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IRCT20200328046886N3 IRCT 2021-07-18 Mazandaran University of Medical Sciences 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) 2021-08-22 anticipated 100 Complete https://irct.ir/trial/55549 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 COVID-19. 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. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: after complete of the study To whom: data only available for people working in academic institutions Conditions: any change of the data avoided Where to obtain: the preferred way of communication is email address How to obtain: in few time after send email the data could be available Comments:
public Hamideh Abbaspour Kasgari
Faculty of pharmacy, Payambar Azam academic complex, 18 km of Khazar Abad Ave, Sari
Sari Iran (Islamic Republic of) 4763947444 +98 11 4203 1035 dr.abbaspour1@yahoo.com Mazandaran University of Medical Sciences scientific Hamideh Abbaspour Kasgari
Faculty of pharmacy, Payambar Azam academic complex, 18 km of Khazar Abad Ave, Sari
Sari Iran (Islamic Republic of) 4763947444 +98 11 4203 1035 dr.abbaspour1@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 80 years Both 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 U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs 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. In the control group, patients receive placebo for 7 days along with the standard treatment regimen. 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. 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. Mazandaran University of Medical Sciences Approved 2021-02-24 Research Ethics Committee of Mazandaran University of Medical Sciences Imam Square, Joybar Three Ways, the beginning of Valiasr Highway, the headquarters of Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)