Evaluation of the Efficacy and safety of dolutegravir in patients with moderate COVID-19 disease

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2020
INTERVENTION: Intervention 1: In the intervention group, patients receive dulotegravir 50 mg daily for 7 days in addition to the standard treatment regimen. This study was performed on patients with definitive diagnosis of Covid‐19 by CT scan at Razi Hospital in Ghaemshahr and evaluated the efficacy and safety of Dulotegravir. It should be noted that in order to eliminate Confounding by indication as well as Confounding by severity, in addition to patients, therapists and the treating physician will be blind to the type of treatment. Intervention 2: In the control group, patients receive placebo for 7 days along with the standard treatment regimen. CONDITION: COVID‐19. ; COVID‐19, virus identified U07.1 PRIMARY OUTCOME: Recovery after 10 days from the start of the study is defined as follows: O2sat =95% or improvement compared to baseline no fever, no dyspnea, no cough or improved cough, No fatigue or improved fatigue, oral intake for at least 24 hours. Timepoint: Daily in all duration of study. Method of measurement: By designed investigator checklist. SECONDARY OUTCOME: Number of days hospitalized. 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: By a designed checklist. Survival rate. Timepoint: Daily. Method of measurement: By a designed checklist. INCLUSION CRITERIA: 1) Aged between 18 to 80 2) Patients with definitive diagnosis of covid‐19 (Lung involvement in Covid‐19 compliant CT confirmed by coronavirus pneumonia). 3) =8 days since illness onset 4) Having one of the following symptoms: Fever (= 37.8 ° C at any time), Dry cough, Shortness of breath, Fatigue 5) One of the following: Involvement of 3 or more lobes of the pulmonary lobes, >O2Sat< 94% 6) Patients with signing Informed Consent Form Willing
Epistemonikos ID: f649546d4f82b8ead9df1a72d15debbfa2b93e88
First added on: Jul 19, 2021