A Trial of Favipiravir and Hydroxychloroquine combination in Adults Hospitalized with moderate and severe Covid-19: A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesThe 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, we want to prove the clinical effectiveness of the combination as therapy.Trial designThis is an Open label, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. It is a multicenter trial that will compare Favipiravir plus Hydroxychloroquine combination (experimental arm) to a control arm.ParticipantsAll study procedures will be conducted in eight centres in Saudia Arabia:King Abdulaziz Medical City National Guard Health Affairs in Riyadh.King Abdulaziz Hospital - Al Ahsa, Saudi ArabiaAlMadina General Hospital, Madnia, Saudi ArabiaAl-Qatif Central Hospital, Saudi ArabiaImam Abdulrahman Al Faisal Hospital, Dammam, Saudi ArabiaKing Abdulaziz Medical City, Jeddah, Saudi ArabiaKing Abdulaziz Hospital, Makkah, Saudi ArabiaImam Abdulrahman Alfaisal Hospital, Riyadh, Saudi ArabiaInclusion Criteria• Should be at least 18 years of age,• Male or nonpregnant female,• Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection.• Able to sign the consent form and agree to clinical samples collection (or their legal surrogates if subjects are or become unab...
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