Oral Favipiravir Compared to Placebo in Subjects With Mild COVID-19

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04346628
• Collaborator: (none)
• Enrollment: 149
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.1
• Patients Per Site Per Month: 16.3

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the efficacy of oral favipiravir plus standard of care treatment (SOC) compared with placebo plus SOC in reducing the duration of shedding of SARS-CoV2 virus in patients with mild or asymptomatic COVID-19.

Condition or Disease	Intervention/Treatment	Phase
Sars-CoV2; COVID-19	Drug: Favipiravir; Drug: Placebo; Other: Standard of care treatment	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 149 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild or Asymptomatic COVID-19
• Actual Study Start Date: Jul 12, 2020
• Actual Primary Completion Date: Apr 16, 2021
• Actual Study Completion Date: Apr 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Favipiravir In addition to SOC, participants will receive favipiravir for 10 days, and be evaluated for health outcomes through day 28.	Drug: Favipiravir; Favipiravir administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).; Other: Standard of care treatment; Standard of care treatment for COVID-19 infection
Active Comparator: Placebo In addition to SOC, participants will receive placebo to match favipiravir for 10 days, and be evaluated for health outcomes through day 28.	Drug: Placebo; Placebo to match favipiravir administered orally through day 10.; Other: Standard of care treatment; Standard of care treatment for COVID-19 infection

Outcome Measures

Primary Outcome Measures

1. Time Until Cessation of Oral Shedding of SARS-CoV-2 Virus [Up to 28 days]

   Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.

Secondary Outcome Measures

1. Sars-CoV-2 Viral Load [Up to 28 days]

   Viral load (nucleic acid) will be assessed by RT-PCR Ct over time. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.

2. Count of Participants With Clinical Worsening of COVID-19 Disease [Up to 28 days]

   Clinical worsening is reported as the number of participants with hospitalization or emergency department (ED) visits.

3. Count of Participants With Development of SARS-CoV-2 Antibodies [Up to 28 days]

4. Time Until Cessation of Symptoms [Up to 28 days]

   Time until cessation of symptoms is reported as days until initial resolution and sustained resolution of symptoms.

5. Count of Participant With Absence of Development of Any Symptoms [Up to 28 days]

   This outcome will be assessed in patient who are asymptomatic of COVID-19 infection at the time of enrollment

6. Cmax of Favipiravir [Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)]

   Cmax is a pharmacokinetic parameter that measures the maximum concentration of drug in plasma.

7. Cmin of Favipiravir [Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)]

   Cmin is a pharmacokinetic parameter that measures the minimum concentration of drug in plasma.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of COVID-19 disease:

• If symptomatic, presence of mild to moderate symptoms without signs of respiratory distress, with positive for SARS-CoV-2 diagnostic assay within 72 hours prior to.informed consent.

• If asymptomatic, initial diagnosis obtained no more than 72 hours prior to informed consent

• Subject agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol

• Members of the same household may participate in the study as long as the inclusion and exclusion criteria are met

• Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication

• Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication

• Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy

• Females must have a negative pregnancy test at screening

• Participant agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol

Exclusion Criteria:

• Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will be randomized to the same treatment to maintain blinding).

• History of abnormal uric acid metabolism.

• History of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase.

• Abnormal laboratory test results at screening:

• Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19.

• Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).

• Previously received favipiravir within the past 30 days.

• Advanced kidney disease

• Advanced liver disease

• History of alcohol or drug abuse in the previous two years.

• Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year).

• Taken another investigational drug within the past 30 days.

• Seemed by the Investigator to be ineligible for any reason.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Yvonne (Bonnie) A Maldonado, MD, Stanford University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 18, 2021

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT04346628
• Other Study ID Numbers: 56032
• First Posted: Apr 15, 2020
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: COVID-19; Favipiravir

Study Results

Participant Flow

Pre-assignment Detail	385 participants were assessed for eligibility; 149 participants were enrolled and randomized.

Arm/Group Title	Placebo	Favipiravir
Arm/Group Description	In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.	In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
Period Title: Overall Study
STARTED	74	75
Intention-to-treat (ITT) Analysis Set	74	75
Symptomatic Modified ITT (smITT) Analysis Set	70	65
Modified ITT (mITT) Analysis	57	59
COMPLETED	68	62
NOT COMPLETED	6	13

Baseline Characteristics

Arm/Group Title	Placebo	Favipiravir	Total
Arm/Group Description	In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.	In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).	Total of all reporting groups
Overall Participants	70	65	135
Age (years) [Mean (Standard Deviation) ]
smITT analysis set	42.8 (12.6)	42.5 (12.0)	42.6 (12.3)
mITT analysis set	43.4 (12.8)	42.9 (12.3)	43.1 (12.5)
Sex: Female, Male (Count of Participants)
Female	37 52.9%	32 49.2%	69 51.1%
Male	33 47.1%	33 50.8%	66 48.9%
Female	29 41.4%	28 43.1%	57 42.2%
Male	28 40%	31 47.7%	59 43.7%
Race/Ethnicity, Customized (Count of Participants)
Latinx - smITT Analysis Set	29 41.4%	28 43.1%	57 42.2%
Latinx - mITT Analysis Set	24 34.3%	26 40%	50 37%
White - smITT Analysis Set	26 37.1%	22 33.8%	48 35.6%
White - mITT Analysis Set	21 30%	19 29.2%	40 29.6%
Asian - smITT Analysis Set	7 10%	6 9.2%	13 9.6%
Asian - mITT Analysis Set	5 7.1%	6 9.2%	11 8.1%
Native Hawaiian/ Pacific Islander - smITT Analysis Set	1 1.4%	3 4.6%	4 3%
Native Hawaiian/ Pacific Islander - mITT Analysis Set	1 1.4%	2 3.1%	3 2.2%
Other/Unknown - smITT Analysis Set	7 10%	6 9.2%	13 9.6%
Other/Unknown - mITT Analysis Set	6 8.6%	6 9.2%	12 8.9%
Region of Enrollment (Count of Participants)
United States	70 100%	65 100%	135 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
smITT Analysis Set	28.9 (5.9)	28.0 (5.8)	28.4 (5.8)
mITT Analysis Set	29.3 (6.0)	27.8 (5.7)	28.5 (5.9)
Comorbid Conditions (Count of Participants)
None - smITT Analysis Set	48 68.6%	47 72.3%	95 70.4%
None - mITT Analysis Set	39 55.7%	41 63.1%	80 59.3%
Diabetes mellitus - smITT Analysis Set	4 5.7%	8 12.3%	12 8.9%
Diabetes mellitus - mITT Analysis Set	3 4.3%	7 10.8%	10 7.4%
Hypertension - smITT Analysis Set	8 11.4%	6 9.2%	14 10.4%
Hypertension - mITT Analysis Set	5 7.1%	5 7.7%	10 7.4%
Chronic lung disease - smITT Analysis Set	3 4.3%	2 3.1%	5 3.7%
Chronic lung disease - mITT Analysis Set	3 4.3%	2 3.1%	5 3.7%
Asymptomatic (Count of Participants)
smITT Analysis Set	0 0%	0 0%	0 0%
mITT Analysis Set	1 1.4%	3 4.6%	4 3%
Days from symptom onset to randomization (days) [Median (Inter-Quartile Range) ]
smITT Analysis Set	5	5	5
mITT Analysis Set	5	5	5
Number of symptoms reported at randomization (symptoms) [Median (Inter-Quartile Range) ]
smITT Analysis Set	6	6	6
mITT Analysis Set	6	6	6
Symptoms at randomization (Count of Participants)
Fever - smITT Analysis Set	3 4.3%	1 1.5%	4 3%
Fever - mITT Analysis Set	2 2.9%	1 1.5%	3 2.2%
Cough/dyspnea - smITT Analysis Set	48 68.6%	47 72.3%	95 70.4%
Cough/dyspnea - mITT Analysis Set	44 62.9%	42 64.6%	86 63.7%
Fatigue - smITT Analysis Set	51 72.9%	47 72.3%	98 72.6%
Fatigue - mITT Analysis Set	41 58.6%	40 61.5%	81 60%
Joint pain - smITT Analysis Set	20 28.6%	22 33.8%	42 31.1%
Joint pain - mITT Analysis Set	18 25.7%	20 30.8%	38 28.1%
Myalgias - smITT Analysis Set	42 60%	38 58.5%	80 59.3%
Myalgias - mITT Analysis Set	36 51.4%	36 55.4%	72 53.3%
Headache - smITT Analysis Set	45 64.3%	43 66.2%	88 65.2%
Headache - mITT Analysis Set	37 52.9%	40 61.5%	77 57%
Received at least one dose of COVID-19 vaccine (Count of Participants)
smITT Analysis Set	2 2.9%	0 0%	2 1.5%
mITT Analysis Set	2 2.9%	0 0%	2 1.5%
Seropositive (Count of Participants)
smITT Analysis Set	11 15.7%	9 13.8%	20 14.8%
mITT Analysis Set	4 5.7%	6 9.2%	10 7.4%
Anterior nares RT-PCR Ct (cycles) [Median (Inter-Quartile Range) ]
smITT Analysis Set	28.3	24.3	26.2
mITT Analysis Set	25.1	22.2	24.0
Oropharyngeal RT-PCR positivity (Count of Participants)
smITT Analysis Set	52 74.3%	53 81.5%	105 77.8%
mITT Analysis Set	50 71.4%	54 83.1%	104 77%
Aspartate aminotransferase (AST) (units/L) [Median (Inter-Quartile Range) ]
smITT Analysis Set	29.5	29.0	29.0
mITT Analysis Set	32.0	29.0	29.0
Alanine Aminotransferase (ALT) (units/L) [Median (Inter-Quartile Range) ]
smITT Analysis Set	24.5	25.0	25.0
mITT Analysis Set	29.0	25.0	25.5
Creatinine (mg/dL) [Median (Inter-Quartile Range) ]
smITT Analysis Set	0.8	0.8	0.8
mITT Analysis Set	0.8	0.8	0.8
Uric acid (mg/dL) [Median (Inter-Quartile Range) ]
smITT Analysis Set	4.5	4.4	4.5
mITT Analysis Set	4.5	4.4	4.5

Outcome Measures

1. Primary Outcome

Title	Time Until Cessation of Oral Shedding of SARS-CoV-2 Virus
Description	Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Modified intention-to-treat (mITT) Analysis Set (participants who were symptomatic with positive RT-PCR result at baseline)

Arm/Group Title	Placebo	Favipiravir
Arm/Group Description	In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.	In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
Measure Participants	57	59
Median (95% Confidence Interval) [days]	13	14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Favipiravir
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.24
	Comments	The final test was performed at the alpha = 0.04999 level of significance, adjusted for age group and sex.
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.48 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio adjusted for age and sex

2. Secondary Outcome

Title	Sars-CoV-2 Viral Load
Description	Viral load (nucleic acid) will be assessed by RT-PCR Ct over time. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

mITT Analysis Set (participants who were symptomatic with positive RT-PCR result at baseline)

Arm/Group Title	Placebo	Favipiravir
Arm/Group Description	In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.	In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
Measure Participants	57	59
Day 1	25.1	22.2
Day 5	27.3	27.9
Day 10	37.3	40.0
Day 28	40.0	40.0

3. Secondary Outcome

Title	Count of Participants With Clinical Worsening of COVID-19 Disease
Description	Clinical worsening is reported as the number of participants with hospitalization or emergency department (ED) visits.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) analysis set

Arm/Group Title	Placebo	Favipiravir
Arm/Group Description	In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.	In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
Measure Participants	74	75
Hospitalization	4 5.7%	0 0%
ED visit	7 10%	5 7.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Favipiravir
	Comments	Difference in hospitalizations
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments	A p-value of 0.05 would have been considered statistically significant.
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Favipiravir
	Comments	Difference in ED visits
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.56
	Comments	A p-value of 0.05 would have been considered statistically significant.
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	Count of Participants With Development of SARS-CoV-2 Antibodies
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

ITT analysis set; participants with available data at each time point are included in the analysis

Arm/Group Title	Placebo	Favipiravir
Arm/Group Description	In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.	In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
Measure Participants	74	75
Baseline	12 17.1%	9 13.8%
Day 28	47 67.1%	40 61.5%

5. Secondary Outcome

Title	Time Until Cessation of Symptoms
Description	Time until cessation of symptoms is reported as days until initial resolution and sustained resolution of symptoms.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Symptomatic Modified Intention-to-treat (smITT) Analysis Set (participants reported at least one symptom other than mild cough, mild fatigue, or decreased taste/smell at baseline)

Arm/Group Title	Placebo	Favipiravir
Arm/Group Description	In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.	In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
Measure Participants	70	65
Initial resolution of symptoms	14	15
Sustained resolution of symptoms	24	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Favipiravir
	Comments	Difference in days until initial resolution of symptoms
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.43
	Comments	A p-value of 0.05 would have been considered statistically significant.
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.54 to 1.29
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio adjusted for age and sex

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Favipiravir
	Comments	Difference in days until sustained resolution of symptoms
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.59
	Comments	A p-value of 0.05 would have been considered statistically significant.
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.52 to 1.45
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio adjusted for age and sex

6. Secondary Outcome

Title	Count of Participant With Absence of Development of Any Symptoms
Description	This outcome will be assessed in patient who are asymptomatic of COVID-19 infection at the time of enrollment
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

smITT Analysis Set (participants reported at least one symptom other than mild cough, mild fatigue, or decreased taste/smell at baseline)

Arm/Group Title	Placebo	Favipiravir
Arm/Group Description	In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.	In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
Measure Participants	70	65
Count of Participants [Participants]	2 2.9%	5 7.7%

7. Secondary Outcome

Title	Cmax of Favipiravir
Description	Cmax is a pharmacokinetic parameter that measures the maximum concentration of drug in plasma.
Time Frame	Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)

Outcome Measure Data

Analysis Population Description

Data were not collected for this outcome measure.

Arm/Group Title	Placebo	Favipiravir
Arm/Group Description	In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.	In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
Measure Participants	0	0

8. Secondary Outcome

Title	Cmin of Favipiravir
Description	Cmin is a pharmacokinetic parameter that measures the minimum concentration of drug in plasma.
Time Frame	Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)

Outcome Measure Data

Analysis Population Description

Data were not collected for this outcome measure.

Arm/Group Title	Placebo	Favipiravir
Arm/Group Description	In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.	In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
Measure Participants	0	0

Adverse Events

Time Frame	28 days
Arm/Group Title	Placebo		Favipiravir
Arm/Group Description	In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.		In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
All Cause Mortality
	Placebo		Favipiravir
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/74 (0%)		0/75 (0%)
Serious Adverse Events
	Placebo		Favipiravir
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/74 (1.4%)		0/75 (0%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome (ARDS)	1/74 (1.4%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Favipiravir
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/74 (0%)		0/75 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.