Safety and efficacy of Favipiravir

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 - Favipiravir Clinical Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-006042-39-HU

Enrollment

120

Registered

2021-01-12

Start date

2021-02-19

Completion date

Unknown

Last updated

2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with PCR confirmed SARS-CoV-2 infection who are asymptomatic or have mild symptoms will be enrolled MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Favipiravir HU 200 mg hard capsules Product Name: Favipiravir HU 200 mg hard capsules Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of administ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 Signed Informed Consent Form and Patient Information Leaflet Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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 immunosuppressant 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the efficacy of Favipiravir-HU compared to placebo as add-on treatment on reducing SARS-CoV-2 virus copy number as measured by quantitative PCR by nasopharyngeal sampling.;Secondary Objective: Key secondary objectives • To assess the study treatment’s effect on reduction of the time required for virus elimination. • To assess the study treatment’s risk reduction effect. • To assess the recovery time in patients who have developed symptoms, using clinical and radiological diagnostics • To evaluate the safety and tolerability of the investigational product. Secondary objectives • To assess the study treatment’s risk reduction effect on overall mortality. • To assess the study treatment’s risk reduction effect on achieving development of respiratory failure. • To assess the study treatment’s risk reduction effect on need for intensive care unit. • To assess the study treatment’s risk reduction effect on need for non-invasive respiratory support. • To assess the study treatment’s risk reduction effect on need for invasive respiratory support. • To assess the study treatment’s risk reduction effect on Acute Respiratory Distress Syndrome. ;Primary end point(s): The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline. ;Timepoint(s) of evaluation of this end point: Day6 of the study	—

Measure

Time frame

Main Objective: The primary objective is to assess the efficacy of Favipiravir-HU compared to placebo as add-on treatment on reducing SARS-CoV-2 virus copy number as measured by quantitative PCR by nasopharyngeal sampling.;Secondary Objective: Key secondary objectives • To assess the study treatment’s effect on reduction of the time required for virus elimination. • To assess the study treatment’s risk reduction effect. • To assess the recovery time in patients who have developed symptoms, using clinical and radiological diagnostics • To evaluate the safety and tolerability of the investigational product. Secondary objectives • To assess the study treatment’s risk reduction effect on overall mortality. • To assess the study treatment’s risk reduction effect on achieving development of respiratory failure. • To assess the study treatment’s risk reduction effect on need for intensive care unit. • To assess the study treatment’s risk reduction effect on need for non-invasive respiratory support. • To assess the study treatment’s risk reduction effect on need for invasive respiratory support. • To assess the study treatment’s risk reduction effect on Acute Respiratory Distress Syndrome. ;Primary end point(s): The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline. ;Timepoint(s) of evaluation of this end point: Day6 of the study

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Secondary

Measure	Time frame
Secondary end point(s): Time to virus elimination: number of days from treatment start to virus elimination Proportion of patients achieving more severe stages of COVID-19 Time to recovery in patients who have developed symptoms Number and proportion of patients with at least 1 adverse event related to study treatment Secondary endpoints of the study are as follows: Overall mortality rate Proportion of patients with respiratory failure Proportion of patients with need for intensive care Proportion of patients with need for non-invasive respiratory support Proportion of patients with need for invasive respiratory support Proportion of patients with Acute Respiratory Distress Syndrome ;Timepoint(s) of evaluation of this end point: Day28 -last visit	—

Measure

Time frame

Secondary end point(s): Time to virus elimination: number of days from treatment start to virus elimination Proportion of patients achieving more severe stages of COVID-19 Time to recovery in patients who have developed symptoms Number and proportion of patients with at least 1 adverse event related to study treatment Secondary endpoints of the study are as follows: Overall mortality rate Proportion of patients with respiratory failure Proportion of patients with need for intensive care Proportion of patients with need for non-invasive respiratory support Proportion of patients with need for invasive respiratory support Proportion of patients with Acute Respiratory Distress Syndrome ;Timepoint(s) of evaluation of this end point: Day28 -last visit

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Countries

Hungary

Contacts

Public ContactCRO

AdWare Research Ltd.

krisztina.hracs@adwareresearch.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026