This study is a randomized, open-label, parallel groups multi-centered trial were participants are assigned to either an intervention arm ( a combination of Favipiravir and Hydroxychloroquin) or standard of care.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
268
Route of Administration: Oral (or through Nasogastric tube) Dose: 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.
King Abdulaziz Hospital - Al Ahsa
Hasa, Eastern Province, Saudi Arabia
AlMadina General Hospital
Al Madīnah, Saudi Arabia
Al-Qatif Central Hospital
Al Qaţīf, Saudi Arabia
Imam Abdulrahman Al Faisal Hospital - Dammam
Dammam, Saudi Arabia
Clinical Improvement
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.
Time frame: 28 days
Viral shedding
PCR test negative conversion days from positive to negative.
Time frame: 28 days
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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
Imam Abdulrahman Alfaisal Hospital
Riyadh, Saudi Arabia