Favipiravir Therapy in Adults With Mild COVID-19
Avi-Mild
A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19
1 other identifier
interventional
231
1 country
7
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Jul 2020
Typical duration for phase_2 covid19
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2020
CompletedFirst Posted
Study publicly available on registry
July 9, 2020
CompletedStudy Start
First participant enrolled
July 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2021
CompletedNovember 5, 2021
November 1, 2021
1 year
June 28, 2020
November 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PCR negative
Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization
15 days
Secondary Outcomes (5)
Time from randomization to clinical recovery
15 days
Evaluate symptoms progression
28 days
Evaluate Faviparivirs effect
15 days
Evaluate Favipiravir's effect
28 days
Evaluate the safety of Favipiravir
28 days
Study Arms (2)
Favipiravir
EXPERIMENTALFavipiravir: 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 COMPARATOR9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days).
Interventions
1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
(9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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)
- (6) 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.
- (9) Hospitalized patients for mild, moderate, or severe COVID-19
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
King Fahad Hospital - Madinah
Al Madīnah, Saudi Arabia
Primary Health Care-Safiyah
Al Madīnah, Saudi Arabia
Prince Mohammed Bin Abdul Aziz Hospital - Al Madinah
Al Madīnah, Saudi Arabia
King Abdullah Medical City - Makkah
Mecca, Saudi Arabia
King Abdulaziz Medical City - Riyadh
Riyadh, Saudi Arabia
Primary Health Care-Al Mansoura
Riyadh, Saudi Arabia
Primary Health Care-Al Urijah
Riyadh, Saudi Arabia
Related Publications (1)
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.
PMID: 33853806DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohammad Bosaeed
KAMC-RD, Ministry of National Guard Health Affairs (MNGHA), Saudi Arabia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2020
First Posted
July 9, 2020
Study Start
July 23, 2020
Primary Completion
August 4, 2021
Study Completion
August 4, 2021
Last Updated
November 5, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share