FAvipiravir and HydroxyChloroquine Combination Therapy

Not Applicable

Completed

• Conditions: COVID19
• Interventions: Combination Product: Favipiravir and Hydroxychloroquine

• Registration Number: NCT04392973
• Lead Sponsor: King Abdullah International Medical Research Center

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 standard of care.

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 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 Timeline

• Study First Submitted: 2020-05-10
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-19
• Study Start: 2020-05-21
• Primary Completion: 2021-01-26
• Study Completion: 2021-04-26
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

1. Should be at least 18 years of age
2. Male or nonpregnant female,
3. Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection.
4. 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).
5. 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.
6. patients had to be enrolled within 10 days of disease onset

Exclusion Criteria

1. Patients who are pregnant or breastfeeding.
2. Will be transferred to a non-study site hospital or expected to be discharged within 72 hours.
3. Known sensitivity/allergy to hydroxychloroquine or Favipiravir
4. Current use of hydroxychloroquine for another indication
5. Prior diagnosis of retinopathy
6. Prior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
7. 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.
8. 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).
9. Clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission.
10. Patient with irregular rhythm
11. Patient with a history of heart attack (myocardial infarction)
12. Patient with a family history of sudden death from heart attack before the age of 50
13. Take other drugs that can cause prolonged QT interval
14. Patient who is receiving immunosuppressive therapy (cyclosporin) which cannot be switched to another agent or adjusted while using the investigational drug
15. Gout/history of Gout or hyperuricemia (above the ULN), hereditary xanthinuria or xanthine calculi of the urinary tract.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Favipiravir and Hydroxychloroquine	Combination therapy Favipiravir (10 days) + Hydroxychloroquine(5 days)

Primary Outcome Measures

Name	Time	Method
Clinical Improvement	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.

Secondary Outcome Measures

Name	Time	Method
Viral shedding	28 days	PCR test negative conversion days from positive to negative.

Trial Locations

Locations (8)

King Abdulaziz Hospital - Al Ahsa; 🇸🇦 Hasa, Eastern Region, Saudi Arabia

Imam Abdulrahman Al Faisal Hospital - Dammam; 🇸🇦 Dammam, Saudi Arabia

AlMadina General Hospital; 🇸🇦 Al Madīnah, Saudi Arabia

King Abdulaziz Medical City; 🇸🇦 Jeddah, Saudi Arabia

King Abdulaziz Medical City, National Guard Health Affairs; 🇸🇦 Riyadh, Saudi Arabia

King Abdulaziz Hospital - Makkah; 🇸🇦 Mecca, Saudi Arabia

Al-Qatif Central Hospital; 🇸🇦 Al-Qatif, Saudi Arabia

Imam Abdulrahman Alfaisal Hospital; 🇸🇦 Riyadh, Saudi Arabia