Clinical trial NCT04818320: Favipiravir in High-risk COVID-19 Patients
Official title: Efficacy of Favipiravir in High Risk COVID-19 Patients: A Randomised, Open-label, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Lead sponsor: Penang Hospital, Malaysia
Sponsor class: OTHER_GOV
Collaborators: name: Enche' Besar Hajjah Khalsom Hospital
name: Jasin Hospital
name: Kepala Batas Hospital
name: Melaka Hospital
name: Permai Hospital
name: The Queen Elizabeth Hospital
name: Raja Perempuan Zainab II Hospital
name: Raja Permaisuri Bainun Hospital
name: Sultanah Aminah Hospital
name: Hospital Sultanah Nur Zahirah, Kuala Terengganu
name: Sungai Buloh Hospital
name: Tampin Hospital
name: Tengku Ampuan Afzan Hospital
name: Tuanku Fauziah Hospital
name: Tuanku Jaafar Hospital
name: Tumpat Hospital
name: Institute for Clinical Research
name: Tawau Hospital
name: Hulu Terrengganu Hospital
First posted: 2021-03-26
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Need for oxygen supplement
timeFrame: Day of discharge/day 28 of treatment (if still hospitalized)
Secondary outcomes:
measure: Difference in the number of patients admitted to ICU
timeFrame: Day of discharge/day 28 of treatment (if still hospitalized)
measure: Difference in the number of patients requiring mechanical ventilation
timeFrame: Day of discharge/day 28 of treatment (if still hospitalized)
measure: Changes in the length of ICU stay
timeFrame: Day of discharge/day 28 of treatment (if still hospitalized)
measure: Changes in in-hospital mortality rate
timeFrame: Day of discharge/day 28 of treatment (if still hospitalized)
Other outcomes:
Locations:
city: George Town
country: Malaysia
facility: Penang General Hospital
state: Pulau Pinang
Study officials:
References:
citation: 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.