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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
149
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).
Placebo to match favipiravir administered orally through day 10.
Standard of care treatment for COVID-19 infection
Stanford University
Stanford, California, United States
Time Until Cessation of Oral Shedding of SARS-CoV-2 Virus
Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.
Time frame: Up to 28 days
Sars-CoV-2 Viral Load
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
Count of Participants With Clinical Worsening of COVID-19 Disease
Clinical worsening is reported as the number of participants with hospitalization or emergency department (ED) visits.
Time frame: Up to 28 days
Count of Participants With Development of SARS-CoV-2 Antibodies
Time frame: Up to 28 days
Time Until Cessation of Symptoms
Time until cessation of symptoms is reported as days until initial resolution and sustained resolution of symptoms.
Time frame: Up to 28 days
Count of Participant With Absence of Development of Any Symptoms
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
Cmax of Favipiravir
Cmax is a pharmacokinetic parameter that measures the maximum concentration of drug in plasma.
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Time frame: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)
Cmin of Favipiravir
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)