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

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2020
INTERVENTION: 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. CONDITION: Effectiveness and safety of Atazanavir in COVID‐19. ; Virus Identified U07.1 COVI PRIMARY OUTCOME: 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: 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. 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). Survival rate. Timepoint: daily. Method of measurement: By a designed checklist. 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
Epistemonikos ID: 6fb8b4bafb0d9142e0e761188932d33dfaaa5695
First added on: Oct 13, 2020