 36 |
Outcome results
Primary
Incidence of SARS-CoV-2 Clearance
Time frame: Day 7
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Incidence of SARS-CoV-2 Clearance | 34.2 percentage of paticaipants |
| Arm B | Incidence of SARS-CoV-2 Clearance | 38.5 percentage of paticaipants |
| Arm C | Incidence of SARS-CoV-2 Clearance | 30.3 percentage of paticaipants |
| Arm D | Incidence of SARS-CoV-2 Clearance | 27.0 percentage of paticaipants |
| Arm E | Incidence of SARS-CoV-2 Clearance | 23.5 percentage of paticaipants |
Secondary
Adverse Events
Time frame: Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A | Adverse Events | 0 Participants |
| Arm B | Adverse Events | 0 Participants |
| Arm C | Adverse Events | 0 Participants |
| Arm D | Adverse Events | 1 Participants |
| Arm E | Adverse Events | 1 Participants |
Secondary
Cumulative Incidence of Hospitalization
Time frame: Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A | Cumulative Incidence of Hospitalization | 0 Participants |
| Arm B | Cumulative Incidence of Hospitalization | 0 Participants |
| Arm C | Cumulative Incidence of Hospitalization | 1 Participants |
| Arm D | Cumulative Incidence of Hospitalization | 0 Participants |
| Arm E | Cumulative Incidence of Hospitalization | 1 Participants |
Secondary
Cumulative Incidence of Mortality, Measured at Day 28 or Later if Participant is Hospitalized at the Time of Day 28
Time frame: at Day 28 or later if participant is hospitalized at the time of Day 28 for up to 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A | Cumulative Incidence of Mortality, Measured at Day 28 or Later if Participant is Hospitalized at the Time of Day 28 | 0 Participants |
| Arm B | Cumulative Incidence of Mortality, Measured at Day 28 or Later if Participant is Hospitalized at the Time of Day 28 | 0 Participants |
| Arm C | Cumulative Incidence of Mortality, Measured at Day 28 or Later if Participant is Hospitalized at the Time of Day 28 | 0 Participants |
| Arm D | Cumulative Incidence of Mortality, Measured at Day 28 or Later if Participant is Hospitalized at the Time of Day 28 | 0 Participants |
| Arm E | Cumulative Incidence of Mortality, Measured at Day 28 or Later if Participant is Hospitalized at the Time of Day 28 | 0 Participants |
Secondary
Days of Hospitalization
Total number of hospitalization days for hospitalized participants in each group
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Days of Hospitalization | 0 Days | Standard Deviation 0 |
| Arm B | Days of Hospitalization | 0 Days | Standard Deviation 0 |
| Arm C | Days of Hospitalization | 6.00 Days | Standard Deviation 0 |
| Arm D | Days of Hospitalization | 0 Days | Standard Deviation 0 |
| Arm E | Days of Hospitalization | 6.00 Days | Standard Deviation 0 |
Secondary
Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR
baseline and day14, Day 14 value minus baseline value
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR | -3.81 Log₁₀ copies/mL | Standard Deviation 2.576 |
| Arm B | Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR | -3.35 Log₁₀ copies/mL | Standard Deviation 2.531 |
| Arm C | Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR | -3.30 Log₁₀ copies/mL | Standard Deviation 2.283 |
| Arm D | Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR | -3.50 Log₁₀ copies/mL | Standard Deviation 2.691 |
| Arm E | Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR | -2.98 Log₁₀ copies/mL | Standard Deviation 2.757 |
Secondary
FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days
baseline and day 14, Day 14 value minus baseline value The FLU-PRO(inFLUenza Patient-Reported Outcome) Plus questionnaire was completed daily during the first 14 days, at Day 21 and at Day 28. From these items six domain scores for the body areas Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, and Body/Systemic could be computed ranging from 0 (symptom free) to 4 (very severe symptoms). Total Score Range for FLU-PRO Plus * Score range per item: 0 (no symptoms) to 4 (very severe symptoms). A higher score indicates worse symptoms. * Total score calculation: The mean (average) of all item scores is used. (Minimum score: 0, Maximum score: 4)
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Arm A | FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days | -0.750 score | Standard Deviation 0.827 |
| Arm B | FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days | -0.750 score | Standard Deviation 1.0046 |
| Arm C | FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days | -0.750 score | Standard Deviation 0.9079 |
| Arm D | FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days | -1.250 score | Standard Deviation 0.9135 |
| Arm E | FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days | -0.750 score | Standard Deviation 0.5711 |
Secondary
Incidence of SARS-CoV-2 Clearance
Time frame: Day 3, 10, 14, 21, 28
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A | Incidence of SARS-CoV-2 Clearance | Day 21 | 66.7 percentage of paticaipants |
| Arm A | Incidence of SARS-CoV-2 Clearance | Day 3 | 28.2 percentage of paticaipants |
| Arm A | Incidence of SARS-CoV-2 Clearance | Day 28 | 71.8 percentage of paticaipants |
| Arm A | Incidence of SARS-CoV-2 Clearance | Day 10 | 33.3 percentage of paticaipants |
| Arm A | Incidence of SARS-CoV-2 Clearance | Day 14 | 56.4 percentage of paticaipants |
| Arm B | Incidence of SARS-CoV-2 Clearance | Day 21 | 53.8 percentage of paticaipants |
| Arm B | Incidence of SARS-CoV-2 Clearance | Day 14 | 51.3 percentage of paticaipants |
| Arm B | Incidence of SARS-CoV-2 Clearance | Day 10 | 33.3 percentage of paticaipants |
| Arm B | Incidence of SARS-CoV-2 Clearance | Day 28 | 66.7 percentage of paticaipants |
| Arm B | Incidence of SARS-CoV-2 Clearance | Day 3 | 17.9 percentage of paticaipants |
| Arm C | Incidence of SARS-CoV-2 Clearance | Day 14 | 45.7 percentage of paticaipants |
| Arm C | Incidence of SARS-CoV-2 Clearance | Day 3 | 17.1 percentage of paticaipants |
| Arm C | Incidence of SARS-CoV-2 Clearance | Day 10 | 40.0 percentage of paticaipants |
| Arm C | Incidence of SARS-CoV-2 Clearance | Day 21 | 68.6 percentage of paticaipants |
| Arm C | Incidence of SARS-CoV-2 Clearance | Day 28 | 68.6 percentage of paticaipants |
| Arm D | Incidence of SARS-CoV-2 Clearance | Day 28 | 73.0 percentage of paticaipants |
| Arm D | Incidence of SARS-CoV-2 Clearance | Day 3 | 24.3 percentage of paticaipants |
| Arm D | Incidence of SARS-CoV-2 Clearance | Day 21 | 64.9 percentage of paticaipants |
| Arm D | Incidence of SARS-CoV-2 Clearance | Day 14 | 51.4 percentage of paticaipants |
| Arm D | Incidence of SARS-CoV-2 Clearance | Day 10 | 29.7 percentage of paticaipants |
| Arm E | Incidence of SARS-CoV-2 Clearance | Day 14 | 51.4 percentage of paticaipants |
| Arm E | Incidence of SARS-CoV-2 Clearance | Day 21 | 68.6 percentage of paticaipants |
| Arm E | Incidence of SARS-CoV-2 Clearance | Day 3 | 14.3 percentage of paticaipants |
| Arm E | Incidence of SARS-CoV-2 Clearance | Day 28 | 68.6 percentage of paticaipants |
| Arm E | Incidence of SARS-CoV-2 Clearance | Day 10 | 34.3 percentage of paticaipants |
Secondary
LRTI
Time frame: Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A | LRTI | 0 Participants |
| Arm B | LRTI | 0 Participants |
| Arm C | LRTI | 2 Participants |
| Arm D | LRTI | 0 Participants |
| Arm E | LRTI | 1 Participants |
Secondary
Maximum Score on WHO Ordinal Scale for Clinical Improvement During Study Participation
Time frame: Day 28
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Arm A | Maximum Score on WHO Ordinal Scale for Clinical Improvement During Study Participation | 1 score | Standard Deviation 0.5 |
| Arm B | Maximum Score on WHO Ordinal Scale for Clinical Improvement During Study Participation | 0 score | Standard Deviation 0.6 |
| Arm C | Maximum Score on WHO Ordinal Scale for Clinical Improvement During Study Participation | 1 score | Standard Deviation 0.76 |
| Arm D | Maximum Score on WHO Ordinal Scale for Clinical Improvement During Study Participation | 1 score | Standard Deviation 0.43 |
| Arm E | Maximum Score on WHO Ordinal Scale for Clinical Improvement During Study Participation | 1 score | Standard Deviation 0.81 |
Secondary
Percentage of Days With Respiratory Symptoms After Randomization
Percentage of total study days in which participants experienced respiratory symptoms until day 28. Percentage calculated as (No. of days with respiratory symptoms) ÷ (No. of days observation) x 100
Time frame: from randomization to end of study (until day 28)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A | Percentage of Days With Respiratory Symptoms After Randomization | 35.66 Percentage (%) |
| Arm B | Percentage of Days With Respiratory Symptoms After Randomization | 28.034 Percentage (%) |
| Arm C | Percentage of Days With Respiratory Symptoms After Randomization | 33.469 Percentage (%) |
| Arm D | Percentage of Days With Respiratory Symptoms After Randomization | 29.602 Percentage (%) |
| Arm E | Percentage of Days With Respiratory Symptoms After Randomization | 35.306 Percentage (%) |
Secondary
Poisson Regression for Proportion of Days With Fever After Randomization
Time frame: Day 28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Poisson Regression for Proportion of Days With Fever After Randomization | 0.596 proportion |
| Arm B | Poisson Regression for Proportion of Days With Fever After Randomization | 0.000 proportion |
| Arm C | Poisson Regression for Proportion of Days With Fever After Randomization | 1.732 proportion |
| Arm D | Poisson Regression for Proportion of Days With Fever After Randomization | 0.599 proportion |
| Arm E | Poisson Regression for Proportion of Days With Fever After Randomization | 0.835 proportion |
Secondary
Related Adverse Events
Time frame: Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A | Related Adverse Events | 0 Participants |
| Arm B | Related Adverse Events | 11 Participants |
| Arm C | Related Adverse Events | 12 Participants |
| Arm D | Related Adverse Events | 21 Participants |
| Arm E | Related Adverse Events | 10 Participants |
Secondary
Serious Adverse Events
Time frame: Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A | Serious Adverse Events | 0 Participants |
| Arm B | Serious Adverse Events | 0 Participants |
| Arm C | Serious Adverse Events | 0 Participants |
| Arm D | Serious Adverse Events | 1 Participants |
| Arm E | Serious Adverse Events | 0 Participants |
Secondary
Time to Clearance of Nasal SARS-CoV-2
Time frame: Day 0, 3, 7, 10, 14, 21, 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A | Time to Clearance of Nasal SARS-CoV-2 | 10 Time(day) |
| Arm B | Time to Clearance of Nasal SARS-CoV-2 | 7 Time(day) |
| Arm C | Time to Clearance of Nasal SARS-CoV-2 | 8.5 Time(day) |
| Arm D | Time to Clearance of Nasal SARS-CoV-2 | 14 Time(day) |
| Arm E | Time to Clearance of Nasal SARS-CoV-2 | 8.5 Time(day) |