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

The aim of this study was to evaluate the effectiveness of Dolatgravir diet and compare it with the standard diet used.

This study is a randomized, double-blind, placebo-controlled clinical trial. In order to eliminate Confounding by indication and Confounding by severity, patient and therapists will be blind to the type of treatment.

Patients are divided into two groups of 50. In one group, the drug will be given at a dose of 50 mg for 7 days and the placebo will be administered with standard treatments in the other group. Patients and care provider are blinded.

Inclusion: Aged between 18 to 80, Definitive diagnosis of covid-19, ≤8 days since illness onset, Having fever (≥ 37.8 ° C at any time), dry cough, shortness of breath or fatigue Involvement of 3 or more lobes of the pulmonary lobes or >O2Sat< 94% , Written consent of patients Exclusion: Severe hepatic impairment, Patients taking Phenytoin, Fosphenytoin, Oxcarbazepine, Phenobarbital, Primidone and St John's Wort, History of disease because of COVID-19, History of taking Covid-19 experimental drug, lactation, Requires intubation at admission, Sensitivity to Dolutegravir, Severe disability and Patient dissatisfaction with the study

Receive dulotegravir at a dose of 50 mg daily for 7 days + standard treatment regimen in the intervention group Receive placebo daily for 7 days + standard treatment regimen in the control group

Clinical recovery after 14 days from the start of treatment, No need for intensive care and mechanical ventilation, Decrease the hospital admission time, Decrease the time to need nasal oxygen , Eradication of the virus from the nose and throat in RT-PCR test

This study is a parallel randomized double-blind clinical trial. To randomize the treatment assignment to the two treatment arms A and B (standard protocol regimen and recommended regimen, respectively) from Restricted randomization schemes by Blocking method and online software Sealed envelope (https://www.sealedenvelope.com/simple-randomiser/ v1 / lists) was used and thus 100 patients will be placed in 25 blocks of 4.

It should be noted that in order to eliminate Confounding by indication as well as Confounding by severity, therapist clinicians and patients will be blind (Double masking) regarding the type of treatment (Treatment assignment). Assignment of treatment in accordance with the above blocking will be done under the supervision of a clinical pharmacist and by sending Sealed envelope. On the other hand, the final evaluator and analyst of the study are aware of how the treatment is allocated.

all collected deidentified IPD

after complete of the study

data only available for people working in academic institutions

any change of the data avoided

the preferred way of communication is email address

in few time after send email the data could be available