Study to Assess the Efficacy and Safety of Favipiravir-HU

Phase 2

Terminated

• Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
• Interventions: Drug: Placebo HU; Drug: Favipiravir HU 200 mg hard capsules

• Registration Number: NCT04940871
• Lead Sponsor: University of Pecs

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-28
• Study Start: 2021-11-25
• Primary Completion: 2021-11-29
• Study Completion: 2021-11-29
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo HU + SOC	Placebo HU	Placebo HU + SOC
Favipiravir HU + SOC	Favipiravir HU 200 mg hard capsules	Favipiravir HU + SOC

Primary Outcome Measures

Name	Time	Method
PRIM1_ the percentage of virus copy number	5 months	The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Szeged - Internal Medicine; 🇭🇺 Szeged, Hungary