Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2021-02-16
2021-07-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Favipiravir
Favipiravir treatment group (with standard of care),
Favipiravir
Day 1: 1800mg BD, day 2-5: 800mg BD
Control
No favipiravir given. Standard of care only
No interventions assigned to this group
Interventions
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Favipiravir
Day 1: 1800mg BD, day 2-5: 800mg BD
Eligibility Criteria
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Inclusion 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
* 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
50 Years
ALL
No
Sponsors
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Enche' Besar Hajjah Khalsom Hospital
UNKNOWN
Jasin Hospital
UNKNOWN
Kepala Batas Hospital
OTHER_GOV
Melaka Hospital
UNKNOWN
Permai Hospital
UNKNOWN
The Queen Elizabeth Hospital
OTHER
Raja Perempuan Zainab II Hospital
UNKNOWN
Raja Permaisuri Bainun Hospital
UNKNOWN
Sultanah Aminah Hospital
UNKNOWN
Hospital Sultanah Nur Zahirah, Kuala Terengganu
OTHER_GOV
Sungai Buloh Hospital
UNKNOWN
Tampin Hospital
UNKNOWN
Tengku Ampuan Afzan Hospital
UNKNOWN
Tuanku Fauziah Hospital
UNKNOWN
Tuanku Jaafar Hospital
UNKNOWN
Tumpat Hospital
UNKNOWN
Institute for Clinical Research
OTHER
Tawau Hospital
UNKNOWN
Hulu Terrengganu Hospital
UNKNOWN
Penang Hospital, Malaysia
OTHER_GOV
Responsible Party
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Locations
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Penang General Hospital
George Town, Pulau Pinang, Malaysia
Countries
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References
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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.
Other Identifiers
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Favirpiravir-A1
Identifier Type: -
Identifier Source: org_study_id