COVID-19Phase 2/3Avi-MildNCT04464408
Favipiravir Therapy in Adults With Mild COVID-19
A Phase 2/3 study testing Favipiravir in people with COVID-19, run by King Abdullah International Medical Research Center at 7 sites in Saudi Arabia.
Trial summary
Favipiravir is a selective and potent inhibitor of influenza viral RNA polymerase. It acts as a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially novel coronavirus (2019-nCoV). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Favipiravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 7 sitesSaudi Arabia
- Study dates
- 23 Jul 2020to 4 Aug 2021
- Phase
- Phase 2/3
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be eligible according to the following criteria for enrollment
- Should be at least 18 years of age
- Male or non-pregnant female (pregnancy testing is not mandatory. If the patient requests or is not sure, the study team will provide it)
- Diagnosed with mild COVID-19* confirmed by positive PCR test for SARS-CoV-2 at the time of recruitment, a result within the last five days
- Patients have to be enrolled within 5 days of disease onset.
Who cannot join
- Patients meeting any of the following criteria will be excluded from trial enrolment:
- Patients with concomitant documented bacterial pneumonia established through positive sputum cultures
- Patients who are pregnant or breastfeeding
- Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the patient previously for influenza)
- Major comorbidities increasing the risk of study drug including
- Hematologic malignancy
Show all 12Show fewer
- Advanced (stage 4-5) chronic kidney disease or dialysis therapy
- Severe liver damage (Child-Pugh score C, AST> 5 times the upper limit)
- HIV
- Gout/history of Gout or hyperuricemia (two times above the ULN)
- Having used Favipiravir or participated in any other interventional drug clinical study within 30 days before the first dose of study drug (i.e., the patient received it for influenza previously) (7) The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues) (8) Clinical prognostic non-survival, palliative care, or in a deep coma and have no response to supportive treatment within three hours of admission.
- Hospitalized patients for mild, moderate, or severe COVID-19
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Saudi Arabia7 sites
King Fahad Hospital - Madinah
Al Madīnah
Primary Health Care-Safiyah
Al Madīnah
Prince Mohammed Bin Abdul Aziz Hospital - Al Madinah
Al Madīnah
King Abdullah Medical City - Makkah
Mecca
King Abdulaziz Medical City - Riyadh
Riyadh
Primary Health Care-Al Mansoura
Riyadh
Primary Health Care-Al Urijah
Riyadh
About this study
Official title: A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19
Favipiravir is a selective and potent inhibitor of influenza viral RNA polymerase. It acts as a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially novel coronavirus (2019-nCoV). The purpose of this study is to evaluate the clinical efficacy and safety of Favipiravir in comparison to placebo in the treatment of mild COVID-19 cases. It is a Multicenter, randomized double-blinded, parallel-group trial.
- Conditions
- COVID-19
- Being tested
- Favipiravir, Placebo
- Keywords
- Favipiravir, COVID19, Mild illness, Saudi Arabia
- 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
1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
PlaceboDrug
(9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir | Experimental | Favipiravir: 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (Maximum days of therapy is 7 days) Receives: Drug: Favipiravir |
| Placebo | Placebo comparator | 9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR negative
Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization
Measured: 15 days
Secondary outcomes (5)
Time from randomization to clinical recovery
The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory symptoms, and relief of cough (or other relevant symptoms at enrollment) that is maintained for at least 72 hours.
Measured: 15 days
Evaluate symptoms progression
Evaluate symptoms severity and the disease course progression in both arms till 28 days after starting the medicine.
Measured: 28 days
Evaluate Faviparivirs effect
To evaluate Favipiravir's effect on the requirement of the use of antipyretics, analgesics, or antibiotics within 15 days after starting medicine.
Measured: 15 days
Evaluate Favipiravir's effect
To evaluate Favipiravir's effect on disease complications within 28 days after starting medicine (hospitalization, ICU admission, or Mechanical ventilation )
Measured: 28 days
Evaluate the safety of Favipiravir
Evaluate the safety of investigational drug compared to the control arm within 15 days after starting the medicine. This is assessed by allergic reactions, medication intolerance, liver toxicity, and hyperuricemia in subjects
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start23 Jul 2020
- Primary completion4 Aug 2021
- Study completion4 Aug 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 COVID-19Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Saudi Arabia
- Responsible party
- Sponsor
- Investigators
- Mohammad Bosaeed, Principal investigator, KAMC-RD, Ministry of National Guard Health Affairs (MNGHA), Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464408
- Sponsor's protocol ID
- RC 20/220/R
- Acronym
- Avi-Mild
- Status last verified
- Nov 2021
- First submitted
- 28 Jun 2020
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bosaeed M, Alharbi A, Hussein M, Abalkhail M, Sultana K, Musattat A, Alqahtani H, Alshamrani M, Mahmoud E, Alothman A, Alsaedy A, Aldibasi O, Alhagan K, Asiri AM, AlJohani S, Al-Jeraisy M, Alaskar A. Multicentre randomised double-blinded placebo-controlled trial of favipiravir in adults with mild COVID-19. BMJ Open. 2021 Apr 14;11(4):e047495. doi: 10.1136/bmjopen-2020-047495.
PubMed 33853806
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19
- ClinicalTrials.gov ID
- NCT04464408
- Acronym / sponsor ID
- Avi-Mild / RC 20/220/R
- Conditions
- COVID-19
- Keywords
- Favipiravir, COVID19, Mild illness, Saudi Arabia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Collaborators
- Ministry of Health, Saudi Arabia
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 9 Jul 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.
Favipiravir is a selective and potent inhibitor of influenza viral RNA polymerase. It acts as a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially novel coronavirus (2019-nCoV). The purpose of this study is to evaluate the clinical efficacy and safety of Favipiravir in comparison to placebo in the treatment of mild COVID-19 cases. It is a Multicenter, randomized double-blinded, parallel-group trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Favipiravir | Experimental | Drug: FavipiravirFavipiravir: 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (Maximum days of therapy is 7 days) |
| Placebo | Placebo comparator | Drug: Placebo9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be eligible according to the following criteria for enrollment
- Should be at least 18 years of age
- Male or non-pregnant female (pregnancy testing is not mandatory. If the patient requests or is not sure, the study team will provide it)
- Diagnosed with mild COVID-19* confirmed by positive PCR test for SARS-CoV-2 at the time of recruitment, a result within the last five days
- Patients have to be enrolled within 5 days of disease onset.
Key exclusion criteria (12 listed)
- Patients with concomitant documented bacterial pneumonia established through positive sputum cultures
- Patients who are pregnant or breastfeeding
- Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the patient previously for influenza)
- Major comorbidities increasing the risk of study drug including
- Having used Favipiravir or participated in any other interventional drug clinical study within 30 days before the first dose of study drug (i.e., the patient received it for influenza previously) (7) The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues) (8) Clinical prognostic non-survival, palliative care, or in a deep coma and have no response to supportive treatment within three hours of admission.
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 |
|---|---|---|
| Favipiravir1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily | Drug | Favipiravir |
| Placebo(9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days) | Drug | Placebo |
Primary outcome
PCR negative
Time frame: 15 days
Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization
5 secondary outcomes
Time from randomization to clinical recovery
Time frame: 15 days
Evaluate symptoms progression
Time frame: 28 days
Evaluate Faviparivirs effect
Time frame: 15 days
Evaluate Favipiravir's effect
Time frame: 28 days
Evaluate the safety of Favipiravir
Time frame: 28 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 5 Nov 2021.
- Derived from this study: PubMed 33853806Bosaeed M, Alharbi A, Hussein M, Abalkhail M, Sultana K, Musattat A, Alqahtani H, Alshamrani M, Mahmoud E, Alothman A, Alsaedy A, Aldibasi O, Alhagan K, Asiri AM, AlJohani S, Al-Jeraisy M, Alaskar A. Multicentre randomised double-blinded placebo-controlled trial of favipiravir in adults with mild COVID-19. BMJ Open. 2021 Apr 14;11(4):e047495. doi: 10.1136/bmjopen-2020-047495.
- 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.
Mohammad Bosaeed principal investigator
KAMC-RD, Ministry of National Guard Health Affairs (MNGHA), Saudi Arabia
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Favipiravir in people with COVID-19, run by King Abdullah International Medical Research Center at 7 sites in Saudi Arabia.
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 12 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 5 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 7 sites in Saudi Arabia. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
PCR negative (time frame: 15 days). 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 NCT04464408, 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 5 Nov 2021.