Coronavirus Disease (COVID-19)Phase 3FAV-001NCT04349241
Efficacy and Safety of Favipiravir in Management of COVID-19
A Phase 3 study testing favipiravir in people with Coronavirus Disease (COVID-19), run by Ain Shams University at 1 site in Egypt.
Trial summary
Randomized controlled interventional trial (Clinical Trial) phase 3 to assess the safety and efficacy of favipiravir versus the standard care therapy in the treatment of patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronavirus Disease (COVID-19)
- What is being tested?
- favipiravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Apr 2020to 20 Jun 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 80 years.
- Patients with confirmed COVID-19 documented by a diagnostic laboratory test (e.g., nasopharyngeal swab) at the time of illness.
- And Have mild to moderate symptoms according to the national protocol classification of patients.
Who cannot join
- Patients have severe or immediately life-threatening COVID-19, Severe disease is defined as: dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours Life-threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure
- Pregnant or lactating females.
- Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, 11566
About this study
Randomized controlled interventional trial (Clinical Trial) phase 3 to assess the safety and efficacy of favipiravir versus the standard care therapy in the treatment of patients with COVID-19.
Read the detailed description
Study Procedures:
Screening phase:
- Obtaining an informed consent
- Written signed and dated informed consent will be obtained from each patient before being entered into the study. The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial. This will be obtained from each subject in accordance with the recommendation of the revised Declaration of Helsinki. The investigator will explain the nature, purpose and risks of the study. It will be clearly stated that the patient is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal.
- In case the patient is unable to provide his/her consent the legal guardian will give verbal approval on behaves of the patient and after he he/she will be well informed by the study design, procedure, risk and benefits over phone call.
- If it is difficult to reach the legal guardian, emergency approval will be obtained by Professional Legal Representative who will be the head authorities of the isolation hospital.
- Full medical history, concurrent medications, demographic data will be obtained.
- A thorough physical examination will be performed.
- Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and Blood oxygen saturation) will be recorded.
- Chest X-ray or CT chest will be recorded.
- Laboratory to perform the following tests:
Complete blood count with differential counts, COVID -19 PCR test by nasopharyngeal swab. C-reactive protein and serum ferritin level. Renal function tests (RFTs) (serum creatinine), Liver function tests (LFTs) (alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin), Coagulation test; prothrombin time and INR. HIV antibody, HCV antibody and HBV surface antigen (HBsAg). Urine pregnancy test for females.
Treatment phase for eligible patients:
- Eligibility confirmed
- The patient will receive information regarding the treatment duration, how to take the study treatment and the dose of the study treatment.
- The patient will receive information regarding the identification and notification of adverse events as diarrhea that occurs in about 25 % of patients and mild elevation of transaminases.
- The patient will be advised to record the daily dosing of study medications that were taken in diaries. If the patient is fatigued or uneducated the clinical pharmacist or the treating physician will be responsible for recording.
- Concomitant medications will also be recorded.
- Eligible patients in group 1 will be given favipiravir in a regimen of 3200 mg (1600 mg 12 hourly) loading dose on day-1 followed by 1200 mg maintenance dose (600 mg 12 hourly daily) on day-2 to day-10.
- Eligible patients in group 2 will receive oseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10.
- Clinical assessment will be performed on days 3 and 7 and adverse events will be recorded.
- Laboratory follow up: Days 3 and 7 of treatment
- Liver function tests (ALT and AST).
- COVID -19 PCR test by nasopharyngeal swab.
- C-reactive protein and serum ferritin levels. End point of the study: Day 14 assessment
- The patient's health status and the presence of adverse events will be assessed.
- Complete physical examination.
- Vital signs (blood pressure, heart rate and temperature) will be recorded.
- Follow-up CXR and /or CT scan.
- Liver function tests (LFTs) (alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin).
- C-reactive protein and serum ferritin level.
- COVID -19 PCR test by nasopharyngeal swab
- Post treatment period up to 30 days after end of treatment:
- Vital signs (blood pressure, heart rate and temperature) will be recorded.
- Symptoms and signs assessment will be done.
- Conditions
- Coronavirus Disease (COVID-19)
- Being tested
- favipiravir, Standard of care therapy
- 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
Also called pyrazine carboxamide derivative
pyrazine carboxamide derivative (6-fluoro-3-hydroxy-2-pyrazinecarboxamide), a new type of RNA-dependent RNA polymerase (RdRp) inhibitor
Standard of care therapyDrug
Also called National Egyptian guideline
oseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10
| Study group | Role | What they receive |
|---|---|---|
| favipiravir | Experimental | favipiravir in a regimen of 3200 mg (1600 mg 12 hourly) loading dose on day-1 followed by 1200 mg maintenance dose (600 mg 12 hourly daily) on day-2 to day-10 Receives: Drug: favipiravir |
| Standard of care therapy | Active comparator | oseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10. Receives: Drug: Standard of care therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral clearance
Two successive negative COVID-19 PCR analysis tests 48-72 hours apart
Measured: 14 days
Clinical improvement
Normal body temperature for 48 hours
Measured: 14 days
Secondary outcomes (1)
Radiological Improvement
Improvement of radiological abnormalities at day 14
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start18 Apr 2020
- Primary completion1 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease (COVID-19)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Model description
- A block-randomization scheme will be generated by computer software. 100 patients with confirmed COVID-19 will be randomized between favipiravir and the standard of care therapy (treated according to the national protocol) in a 1:1 ratio. Group 1: 50 patients will receive the investigational drug favipiravir. Group 2: 50 patients will receive oseltamivir and hydroxychloroquine as the national standard of care therapy.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Dabbous, Ain Shams University
- Investigators
- Hany Dabbous, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349241
- Sponsor's protocol ID
- FMASU P14 / 2020
- Acronym
- FAV-001
- Status last verified
- Jun 2020
- First submitted
- 13 Apr 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Favipiravir in Management of COVID-19
- ClinicalTrials.gov ID
- NCT04349241
- Acronym / sponsor ID
- FAV-001 / FMASU P14 / 2020
- Conditions
- Coronavirus Disease (COVID-19)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 18 Apr 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 16 Apr 2020 (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.
Randomized controlled interventional trial (Clinical Trial) phase 3 to assess the safety and efficacy of favipiravir versus the standard care therapy in the treatment of patients with COVID-19.
Detailed description
Study Procedures:
Screening phase:
- Obtaining an informed consent
- Written signed and dated informed consent will be obtained from each patient before being entered into the study. The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial. This will be obtained from each subject in accordance with the recommendation of the revised Declaration of Helsinki. The investigator will explain the nature, purpose and risks of the study. It will be clearly stated that the patient is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal.
- In case the patient is unable to provide his/her consent the legal guardian will give verbal approval on behaves of the patient and after he he/she will be well informed by the study design, procedure, risk and benefits over phone call.
- If it is difficult to reach the legal guardian, emergency approval will be obtained by Professional Legal Representative who will be the head authorities of the isolation hospital.
- Full medical history, concurrent medications, demographic data will be obtained.
- A thorough physical examination will be performed.
- Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and Blood oxygen saturation) will be recorded.
- Chest X-ray or CT chest will be recorded.
- Laboratory to perform the following tests:
Complete blood count with differential counts, COVID -19 PCR test by nasopharyngeal swab. C-reactive protein and serum ferritin level. Renal function tests (RFTs) (serum creatinine), Liver function tests (LFTs) (alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin), Coagulation test; prothrombin time and INR. HIV antibody, HCV antibody and HBV surface antigen (HBsAg). Urine pregnancy test for females.
Treatment phase for eligible patients:
- Eligibility confirmed
- The patient will receive information regarding the treatment duration, how to take the study treatment and the dose of the study treatment.
- The patient will receive information regarding the identification and notification of adverse events as diarrhea that occurs in about 25 % of patients and mild elevation of transaminases.
- The patient will be advised to record the daily dosing of study medications that were taken in diaries. If the patient is fatigued or uneducated the clinical pharmacist or the treating physician will be responsible for recording.
- Concomitant medications will also be recorded.
- Eligible patients in group 1 will be given favipiravir in a regimen of 3200 mg (1600 mg 12 hourly) loading dose on day-1 followed by 1200 mg maintenance dose (600 mg 12 hourly daily) on day-2 to day-10.
- Eligible patients in group 2 will receive oseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10.
- Clinical assessment will be performed on days 3 and 7 and adverse events will be recorded.
- Laboratory follow up: Days 3 and 7 of treatment
- Liver function tests (ALT and AST).
- COVID -19 PCR test by nasopharyngeal swab.
- C-reactive protein and serum ferritin levels. End point of the study: Day 14 assessment
- The patient's health status and the presence of adverse events will be assessed.
- Complete physical examination.
- Vital signs (blood pressure, heart rate and temperature) will be recorded.
- Follow-up CXR and /or CT scan.
- Liver function tests (LFTs) (alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin).
- C-reactive protein and serum ferritin level.
- COVID -19 PCR test by nasopharyngeal swab
- Post treatment period up to 30 days after end of treatment:
- Vital signs (blood pressure, heart rate and temperature) will be recorded.
- Symptoms and signs assessment will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A block-randomization scheme will be generated by computer software. 100 patients with confirmed COVID-19 will be randomized between favipiravir and the standard of care therapy (treated according to the national protocol) in a 1:1 ratio. Group 1: 50 patients will receive the investigational drug favipiravir. Group 2: 50 patients will receive oseltamivir and hydroxychloroquine as the national standard of care therapy.
| Arm | Type | Receives |
|---|---|---|
| favipiravir | Experimental | Drug: favipiravirfavipiravir in a regimen of 3200 mg (1600 mg 12 hourly) loading dose on day-1 followed by 1200 mg maintenance dose (600 mg 12 hourly daily) on day-2 to day-10 |
| Standard of care therapy | Active comparator | Drug: Standard of care therapyoseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 80 years.
- Patients with confirmed COVID-19 documented by a diagnostic laboratory test (e.g., nasopharyngeal swab) at the time of illness.
- And Have mild to moderate symptoms according to the national protocol classification of patients.
Key exclusion criteria (3 listed)
- Patients have severe or immediately life-threatening COVID-19, Severe disease is defined as: dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours Life-threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure
- Pregnant or lactating females.
- Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.
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 |
|---|---|---|
| favipiravirAlso: pyrazine carboxamide derivativepyrazine carboxamide derivative (6-fluoro-3-hydroxy-2-pyrazinecarboxamide), a new type of RNA-dependent RNA polymerase (RdRp) inhibitor | Drug | favipiravir |
| Standard of care therapyAlso: National Egyptian guidelineoseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10 | Drug | Standard of care therapy |
Primary outcome
Viral clearance
Time frame: 14 days
Two successive negative COVID-19 PCR analysis tests 48-72 hours apart
Clinical improvement
Time frame: 14 days
Normal body temperature for 48 hours
1 secondary outcome
Radiological Improvement
Time frame: 14 days
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 25 Jun 2020.
- 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.
Hany Dabbous principal investigator
Ain Shams University
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 Coronavirus Disease (COVID-19), run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 3 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 25 Jun 2020. 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 Egypt. 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?
Viral clearance (time frame: 14 days). The study lists 2 primary outcomes in all. 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 25 Jun 2020.