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

Phase 3

Recruiting

Conditions: COVID-19.
COVID-19, virus identified
U07.1

Registration Number: IRCT20200328046886N3

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

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

Exclusion Criteria

1) Severe hepatic impairment (Child-pough C)
2) Patients taking Phenytoin, Fosphenytoin, Oxcarbazepine, Phenobarbital, Primidone and St John's Wort
3) History of disease because of COVID-19
4) History of taking Covid-19 experimental drug
5) lactation
6) Requires intubation at admission
7) Sensitivity to Dolutegravir
8) Severe disability that prevents cooperation
9) Patient dissatisfaction with the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.;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.