Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
231 participants
INTERVENTIONAL
2020-07-23
2021-08-04
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Favipiravir
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)
Favipiravir
1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
Placebo
9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days).
Placebo
(9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)
Interventions
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Favipiravir
1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
Placebo
(9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)
Eligibility Criteria
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Inclusion Criteria
1. Should be at least 18 years of age
2. Male or non-pregnant female (pregnancy testing is not mandatory. If the patient requests or is not sure, the study team will provide it)
3. 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
4. Patients have to be enrolled within 5 days of disease onset.
Exclusion Criteria
1. Patients with concomitant documented bacterial pneumonia established through positive sputum cultures
2. Patients who are pregnant or breastfeeding
3. Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the patient previously for influenza)
4. 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
18 Years
100 Years
ALL
No
Sponsors
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Ministry of Health, Saudi Arabia
OTHER_GOV
King Abdullah International Medical Research Center
OTHER
Responsible Party
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Principal Investigators
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Mohammad Bosaeed
Role: PRINCIPAL_INVESTIGATOR
KAMC-RD, Ministry of National Guard Health Affairs (MNGHA), Saudi Arabia
Locations
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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
Countries
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References
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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.
Other Identifiers
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RC 20/220/R
Identifier Type: -
Identifier Source: org_study_id