Evaluation of the efficacy and safety of Atazanavir/Ritonavir plus Hydroxychloroquine regimen in patients with moderate COVID-19

Phase 3

Recruiting

• Conditions: Effectiveness and safety of Atazanavir in COVID-19.; Virus Identified; U07.1 COVI

• Registration Number: IRCT20200328046886N2
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.