Favipiravir in High-risk COVID-19 Patients

Sponsor

Penang Hospital, Malaysia (Other)

Overall Status

Completed

CT.gov ID

NCT04818320

Collaborator

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

500

Enrollment

Location

Arms

4.8

Actual Duration (Months)

103.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Favipiravir	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 16, 2021

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Jul 13, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penang General Hospital	George Town	Pulau Pinang	Malaysia	10450

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Penang Hospital, Malaysia

ClinicalTrials.gov Identifier:

NCT04818320

Other Study ID Numbers:

Favirpiravir-A1

First Posted:

Mar 26, 2021

Last Update Posted:

Nov 24, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Favipiravir

Study Results

No Results Posted as of Nov 24, 2021