Status:
COMPLETED
FAvipiravir and HydroxyChloroquine Combination Therapy
Lead Sponsor:
King Abdullah International Medical Research Center
Conditions:
COVID19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 stand...
Detailed 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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2021
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT04392973
Start Date
May 21 2020
End Date
April 26 2021
Last Update
August 20 2021
Active Locations (8)
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1
King Abdulaziz Hospital - Al Ahsa
Hasa, Eastern Province, Saudi Arabia
2
AlMadina General Hospital
Al Madīnah, Saudi Arabia
3
Al-Qatif Central Hospital
Al Qaţīf, Saudi Arabia
4
Imam Abdulrahman Al Faisal Hospital - Dammam
Dammam, Saudi Arabia