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IRCT20150914024017N1 IRCT 2020-04-03 Tehran University of Medical Sciences ReciGen for treatment of Covid-19 the efficacy of Interferon beta 1 a (ReciGen) in treatment of patients with Covid-19 in Sina Hospital Emergency Department 2020-03-27 anticipated 40 Complete https://irct.ir/trial/46665 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: a random sequence was generated by "random.org" , in which every subject in the study from number 1 to 40, is randomly assigned to one of the treatment groups A or B. based on this random sequence, patient 1 and 2 will be assigned to group A and patient number 3 will be assigned to other group and this goes on until 40 patients enroll in the study, Blinding description: the hospital pharmacist puts Recigen and Placebo (which produced by the same company and is exactly similar to Recigen without the active ingredient) in Groups A and B. he is the only person who knows which group has Recigen and which one has the placebo. the researcher injects the drug to the patients based on the randomization chart in which each patient is assigned to groups A and B. The patient, the researcher, the clinicians who supervise the patient treatment and the statistician who analyses the data will not know which group received placebo and which one received Recigen. 3 Covid 19. Intervention 1: Intervention group: subcutaneous injection of Recigen (44mcg) daily until 5 days or the discharge day (which ever come sooner) in addition to standard treatment (based on the Ministry of Health protocol: chloroquine, etc .. ). Intervention 2: Control group: subcutaneous injection of placebo daily until 5 days or the discharge day (which ever come sooner) in addition to standard treatment (based on the Ministry of Health protocol: chloroquine, etc .. ). Yes - There is a plan to make this available What will be shared: All data, protocols and reports will publish in reputable journals after statisticalanalysis When: Oct2020- April 2021 To whom: no limitation Conditions: to find a solution and treat patient who infected with new corona virus. Where to obtain: corresponding author How to obtain: all data would be public and if any questions raised, it is possible to ask from corresponding author Comments:
public Pooya Payandemehr
Imam Khomeini Ave., Hasan Abad Sq., Sina Hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1413 p-payandemehr@sina.tums.ac.ir Tehran University of Medical Sciences scientific Pooya Payandemehr
Imam Khomeini Ave., Hasan Abad Sq., Sina Hospital
Tehran Iran (Islamic Republic of) 1136746911 0098 21 6312413 p-payandemehr@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) patients who are diagnosed to have covid-19 based on Chest Ct Scan patients being admitted to emergency room based on local guidelines age 18 years or loder 18 years no limit Both pregnancy breast feeding do not consent to be in this study allergies to interferon not having a proper phone number for follow up calls U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: subcutaneous injection of Recigen (44mcg) daily until 5 days or the discharge day (which ever come sooner) in addition to standard treatment (based on the Ministry of Health protocol: chloroquine, etc .. ) Control group: subcutaneous injection of placebo daily until 5 days or the discharge day (which ever come sooner) in addition to standard treatment (based on the Ministry of Health protocol: chloroquine, etc .. ) Hospital stay. Timepoint: discharge date. Method of measurement: checklist. Need for ICU admission. Timepoint: discharge date. Method of measurement: check list based on treating clinicians judgment. Need for intubation. Timepoint: discharge date. Method of measurement: check list based on treating clinicians judgment. O2 saturation. Timepoint: daily. Method of measurement: pulse oxymeter. Fever. Timepoint: daily. Method of measurement: thermometer. Side effects. Timepoint: daily. Method of measurement: check list based on treating clinicians judgment. Tehran University of Medical Sciences Approved 2020-03-23 ethics committee, Vice-Chancellor in Research Affairs- Tehran University of Medical Sciences Imam Khomeini ave, Hasan abad sq, Sina Hospital Tehran Tehran Iran (Islamic Republic of)