FAvipiravir and HydroxyChloroquine Combination Therapy

  • STATUS
    Recruiting
  • End date
    Nov 25, 2021
  • participants needed
    520
  • sponsor
    King Abdullah International Medical Research Center
Updated on 25 January 2021
SARS
oximetry
hydroxychloroquine
favipiravir

Summary

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.

Description

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.

Details
Condition COVID19
Treatment Favipiravir and Hydroxychloroquine
Clinical Study IdentifierNCT04392973
SponsorKing Abdullah International Medical Research Center
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion 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 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

Exclusion Criteria

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
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