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IRCT20200317046797N2 IRCT 2020-04-03 Tabriz University of Medical Sciences Effect of Fingolimod for treatment of COVID-19-induced cytokine storm FingoCov Effect of Fingolimod for treatment of COVID-19-induced cytokine storm 2020-04-08 anticipated 40 Complete https://irct.ir/trial/46786 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Simple randomization will be generated with a computer from 1 to 40. The computer will divide the digits between the two groups. According to the sequences of admission, they will go to the control or the fingolimod group regarding the computerized random list. 3 Condition 1: Coronavirus (COVID-19)-induced pneumonia. Condition 2: Coronavirus (COVID-19)-induced pneumonia. Intervention 1: Intervention group: Twenty patients with Coronavirus (COVID-19)-induced pneumonia addition to standard regimen of covid-19، will receive Fingolimod for 1 day (50 mg one time). Intervention 2: Control group: standard regimen of covid-19 patients. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Considering the crisis conditions of the Pandemic Corona and the increasing number of patients, our top priorities are the patients' management and the search for effective medication (s).
public Dr Khalil Ansarin
Immamreza Hospital-Golgasht Street
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 2898 dr.ansarin@gmail.com Tabriz University of Medical Sciences scientific Mohammadreza Ardalan
Golgasht street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 9331 Ardalan34@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Moderate to severe 2019-nCoV-infected 18 Years to 80 Years Patients or authorized family members volunteered to participate in this study and signed informed consent Both genders 18 years 80 years Both Patient with elevated liver enzymes (3 times) Patients who are participating in other drug clinical trials Patients with active pulmonary tuberculosis Patients with definite bacterial and fungal infections Pregnant or lactating women Patient with active thrombotic event U07.1 J12.8 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Twenty patients with Coronavirus (COVID-19)-induced pneumonia addition to standard regimen of covid-19، will receive Fingolimod for 1 day (50 mg one time). Control group: standard regimen of covid-19 patients Improvement of the symptoms of lung, pulmonary infiltrates. Timepoint: At baseline (before intervention) and 2 day after drug administration. Method of measurement: Lung CT scan. Decreased hospitalization period. Timepoint: At baseline and discharge time. Method of measurement: counting the hospitalization days. Mortality rate. Timepoint: At baseline and discharge time. Method of measurement: observation. Need for intubation. Timepoint: period of hospitalization. Method of measurement: observation or reading of hospitalized documents. Tabriz University of Medical Sciences Approved 2020-03-24 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)