Study to Assess the Efficacy and Safety of Favipiravir-HU

Study Overview
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Brief Summary
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The aim of the study is to assess the safety and efficacy of Favipiravir HU when administered to SARS-Cov- 2 patients in order to offer a safe and effective treatment to SARS-Cov-2 infection during the pandemic. The study is not for registration purposes and is not part of a series of studies for registration of Favipiravir HU.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Favipiravir-HU Compared to Placebo as add-on Therapy to Standard of Care in Asymptomatic to Mild Severity COVID-19 Patients

Conditions
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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Intervention / Treatment
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* Drug: Favipiravir HU 200 mg hard capsules
* Drug: Placebo HU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients between the ages of 18 and 65 years. Patients with PCR confirmed SARS-CoV-2 infection Asymptomatic or have mild only symptoms and symptoms are onset less than 5 days Signed Informed Consent Form and Patient Information Leaflet Exclusion Criteria: Pregnant or possibly pregnant patients or lactating females Patients have moderate to severe or immediately life-threatening COVID-19 Major risk factor onset (Obesity, Diabetes, COPD, Hypertension) Patients with SpO2 less than 95% without oxygen therapy Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification Patients with renal impairment requiring dialysis Patients with disturbed consciousness such as disturbed orientation Female patients who are woman of childbearing potential and unable to consent to use of dual contraception from the start of favipiravir administration to 30 days after the end of favipiravir administration. Dual contraception is a combination of two of the following: Barrier method of contraception: condoms (male or female) with orwithout a spermicidal agent, diaphragm or cervical cap with spermicide; IUD; Hormone-based contraceptive; Tubal ligation Male patients whose are unable to consent to use of barrier method of contraception (condom) the start of favipiravir administration to 90 days after the end of favipiravir administration. Male patients who are planning to donate sperm in 90 days after the start of favipiravir administration. Patients with hereditary xanthinuria Patient with severe uncontrolled hyperuricaemia Patients receiving immunosuppressants Patients who received interferon-alpha or drugs with reported antiviral activity against SARS-CoV- 2 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, remdesivir, etc.) within 72 hours or Patients who receive forbidden concomitant medication Any medical condition that the examining physician deems unsuitable for the patient to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Favipiravir HU + SOC<br>Favipiravir HU + SOC | Drug: Favipiravir HU 200 mg hard capsules<br>* Drug substance: Favipiravir Dose: 200 mg Administration: oral Formulation: capsules<br>|
| Placebo Comparator: Placebo HU + SOC<br>Placebo HU + SOC | Drug: Placebo HU<br>* Name: Placebo clinical sample Drug substance: placebo Dose: - Administration: oral Formulation: capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRIM1_ the percentage of virus copy number | The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SEC1_mortality rate | Overall mortality rate | 6 months | 
| SEC2_respiratory failure | Proportion of patients with respiratory failure | 6 months | 
| SEC3_ intensive care | Proportion of patients with need for intensive care | 6 months | 
| SEC4_non-invasive respiratory support | Proportion of patients with need for non-invasive respiratory support | 6 months | 
| SEC5_ invasive respiratory support | Proportion of patients with need for invasive respiratory support | 6 months | 
| SEC6_ Acute Respiratory Distress Syndrome | Proportion of patients with Acute Respiratory Distress Syndrome | 6 months |