COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04392973

Mohammad Bosaeed, MD

dr.bosaeed@live.com

2020-05-19

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

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.

2

King Abdullah International Medical Research Center

18

None

Saudi Arabia

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

268

Clinical Improvement

None

Not reported

[{"arm_notes": "", "treatment_id": 1556, "treatment_name": "Favipiravir+hydroxychloroquine", "treatment_type": "Antivirals+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]