Favipiravir in High-risk COVID-19 Patients

Efficacy of Favipiravir in High Risk COVID-19 Patients: A Randomised, Open-label, Multicenter Clinical Trial

The study aims to investigate the efficacy of favipiravir in high-risk COVID-19 patients. The study population includes symptomatic mild-to-moderate COVID-19 inpatients, within first 7 days of illness, who are 50 years old and above, and have 1 or more comorbidities. The study is designed as a randomised, open-label, multicenter clinical trial where the patients are randomised 1:1 to groups receiving favipiravir (5 days) versus no favipiravir.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Favipiravir

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Malaysia
  • Pulau Pinang
    • George Town, Pulau Pinang, Malaysia, 10450
      • Penang General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients are eligible to be included in the study only if they fulfil ALL the following criteria:
• RT-PCR confirmed COVID-19 cases
• Aged 50 years and above, AND have one or more co-morbidities
• Within the first 7 days of illness (from symptom onset)
• Mild to moderate clinical severity

Exclusion Criteria:

• Asymptomatic stage 1 patients
• Patients with SpO2 less than 95% without oxygen therapy
• Patients who needs oxygen supplements
• Patients with concomitant bacterial or fungal infection (confirmed by culture) prior to initiation of study
• Patients with congestive heart failure
• Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal limit)
• Impaired kidney function (creatinine clearance according to Cockcroft-Gault formula less than 30 ml/min) at the time of screening.
• Malabsorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
• Pregnant or nursing women or women planning pregnancy.
• Female patients who cannot consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of favipiravir administration to 7 days after the end of favipiravir administration
• Male patients whose partner cannot agree to use the contraception method described in (9)
• Patients with a history of gout or on treatment for gout or hyperuricemia
• Patients receiving immunosuppressants
• Patients who received interferon or drugs with reported antiviral activity against COVID-19 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination) within 7 days of illness.
• Patients in whom this episode of infection is a recurrence or reinfection of COVID-19 infection
• Patients who have previously received favipiravir
• Patients who are not able to provide written consent by themselves
• Other patients judged ineligible by the principal investigator or sub-investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Favipiravir; Favipiravir treatment group (with standard of care),	Drug: Favipiravir; Day 1: 1800mg BD, day 2-5: 800mg BD
No Intervention: Control; No favipiravir given. Standard of care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for oxygen supplement	Drop in SPO2 in room air to <95% or requiring supplemental oxygen to maintain SPO2≥95%	Day of discharge/day 28 of treatment (if still hospitalized)

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in the number of patients admitted to ICU	Day of discharge/day 28 of treatment (if still hospitalized)
Difference in the number of patients requiring mechanical ventilation	Day of discharge/day 28 of treatment (if still hospitalized)
Changes in the length of ICU stay	Day of discharge/day 28 of treatment (if still hospitalized)
Changes in in-hospital mortality rate	Day of discharge/day 28 of treatment (if still hospitalized)

Collaborators and Investigators

• Sponsor: Penang Hospital, Malaysia
• Collaborators: The Queen Elizabeth Hospital; Enche' Besar Hajjah Khalsom Hospital; Jasin Hospital; Kepala Batas Hospital; Melaka Hospital; Permai Hospital; Raja Perempuan Zainab II Hospital; Raja Permaisuri Bainun Hospital; Sultanah Aminah Hospital; Sultanah Nur Zahirah Hospital; Sungai Buloh Hospital; Tampin Hospital; Tengku Ampuan Afzan Hospital; Tuanku Fauziah Hospital; Tuanku Jaafar Hospital; Tumpat Hospital; Institute for Clinical Research; Tawau Hospital; Hulu Terrengganu Hospital

Publications and helpful links

General Publications

• Chuah CH, Chow TS, Hor CP, Cheng JT, Ker HB, Lee HG, Lee KS, Nordin N, Ng TK, Zaid M, Zaidan NZ, Abdul Wahab S, Adnan NA, Nordin N, Tee TY, Ong SM, Chidambaram SK, Mustafa M; Malaysian Favipiravir Study Group. Efficacy of Early Treatment With Favipiravir on Disease Progression Among High-Risk Patients With Coronavirus Disease 2019 (COVID-19): A Randomized, Open-Label Clinical Trial. Clin Infect Dis. 2022 Aug 24;75(1):e432-e439. doi: 10.1093/cid/ciab962.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 13, 2021

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Favipiravir
• Other Study ID Numbers: Favirpiravir-A1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No