Study to Assess the Efficacy and Safety of Favipiravir-HU

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

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.

Study Overview

• Status: Terminated
• Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
• Intervention / Treatment: Drug: Favipiravir HU 200 mg hard capsules; Drug: Placebo HU

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hungary
  • Szeged, Hungary
    • University of Szeged - Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients between the ages of 18 and 65 years.
2. Patients with PCR confirmed SARS-CoV-2 infection
3. Asymptomatic or have mild only symptoms and symptoms are onset less than 5 days
4. Signed Informed Consent Form and Patient Information Leaflet

Exclusion Criteria:

1. Pregnant or possibly pregnant patients or lactating females
2. Patients have moderate to severe or immediately life-threatening COVID-19
3. Major risk factor onset (Obesity, Diabetes, COPD, Hypertension)
4. Patients with SpO2 less than 95% without oxygen therapy
5. Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification
6. Patients with renal impairment requiring dialysis
7. Patients with disturbed consciousness such as disturbed orientation
8. 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
9. 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.
10. Patients with hereditary xanthinuria
11. Patient with severe uncontrolled hyperuricaemia
12. Patients receiving immunosuppressants
13. 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
14. Any medical condition that the examining physician deems unsuitable for the patient to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
KSEC1_Time to virus elimination	Number of days from treatment start to virus elimination	5 months
KSEC2_severe stages of COVID-19	Proportion of patients achieving more severe stages of COVID-19	6 months
KSEC3_Time to recovery	Time to recovery in patients who have developed symptoms	6 months
KSEC4_ adverse event	Number and proportion of patients with at least 1 adverse event related to study treatment	6 months

Collaborators and Investigators

• Sponsor: University of Pecs
• Collaborators: Hungarian Ministry of Innovation and Technology

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Actual): November 29, 2021
• Study Completion (Actual): November 29, 2021

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome; Anti-Infective Agents; Antiviral Agents; Favipiravir
• Other Study ID Numbers: HUN-FAVI-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No