Favipiravir in High-risk COVID-19 Patients

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Penang Hospital, Malaysia
• Collaborators: Enche' Besar Hajjah Khalsom 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; Tengku Ampuan Afzan Hospital; The Queen Elizabeth Hospital; Tuanku Fauziah Hospital; Tuanku Jaafar Hospital; Tumpat Hospital
• Treatments: Favipiravir

Criteria

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