Study to Assess the Efficacy and Safety of Favipiravir-HU

• Sponsor: University of Pecs (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04940871
• Collaborator: Hungarian Ministry of Innovation and Technology (Other)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 18

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)	Drug: Favipiravir HU 200 mg hard capsules; Drug: Placebo HU	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: double-blinded
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. SEC1_mortality rate [6 months]

   Overall mortality rate

2. SEC2_respiratory failure [6 months]

   Proportion of patients with respiratory failure

3. SEC3_ intensive care [6 months]

   Proportion of patients with need for intensive care

4. SEC4_non-invasive respiratory support [6 months]

   Proportion of patients with need for non-invasive respiratory support

5. SEC5_ invasive respiratory support [6 months]

   Proportion of patients with need for invasive respiratory support

6. SEC6_ Acute Respiratory Distress Syndrome [6 months]

   Proportion of patients with Acute Respiratory Distress Syndrome

Other Outcome Measures

1. KSEC1_Time to virus elimination [5 months]

   Number of days from treatment start to virus elimination

2. KSEC2_severe stages of COVID-19 [6 months]

   Proportion of patients achieving more severe stages of COVID-19

3. KSEC3_Time to recovery [6 months]

   Time to recovery in patients who have developed symptoms

4. KSEC4_ adverse event [6 months]

   Number and proportion of patients with at least 1 adverse event related to study treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Pecs
• Hungarian Ministry of Innovation and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pecs
• ClinicalTrials.gov Identifier: NCT04940871
• Other Study ID Numbers: HUN-FAVI-02
• First Posted: Jun 28, 2021
• Last Update Posted: Jun 28, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Severe Acute Respiratory Syndrome; Favipiravir

Study Results

No Results Posted as of Jun 28, 2021