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
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|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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 unable to make informed decisions).
- Moderate or Severe COVID-19, defined as oxygen saturation (Sao2) of 94% or less while they were breathing ambient air or significant clinical symptoms with Chest X ray changes that require hospital admission.
- patients had to be enrolled within 10 days of disease onset
- Patients who are pregnant or breastfeeding.
- Will be transferred to a non-study site hospital or expected to be discharged within 72 hours.
- Known sensitivity/allergy to hydroxychloroquine or Favipiravir
- Current use of hydroxychloroquine for another indication
- Prior diagnosis of retinopathy
- Prior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Major comorbidities increasing the risk of study drug including: i. Hematologic malignancy, ii. Advanced (stage 4-5) chronic kidney disease or dialysis therapy, iii. Known history of ventricular arrhythmias, iv. Current use of drugs that prolong the QT interval, Severe liver damage (Child-Pugh score ≥ C, AST> 5 times the upper limit), HIV.
- 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).
- Clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission.
- Patient with irregular rhythm
- Patient with a history of heart attack (myocardial infarction)
- Patient with a family history of sudden death from heart attack before the age of 50
- Take other drugs that can cause prolonged QT interval
- Patient who is receiving immunosuppressive therapy (cyclosporin) which cannot be switched to another agent or adjusted while using the investigational drug
- Gout/history of Gout or hyperuricemia (above the ULN), hereditary xanthinuria or xanthine calculi of the urinary tract.
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|
|Responsible Party:||King Abdullah International Medical Research Center|
|Other Study ID Numbers:||
|First Posted:||May 19, 2020 Key Record Dates|
|Last Update Posted:||August 20, 2021|
|Last Verified:||August 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action