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.
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.
Combination Product: Favipiravir and Hydroxychloroquine
Route of Administration: Oral (or through Nasogastric tube)
Dose:
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
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.
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
Imam Abdulrahman Alfaisal Hospital
Riyadh, Saudi Arabia
Ahmad Alaskar, Study Director
KAIMRC