Favipiravir in High-risk COVID-19 Patients

NCT04818320 | Completed Phase 3

• 1 other identifier: Favirpiravir-A1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

Study Arms (2)

Favipiravir

EXPERIMENTAL

Favipiravir treatment group (with standard of care),

Drug: Favipiravir

Control

NO INTERVENTION

No favipiravir given. Standard of care only

Interventions

Favipiravir DRUG

Day 1: 1800mg BD, day 2-5: 800mg BD

Favipiravir

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Penang General Hospital

George Town, Pulau Pinang, 10450, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 34849615 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

favipiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: February 16, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 13, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)