Covid19Phase 3NCT05014373
Philippine Trial to Determine Efficacy and Safety of Favipiravir for COVID-19
A Phase 3 study of Covid19, run by University of the Philippines at 1 site in Philippines.
Trial summary
This is an open label randomized controlled clinical trial which was designed to confirm the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Covid19
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 sitePhilippines
- Study dates
- 12 Oct 2020to 31 Aug 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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 74 years (at the time of informed consent)
- Gender: Male or female
- Patients with SARS-CoV-2-positive nasopharyngeal swab by RT-PCR test with non-severe presentation upon admission to clinical trial site hospitals or trial-supervised quarantine facilities or under trial -supervised home isolation;
- For premenopausal female patients, patients who have been confirmed to be negative on a pregnancy test before administration of the study drug;
- Patients who understand the contents of this study and can provide written consent by themselves without assistance, or as appropriate with their assent and consent of their parents
Who cannot join
- Patient has manifestation that meets case definition of Severe COVID-19: Adult with clinical signs of pneumonia (fever, cough, dyspnea, fast breathing) plus one of the following: respiratory rate > 30 breaths/min; severe respiratory distress; or SpO2 < 90% on room air.
- Fever (37.5°C) more than 7 days after the onset of fever
- Patients with suspected concomitant bacterial infections (e.g. 1 ng/ml or higher procalcitonin, etc.) prior to initiation of study drug
- Patients with suspected concomitant fungal infections (e.g. 30 pg/ml or higher (1-3)-β-d-glucan, etc.) prior to initiation of study drug
- Patients with suspected concurrent congestive heart failure (e.g. 100 pg/mL or higher NT-pro BNP levels, etc.) prior to initiation of study drug
- Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal limit)
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- Patients with renal impairment requiring dialysis
- Patients with disturbed consciousness such as disturbed orientation
- Pregnant or possibly pregnant patients
- Female patients who are unable to consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices during the 7 days after the start of favipiravir administration.
- Male patients whose partner cannot agree to use the contraception method described in (10) above
- Patients who cannot consent to the use of condoms from the start of favipiravir administration to 7 days after the end of favipiravir administration
- Patients with hereditary xanthinuria
- Patients who have previously ever been diagnosed with hypouricemia (< 1 mg/dL) or xanthine urinary calculi
- Patients with a history of gout or on treatment for gout or hyperuricemia
- Patients receiving immunosuppressants
- Patients who received interferon-alpha or drugs with reported antiviral activity against SARS-CoV-2 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate) within 9 days after fever (37.5°C or more).
- Patients in whom this episode of infection is a recurrence or reinfection of SARS-CoV-2 infection
- Patients who have previously received favipiravir (T-705a)
- Other patients judged ineligible by the principal investigator or sub-investigator
Trial locations and contacts
1 site in 1 country.
Philippines1 site, 1 recruiting
- Recruiting
Dr. Regina Berba
Manila, National Capital Region, 1000
Regina P Berba, MD, +639985381599, rpberba@gmail.com
About this study
Official title: An Investigation of the Efficacy and Safety of Favipiravir in Hospitalized NON- SEVERE COVID-19 Patients - An Open-label Randomized Controlled Multi Center Trial
This is an open label randomized controlled clinical trial which was designed to confirm the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care.
Read the detailed description
Favipiravir is an antiviral agent whose indication in Japan is currently for influenza infections. There were earlier reports from China suggesting its promising potential for benefit in the treatment of COVID-19. This is an open label randomized controlled clinical trial was designed to verify the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care. This study will look at the potential of using this repurposed oral agent in managing non-severe cases of COVID19. Consenting patients admitted to hospitals or isolation/quarantine facilities will be randomized at a 2:1 ratio to either favipiravir versus best supportive care. Patients will be examined daily and will have xray and nasopharyngeal swabs every 3-4 days for close monitoring.
- Conditions
- Covid19
- Being tested
- Favipiravir + Standard of Care, Standard of Care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Favipiravir + Standard of CareCombination product
1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
Plus Standard of Care
Standard of CareProcedure or surgery
Best supportive care includes Standard treatment included oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs \& the medication any patient is on due to any concomitant diseases.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Favipiravir + Best supportive Care | Active comparator | Favipiravir (or Avigan) 1800 mg tablet 2x a day on Day 1 then 800 mg 2x a day from Day 2 to maximum of Day 14 Receives: Combination Product: Favipiravir + Standard of Care; Procedure: Standard of Care |
| Comparator: Best Supportive Care | Placebo comparator | Best supportive care or Standard Treatment includes oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs \& the medication any patient is on due to any concomitant diseases Receives: Combination Product: Favipiravir + Standard of Care; Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from initiation of treatment to clinical improvement
The duration from start of treatment (Favipiravir + Standard of care compared to Standard of care) to clinical improvement and maintained for at least 48 hours.
Criteria for clinical improvement include all three must be reached:
Body temperature: axillary ≤37.4°C
Oxygen saturation measured by pulse oximeter of >96% without oxygen inhalation
Chest imaging findings with changes showing improvement
Measured: 4 to 28 days
Secondary outcomes (4)
Clinical effect of Favipiravir + Standard of Care compared to Standard of Care on patient status as measured by 7-point scale
Change in the study specific seven-point scale from initiation of treatment to end of treatment
Measured: 4 to 14 days of therapy
Number of participants with conversion to negative level of SARS-COV2 viral genome
Number of participants with conversion to negative level of SARS-COV2 viral genome
Measured: 4 to 14 days of therapy
Number of participants with Changes in NEWS (National Early Warning Score)
Number of participants with Changes in NEWS (National Early Warning Score)
Measured: 4 to 14 days of therapy
Number of participants with improvement in chest imaging findings
Number of participants with improvement in chest imaging findings
Measured: 4 to 14 days of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start12 Oct 2020
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Philippines
- Responsible party
- Sponsor
- Investigators
- Regina. Berba., MD, Principal investigator, Philippine General Hospital, Manila Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014373
- Sponsor's protocol ID
- SJREB 2020-34
- Status last verified
- Aug 2021
- First submitted
- 14 Jun 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Efficacy and Safety of Favipiravir in Hospitalized NON- SEVERE COVID-19 Patients - An Open-label Randomized Controlled Multi Center Trial
- ClinicalTrials.gov ID
- NCT05014373
- Acronym / sponsor ID
- SJREB 2020-34
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Collaborators
- Department of Health, Philippines
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 20 Aug 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.
This is an open label randomized controlled clinical trial which was designed to confirm the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care.
Detailed description
Favipiravir is an antiviral agent whose indication in Japan is currently for influenza infections. There were earlier reports from China suggesting its promising potential for benefit in the treatment of COVID-19. This is an open label randomized controlled clinical trial was designed to verify the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care. This study will look at the potential of using this repurposed oral agent in managing non-severe cases of COVID19. Consenting patients admitted to hospitals or isolation/quarantine facilities will be randomized at a 2:1 ratio to either favipiravir versus best supportive care. Patients will be examined daily and will have xray and nasopharyngeal swabs every 3-4 days for close monitoring.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Favipiravir + Best supportive Care | Active comparator | Combination Product: Favipiravir + Standard of Care, Procedure: Standard of CareFavipiravir (or Avigan) 1800 mg tablet 2x a day on Day 1 then 800 mg 2x a day from Day 2 to maximum of Day 14 |
| Comparator: Best Supportive Care | Placebo comparator | Combination Product: Favipiravir + Standard of Care, Procedure: Standard of CareBest supportive care or Standard Treatment includes oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs \& the medication any patient is on due to any concomitant diseases |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 to 74 years (at the time of informed consent)
- Gender: Male or female
- Patients with SARS-CoV-2-positive nasopharyngeal swab by RT-PCR test with non-severe presentation upon admission to clinical trial site hospitals or trial-supervised quarantine facilities or under trial -supervised home isolation;
- For premenopausal female patients, patients who have been confirmed to be negative on a pregnancy test before administration of the study drug;
- Patients who understand the contents of this study and can provide written consent by themselves without assistance, or as appropriate with their assent and consent of their parents
Key exclusion criteria (20 listed)
- Patient has manifestation that meets case definition of Severe COVID-19: Adult with clinical signs of pneumonia (fever, cough, dyspnea, fast breathing) plus one of the following: respiratory rate > 30 breaths/min; severe respiratory distress; or SpO2 < 90% on room air.
- Fever (37.5°C) more than 7 days after the onset of fever
- Patients with suspected concomitant bacterial infections (e.g. 1 ng/ml or higher procalcitonin, etc.) prior to initiation of study drug
- Patients with suspected concomitant fungal infections (e.g. 30 pg/ml or higher (1-3)-β-d-glucan, etc.) prior to initiation of study drug
- Patients with suspected concurrent congestive heart failure (e.g. 100 pg/mL or higher NT-pro BNP levels, etc.) prior to initiation of study drug
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 |
|---|---|---|
| Favipiravir + Standard of Care1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily Plus Standard of Care | Combination product | Comparator: Best Supportive Care, Experimental: Favipiravir + Best supportive Care |
| Standard of CareBest supportive care includes Standard treatment included oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs \& the medication any patient is on due to any concomitant diseases. | Procedure or surgery | Comparator: Best Supportive Care, Experimental: Favipiravir + Best supportive Care |
Primary outcome
Time from initiation of treatment to clinical improvement
Time frame: 4 to 28 days
The duration from start of treatment (Favipiravir + Standard of care compared to Standard of care) to clinical improvement and maintained for at least 48 hours. Criteria for clinical improvement include all three must be reached: Body temperature: axillary ≤37.4°C Oxygen saturation measured by pulse oximeter of >96% without oxygen inhalation Chest imaging findings with changes showing improvement
4 secondary outcomes
Clinical effect of Favipiravir + Standard of Care compared to Standard of Care on patient status as measured by 7-point scale
Time frame: 4 to 14 days of therapy
Number of participants with conversion to negative level of SARS-COV2 viral genome
Time frame: 4 to 14 days of therapy
Number of participants with Changes in NEWS (National Early Warning Score)
Time frame: 4 to 14 days of therapy
Number of participants with improvement in chest imaging findings
Time frame: 4 to 14 days of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
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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.
Regina. Berba., MD principal investigator
Philippine General Hospital, Manila Philippines
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 of Covid19, run by University of the Philippines at 1 site in Philippines.
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 20 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: status not confirmed, as of the sponsor's last update on 20 Aug 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 Philippines. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Regina Berba, MD (+639985381599, rpberba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from initiation of treatment to clinical improvement (time frame: 4 to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2021.