COVID-19 trials registries data warehouse

http://en.irct.ir/trial/55549

Dr. Majid Saeedi

publicrel@mazums.ac.ir

2021-07-18

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

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

2

Mazandaran University of Medical Sciences

18

80

Iran

Severe disease at enrollment

6: Severe disease at enrollment

100

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

Phase 3

[{"arm_notes": "", "treatment_id": 423, "treatment_name": "Dulotegravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]