Double-blinded, placebo control, randomized, phase-3 clinical trial to evaluate clinical efficacy of Favipiravir in patients with mild to moderate symptoms related to COVID-19 infection
COVID-19 starts as a pure viral infection and evolves into a multifactorial disease with components of hyper immune activation, end organ damage, and fibrosis. Suppression of viral replication is expected to be impactful early in the course of disease. The ability to mitigate the symptoms at an early stage will prevent progression to severe COVID-19 and can save many lives. Early treatment could also reduce viral shedding, diminishing the period of infectivity and decreasing the number of secondary cases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,187
Favipiravir
Placebo
Number of Participants With Sustained Clinical Recovery
The endpoint will be considered to have been met at the earliest time point at which the subject has reached Sustained Alleviation of Symptoms (Symptoms related to smell or taste are not included in the primary endpoint) reported by the patient have reached a severity of "0 - none" or "1 - mild" in assessments for 4-point scale assessments and not known to have redeveloped any COVID-19 associated signs and symptoms (not including reduced sense of taste or smell) in a severity beyond mild for 4 consecutive days when assessed from the start of study treatment to day 28. To meet the primary endpoint, subjects must survive with no hospitalization to day 28.
Time frame: From Day 0 to Day 28
Proportion of Subjects With COVID-19 Progression (Narrow Progression)
Proportion of subjects with COVID-19 progression, where progression is defined as the occurrence from study day 3 onward of any emergency department (ED) visit for COVID-19 worsening or shortness of breath OR hospitalization for COVID-19 worsening or shortness of breath OR death (narrow progression)
Time frame: From study day 3 to day 28
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Cahaba Research, Inc.
Pelham, Alabama, United States
Absolute Clinical Research
Phoenix, Arizona, United States
B.G Clinical Research Center, LLC
Little Rock, Arkansas, United States
Xera Med Research
Boca Raton, Florida, United States
Synergy Healthcare
Bradenton, Florida, United States
Best Quality Research,Inc.
Hialeah, Florida, United States
Elixia Clinical Research Collaborative
Hollywood, Florida, United States
Homestead Associates In Research
Miami, Florida, United States
Verus Clinical Research Corporation
Miami, Florida, United States
Quality Professional HealthCare
Miami, Florida, United States
...and 28 more locations