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

Evaluation of the Efficacy and safety of dolutegravir in patients with moderate COVID-19 disease (randomized double blind placebo controlled trial)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200328046886N3
Enrollment
100
Registered
2021-07-18
Start date
2021-08-22
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. COVID-19, virus identified

Interventions

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 diag

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamideh Abbaspour Kasgari

Mazandaran University of Medical Sciences

dr.abbaspour1@yahoo.com+98 11 4203 1035

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026