Study to Assess the Efficacy and Safety of Favipiravir-HU

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

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04940871
• Other study ID #: HUN-FAVI-02
• Status: Terminated
• Phase: Phase 2
• Start date: November 25, 2021
• Est. completion date: November 29, 2021

Study information

• Verified date: November 2022
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Favipiravir HU 200 mg hard capsules
Drug substance: Favipiravir Dose: 200 mg Administration: oral Formulation: capsules
• Placebo HU
Name: Placebo clinical sample Drug substance: placebo Dose: - Administration: oral Formulation: capsules

Locations

Country	Name	City	State
Hungary	University of Szeged - Internal Medicine	Szeged

Sponsors (2)

Lead Sponsor	Collaborator
University of Pecs	Hungarian Ministry of Innovation and Technology

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	KSEC1_Time to virus elimination	Number of days from treatment start to virus elimination	5 months
Other	KSEC2_severe stages of COVID-19	Proportion of patients achieving more severe stages of COVID-19	6 months
Other	KSEC3_Time to recovery	Time to recovery in patients who have developed symptoms	6 months
Other	KSEC4_ adverse event	Number and proportion of patients with at least 1 adverse event related to study treatment	6 months
Primary	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	SEC1_mortality rate	Overall mortality rate	6 months
Secondary	SEC2_respiratory failure	Proportion of patients with respiratory failure	6 months
Secondary	SEC3_ intensive care	Proportion of patients with need for intensive care	6 months
Secondary	SEC4_non-invasive respiratory support	Proportion of patients with need for non-invasive respiratory support	6 months
Secondary	SEC5_ invasive respiratory support	Proportion of patients with need for invasive respiratory support	6 months
Secondary	SEC6_ Acute Respiratory Distress Syndrome	Proportion of patients with Acute Respiratory Distress Syndrome	6 months