COVID-19 trials registries data warehouse

http://en.irct.ir/trial/50980

Research and technology department

publicrel@mazums.ac.ir

2020-10-12

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Getting out the informed consent form from all of the patients or their guardian Aged between 18 to 75 Having one of the following symptoms: Dry cough, Severe weakness or fatigue, Dyspnea, Feeling of pain and pressure on the chest, With or without fever greater than 38° C Days from onset of the symptoms equal or less than 7 Definitive diagnosis of moderate COVID-19 based on involvement of up to 3 or 4 pulmonary lobes with an area less than one-third the volume of each lobe or involvement of one or two lobes with a larger area on CT scan O2Sat<94% It is necessary to have all items 1 to 4 and at least one of items 5 and 6

History of hospitalization because of COVID-19 Participate in any other clinical trial for the treatment of COVID-19 Patients under mechanical ventilation at the baseline Bradycardia Sensitivity to Atazanavir Active cancer Immune deficiency or immune compromised Baseline abnormal ECG Pregnancy and lactation Renal impairment (CLcr<50 mL/min) Severe hepatic impairment (Child-pough C) Multi organ failure Concomitant use of rifampin, carbamazepine, phenytoin

2

Mazandaran University of Medical Sciences

18

75

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

120

Recovery within 10 days of starting medication

Phase 3

[{"arm_notes": "", "treatment_id": 1562, "treatment_name": "Hydroxychloroquine+lopinavir+ritonavir", "treatment_type": "Antimalarials+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1533, "treatment_name": "Atazanavir+hydroxychloroquine+ritonavir", "treatment_type": "Antivirals+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}]