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| Name | Class |
|---|---|
| Ministry of Health, Saudi Arabia | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Favipiravir | Drug | 1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| PCR negative | Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 days |
| Evaluate symptoms progression |
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Inclusion Criteria
Patients must be eligible according to the following criteria for enrollment
Exclusion criteria
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
(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
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Bosaeed | KAMC-RD, Ministry of National Guard Health Affairs (MNGHA), Saudi Arabia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Fahad Hospital - Madinah | Al Madīnah | Saudi Arabia | ||||
| Primary Health Care-Safiyah |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33853806 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C462182 | favipiravir |
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| Placebo | Drug | (9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days) |
|
Evaluate symptoms severity and the disease course progression in both arms till 28 days after starting the medicine. |
| 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. | 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 ) | 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 | 28 days |
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |