FAvipiravir and HydroxyChloroquine Combination Therapy (FACCT)
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|ClinicalTrials.gov Identifier: NCT04392973|
Recruitment Status : Completed
First Posted : May 19, 2020
Last Update Posted : August 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID19||Combination Product: Favipiravir and Hydroxychloroquine||Not Applicable|
In this trial, the investigators want to evaluate the efficacy of the combination of Favipiravir and Hydroxychloroquine as potential therapy for moderate and severe cases with COVID -19. Favipiravir which is a new type of RNA-dependent RNA polymerase (RdRp) inhibitor has activity against influenza virus, and Hydroxychloroquine, an analogue of chloroquine, has a clinical safety profile better than that of chloroquine and allows higher daily dose, Chloroquine is a widely used antimalarial that was found to be a potential broad-spectrum antiviral.
There is an urgent need to explore therapeutic options for SARS-CoV-2 in order to face the pandemic. The selected combination was based on limited evidence clinically and in vitro on the efficacy of the Favipiravir and Hydroxychloroquine in SARS-CoV-2. The two medications were listed in many guidelines as treatment options and ongoing trials assessing their efficacy and safety. Thus, the investigators want to prove the effectiveness of the combination as therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||268 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, open-label, parallel groups were participants are assigned to either an intervention arm or standard of care.|
|Masking:||None (Open Label)|
|Official Title:||A Trial of Favipiravir and Hydroxychloroquine Combination in Adults Hospitalized With Moderate and Severe Covid-19|
|Actual Study Start Date :||May 21, 2020|
|Actual Primary Completion Date :||January 26, 2021|
|Actual Study Completion Date :||April 26, 2021|
Combination therapy Favipiravir (10 days) + Hydroxychloroquine(5 days)
Combination Product: Favipiravir and Hydroxychloroquine
Route of Administration: Oral (or through Nasogastric tube)
Favipiravir: Administer 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (total days of therapy is 10 days or till hospital discharge)
Hydroxychloroquine (400mg) twice daily on day 1; for days 2-5 (200mg) twice daily.
Other Name: Avigan
No Intervention: Control
Standard of Care Treatment for COVID-19 Infection
- Clinical Improvement [ Time Frame: 28 days ]The primary endpoint is the time to clinical improvement, defined as the time from the randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first.
- Viral shedding [ Time Frame: 28 days ]PCR test negative conversion days from positive to negative.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392973
|King Abdulaziz Hospital - Al Ahsa|
|Hasa, Eastern Region, Saudi Arabia|
|AlMadina General Hospital|
|Al Madīnah, Saudi Arabia|
|Al-Qatif Central Hospital|
|Al-Qatif, Saudi Arabia|
|Imam Abdulrahman Al Faisal Hospital - Dammam|
|Dammam, Saudi Arabia|
|King Abdulaziz Medical City|
|Jeddah, Saudi Arabia|
|King Abdulaziz Hospital - Makkah|
|Mecca, Saudi Arabia|
|King Abdulaziz Medical City, National Guard Health Affairs|
|Riyadh, Saudi Arabia, 11426|
|Imam Abdulrahman Alfaisal Hospital|
|Riyadh, Saudi Arabia|
|Study Director:||Ahmad Alaskar||KAIMRC|