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IRCT20200328046886N2 IRCT 2020-10-12 Mazandaran University of Medical Sciences Evaluation of the efficacy and safety of Atazanavir/Ritonavir plus Hydroxychloroquine regimen in patients with moderate COVID-19 Comparison of the efficacy and safety of Atazanavir/Ritonavir plus Hydroxychloroquine regimen with Lopinavir/Ritonavir plus Hydroxychloroquine regimen in patients with moderate COVID-19, A randomized, double-blind study 2020-08-22 anticipated 120 Complete https://irct.ir/trial/50980 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before randomization, the effect of confounding factors on the two treatment arms was adjusted. Sealed envelope online software was used to randomize the treatment assignment to the two treatment arms A and B (Keltra/ hydroxychloroquine diet and atazanavir/ritonavir/ hydroxychloroquine diet, respectively) and thus 120 patients were divided into 30 quadri blocks, Blinding description: To eliminate Confounding by indication as well as Confounding by severity, the investigator (clinical pharmacy assistant) and patients will be blind to the type of treatment. The treatment will be assigned in accordance with the above block randomization under the supervision of a physician. 3 Effectiveness and safety of Atazanavir in COVID-19. 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 administered. Atazanavir Considerations: If the patient is receiving PPIs, an interval of at least 12 hours after PPIs and at least 2 hours after H2 blocker should be considered. Take the medicine after or with a meal. Drug interactions with atazanavir including the concomitant use of statins, CYP3A4 inducers, or inhibitors should be considered to dose adjustment. Intervention 2: Intervention group: Hydroxychloroquine 400 mg single dose on the first day with Kaletra (Lopinavir/Ritonavir) (50/200) 2 tablets every 12 hours for at least 5 days is administered. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: Starting 1 month after publication To whom: Researchers working in academic and scientific institutions Conditions: In situations which the researchers have expressed their willing Where to obtain: Email address How to obtain: In a short time after request, will be available with email Comments:
public Hamideh Abbaspour Kasgari
Faculty of pharmacy, Payambar Azam academic complex, 18 km of Khazar Abad Ave, Sari
Sari Iran (Islamic Republic of) 4763947444 +98 11 4203 1035 dr.abbaspour1@yahoo.com Mazandaran University of Medical Sciences scientific Hamideh Abbaspour Kasgari
Faculty of pharmacy, Payambar Azam academic complex, 18 km of Khazar Abad Ave, Sari
Sari Iran (Islamic Republic of) 4763947444 +98 11 4203 1035 dr.abbaspour1@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 75 years Both 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 U07.1 COVI Virus Identified Treatment - Drugs Treatment - Drugs 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 administered. Atazanavir Considerations: If the patient is receiving PPIs, an interval of at least 12 hours after PPIs and at least 2 hours after H2 blocker should be considered. Take the medicine after or with a meal. Drug interactions with atazanavir including the concomitant use of statins, CYP3A4 inducers, or inhibitors should be considered to dose adjustment. Intervention group: Hydroxychloroquine 400 mg single dose on the first day with Kaletra (Lopinavir/Ritonavir) (50/200) 2 tablets every 12 hours for at least 5 days is administered. 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). 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. Mazandaran University of Medical Sciences Approved 2020-08-12 Research Ethics Committee of Mazandaran University of Medical Sciences Imam Square, Joybar Three Ways, the beginning of Valiasr Highway, the headquarters of Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)