Study to Assess the Efficacy and Safety of Favipiravir-HU

NCT ID: NCT04940871

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-25
• Study Completion Date: 2021-11-29

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Favipiravir HU + SOC

Favipiravir HU + SOC

Group Type: EXPERIMENTAL

Favipiravir HU 200 mg hard capsules

Intervention Type: DRUG

Drug substance: Favipiravir Dose: 200 mg Administration: oral Formulation: capsules

Placebo HU + SOC

Placebo HU + SOC

Group Type: PLACEBO_COMPARATOR

Placebo HU

Intervention Type: DRUG

Name: Placebo clinical sample Drug substance: placebo Dose: - Administration: oral Formulation: capsules

Interventions

Favipiravir HU 200 mg hard capsules

Drug substance: Favipiravir Dose: 200 mg Administration: oral Formulation: capsules

Intervention Type: DRUG

Placebo HU

Name: Placebo clinical sample Drug substance: placebo Dose: - Administration: oral Formulation: capsules

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hungarian Ministry of Innovation and Technology

UNKNOWN

Sponsor Role: collaborator

University of Pecs

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Szeged - Internal Medicine

Szeged, , Hungary

Countries

Hungary

Other Identifiers

HUN-FAVI-02

Identifier Type: -

Identifier Source: org_study_id