Study to Assess the Efficacy and Safety of Favipiravir-HU

NCT04940871 | Terminated Phase 2 DMC

• 1 other identifier: HUN-FAVI-02
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• SEC1_mortality rate

  6 months

• SEC2_respiratory failure

  6 months

• SEC3_ intensive care

  6 months

• SEC4_non-invasive respiratory support

  6 months

• SEC5_ invasive respiratory support

  6 months

Other Outcomes (4)

• KSEC1_Time to virus elimination

  5 months

• KSEC2_severe stages of COVID-19

  6 months

• KSEC3_Time to recovery

  6 months

Study Arms (2)

Favipiravir HU + SOC

EXPERIMENTAL

Favipiravir HU + SOC

Drug: Favipiravir HU 200 mg hard capsules

Placebo HU + SOC

PLACEBO COMPARATOR

Placebo HU + SOC

Drug: Placebo HU

Interventions

Favipiravir HU 200 mg hard capsules DRUG

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

Favipiravir HU + SOC

Placebo HU DRUG

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

Placebo HU + SOC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pecs: lead
• Hungarian Ministry of Innovation and Technology: collaborator

Study Sites (1)

University of Szeged - Internal Medicine

Szeged, Hungary

Location

MeSH Terms

Interventions

Hardness

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 28, 2021
• Study Start: November 25, 2021
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

HU (1)