A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study Evaluating the Efficacy and Safety of Favipiravir in the Treatment of Adult Patients With COVID-19-Moderate Type

Zhejiang Hisun Pharmaceutical Co. Ltd.9 sites in 3 countries256 target enrollmentJune 2020

ConditionsCOVID-19

InterventionsFavipiravir Placebo

DrugsFavipiravir

Overview

Phase: Phase 3
Intervention: Favipiravir
Conditions: COVID-19
Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
Enrollment: 256
Locations: 9
Primary Endpoint: Time from randomization to clinical recovery
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled, phase III clinical study to evaluate the efficacy of Favipiravir combined with supportive care for adult patients with COVID-19-Moderate type.

Registry

clinicaltrials.gov

Start Date

June 2020

End Date

September 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures;
•Age 18-75 years (inclusive) at the time of signing ICF;
•Being confirmed with COVID-19-Moderate type according to Competent Authority and Ministry of Health and respective country guidelines and recommendations reported in Appendix 1 (a, b, c, d) to the present protocol. Based on comprehensive analysis and judgement taking into account both the epidemiological history and clinical manifestations, the diagnosis is to be confirmed for suspected cases or suspected cases/clinically diagnosed cases with all of the following etiological evidences:
•Positivity in RT-PCR 2019-nCov test on respiratory tract specimens;
•High homology with known gene sequence of 2019-nCov in viral gene sequencing on respiratory tract specimens.
•Chest imaging (CT as first option or X-ray if CT not possible)-documented pneumonia; if CT cannot be performed, Pneumonia confirmed by X-ray may be used. The method of chest imaging pneumonia diagnosis must be consistent all through the study period;
•Patients with pyrexia (axillary ≥37℃ or oral ≥ 37.5℃, or tympanic or rectal≥38℃) or either respiratory rate \>24/min and \<30/min or cough; For not hospitalized patients, the Investigator should maintain the detection method consistent through study period. In addition, the Investigator should maintain the data collection and quality compliant with GCP requirements.
•The interval between symptoms onset and randomization is no more than 10 days; symptoms onset is primarily based on pyrexia, and can be based on cough or other related symptoms for patients without experiencing pyrexia following onset (it is strongly recommended that the interval between symptoms onset and randomization should not exceed 5 days);
•For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pre-treatment serum or urine pregnancy test. Menopause is defined as amenorrhea for at least 12 months without other medical cause, with the following age-specific requirements:
•For female subjects aged \<50 years: menopause for at least 12 months following withdrawal of exogenous hormonal therapy, with LH or FSH within the post-menopausal ranges, or having undergone any contraceptive surgery (bilateral oophorectomy or hysterectomy);

Exclusion Criteria

•Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely;
•Refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug or having undergone extensive bowel resection which may affect adequate absorption of Favipiravir;
•Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN;
•Gout/history of gout or hyperuricemia (above the ULN);
•Oxygen saturation (SPO2) ≤93% or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) ≤300 mmHg;
•Known allergy or hypersensitivity to Favipiravir or any of its excipients, or to placebo excipients
•Known severe renal impairment \[creatinine clearance (CrCl) \<30 mL/min\] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
•Possibility of the subject being transferred to a non-study hospital within 72h;
•Pregnant or lactating women;
•Having used Favipiravir or participated in any other interventional drug clinical study within 30 days prior to first dose of study drug or having received treatments with other Investigational Medicinal Products (IMPs) or previous therapies within two weeks or five times the half-life of the drug, whichever is longer, must lead to exclusion

Arms & Interventions

Favipiravir

Favipiravir Tablets, 200 mg/tablet Favipiravir combined with supportive care recommended in the current National/Local guidelines. Favipiravir dosage and method of administration: Day 1: 1800mg, BID; Day 2 and thereafter: 600mg, TID, for a maximum of 14 days.

Intervention: Favipiravir

Placebo

Placebo control group Favipiravir combined with supportive care recommended in the current National/Local guidelines

Intervention: Placebo

Outcomes

Primary Outcomes

Time from randomization to clinical recovery

Time Frame: 28 days

The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory rate and SPO2 and relief of cough (where there are relevant abnormal symptoms at enrolment) that is maintained for at least 72h. Criteria for normalization or relief: * Pyrexia (body temperature): axillary ≤37℃，or oral≤37.5℃，or rectal or tympanic ≤38℃; * Respiratory rate: ≤24/min without oxygen inhalation; * SPO2: \>94% without oxygen inhalation; * Cough: Subject-perceived improvement or resolution of cough.