Favipiravir in High-risk COVID-19 Patients

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04818320
• Other study ID #: Favirpiravir-A1
• Status: Completed
• Phase: Phase 3
• Start date: February 16, 2021
• Est. completion date: July 13, 2021

Study information

• Verified date: November 2021
• Source: Penang Hospital, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 13, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Malaysia	Penang General Hospital	George Town	Pulau Pinang

Sponsors (20)

Lead Sponsor

Collaborator

Penang Hospital, Malaysia

Enche' Besar Hajjah Khalsom Hospital, Hulu Terrengganu Hospital, Institute for Clinical Research, 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, Tawau Hospital, Tengku Ampuan Afzan Hospital, The Queen Elizabeth Hospital, Tuanku Fauziah Hospital, Tuanku Jaafar Hospital, Tumpat Hospital

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in the number of patients admitted to ICU		Day of discharge/day 28 of treatment (if still hospitalized)
Secondary	Difference in the number of patients requiring mechanical ventilation		Day of discharge/day 28 of treatment (if still hospitalized)
Secondary	Changes in the length of ICU stay		Day of discharge/day 28 of treatment (if still hospitalized)
Secondary	Changes in in-hospital mortality rate		Day of discharge/day 28 of treatment (if still hospitalized)