Covid19
Conditions
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.
Interventions
DRUGFavipiravir
Day 1: 1800mg BD, day 2-5: 800mg BD
Sponsors
Enche' Besar Hajjah Khalsom Hospital
Jasin Hospital
Kepala Batas Hospital
Melaka Hospital
Permai Hospital
The Queen Elizabeth Hospital
Raja Perempuan Zainab II Hospital
Raja Permaisuri Bainun Hospital
Sultanah Aminah Hospital
Hospital Sultanah Nur Zahirah, Kuala Terengganu
Sungai Buloh Hospital
Tampin Hospital
Tengku Ampuan Afzan Hospital
Tuanku Fauziah Hospital
Tuanku Jaafar Hospital
Tumpat Hospital
Institute for Clinical Research
Tawau Hospital
Hulu Terrengganu Hospital
Penang Hospital, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
Countries
Malaysia
Outcome results
None listed