Covid19Phase 3NCT04818320
Favipiravir in High-risk COVID-19 Patients
A Phase 3 study testing Favipiravir in people with Covid19, run by Penang Hospital, Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Favipiravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteMalaysia
- Study dates
- 16 Feb 2021to 13 Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Favipiravir in High Risk COVID-19 Patients: A Randomised, Open-label, Multicenter Clinical Trial
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.
- Conditions
- Covid19
- Being tested
- Favipiravir
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Day 1: 1800mg BD, day 2-5: 800mg BD
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir | Experimental | Favipiravir treatment group (with standard of care), Receives: Drug: Favipiravir |
| Control | No intervention | No favipiravir given. Standard of care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for oxygen supplement
Drop in SPO2 in room air to <95% or requiring supplemental oxygen to maintain SPO2≥95%
Measured: Day of discharge/day 28 of treatment (if still hospitalized)
Secondary outcomes (4)
Difference in the number of patients admitted to ICU
Measured: Day of discharge/day 28 of treatment (if still hospitalized)
Difference in the number of patients requiring mechanical ventilation
Measured: Day of discharge/day 28 of treatment (if still hospitalized)
Changes in the length of ICU stay
Measured: Day of discharge/day 28 of treatment (if still hospitalized)
Changes in in-hospital mortality rate
Measured: Day of discharge/day 28 of treatment (if still hospitalized)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start16 Feb 2021
- Primary completion1 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penang Hospital, Malaysia
- Sponsor type
- Other government
- Collaborators
- Enche' Besar Hajjah Khalsom Hospital, Jasin Hospital, Kepala Batas Hospital, Melaka Hospital, Permai Hospital, The Queen Elizabeth Hospital, Raja Perempuan Zainab II Hospital, Hospital Raja Permaisuri Bainun, 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818320
- Sponsor's protocol ID
- Favirpiravir-A1
- Status last verified
- Nov 2021
- First submitted
- 24 Mar 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34849615
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Favipiravir in High Risk COVID-19 Patients: A Randomised, Open-label, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04818320
- Acronym / sponsor ID
- Favirpiravir-A1
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Penang Hospital, MalaysiaOther government
- Collaborators
- Enche' Besar Hajjah Khalsom Hospital, Jasin Hospital, Kepala Batas Hospital, Melaka Hospital, Permai Hospital, The Queen Elizabeth Hospital, Raja Perempuan Zainab II Hospital, Hospital Raja Permaisuri Bainun, 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
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Favipiravir | Experimental | Drug: FavipiravirFavipiravir treatment group (with standard of care), |
| Control | No intervention | –No favipiravir given. Standard of care only |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FavipiravirDay 1: 1800mg BD, day 2-5: 800mg BD | Drug | Favipiravir |
Primary outcome
Need for oxygen supplement
Time frame: 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%
4 secondary outcomes
Difference in the number of patients admitted to ICU
Time frame: Day of discharge/day 28 of treatment (if still hospitalized)
Difference in the number of patients requiring mechanical ventilation
Time frame: Day of discharge/day 28 of treatment (if still hospitalized)
Changes in the length of ICU stay
Time frame: Day of discharge/day 28 of treatment (if still hospitalized)
Changes in in-hospital mortality rate
Time frame: Day of discharge/day 28 of treatment (if still hospitalized)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Derived from this study: PubMed 34849615Chuah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Favipiravir in people with Covid19, run by Penang Hospital, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for oxygen supplement (time frame: Day of discharge/day 28 of treatment (if still hospitalized)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04818320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.