Effectiveness and safety of Atazanavir in COVID-19. Virus Identified
Conditions
Interventions
Intervention 1: Intervention group: Hydroxychloroquine 400 mg single dose on the first day with atazanavir/ritonavir 100/300 mg daily (2 serving which one contains placebo) for at least 5 days is admi
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery within 10 days of starting medication. Timepoint: daily during 10 days from the beginning of intervention. Method of measurement: Measurement of O2 saturation% by pulse oximeter and clinical signs under the supervision of the physician including (no fever - no dyspnea - no cough or improvement compared to baseline - no fatigue or improvement compared to baseline - oral intake for at least 24 hours). | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival rate. Timepoint: daily. Method of measurement: By a designed checklist.;Recovery within 14 days after starting medication. Timepoint: daily until the day 14 after beginning of intervention. Method of measurement: Measurement of O2 saturation% by pulse oximeter and clinical signs under the supervision of the physician including (no fever - no dyspnea - no cough or improvement compared to baseline - no fatigue or improvement compared to baseline - oral intake for at least 24 hours).;Number of days hospitalized. Timepoint: daily. Method of measurement: By a designed checklist.;Number of days in ICU. Timepoint: daily. Method of measurement: By a designed checklist.;Number of days intubated. Timepoint: daily. Method of measurement: By a designed checklist. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamideh Abbaspour Kasgari
Mazandaran University of Medical Sciences
Outcome results
None listed