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IRCT20200511047396N1 IRCT 2020-05-16 CinnaGen company Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in hospitalized Covid-19 patients Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in hospitalized Covid-19 patients 2020-06-30 anticipated 50 Complete https://irct.ir/trial/48048 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization (block sizes of 4) will be used to allocate drug or placebo to the patients of the study. Test drug or placebo will have randomization code which is specific for each patient and was generated by the randomization process. Randomization will not be exposed to the trial executers and will be provided to the investigator in non-transparent sealed envelopes, Blinding description: Test drug and placebo are totally similar and have same color, shape, and size and is not distinguishable by patients or investigators. 3 COVID-19. Intervention 1: Intervention group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine etc,..), patients will receive 1 puff (equall to 1000 IU of interferon beta 1a)of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days. Intervention 2: Control group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine etc,..), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days. 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 It is not yet known if there will be a plan to make this available
public Ashraf Karbasi
Baqiyatallah University of Medical Sciences
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8126 2040 ashraf.karbasi@yahoo.com Bagheiat-allah University of Medical Sciences scientific Ashraf Karbasi
Baqiyatallal Hospital
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8126 2040 ashraf.karbasi@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients who have Covid-19 based on the CT-scan or RT-PCR findings Hospitalized patients Willingness to participate in the study for trial period and signing the informed consent form Age between 20-65 20 years 65 years Both Pregnancy Breastfeeding Use of ARB/ACEi History of hypotension have no consent to participate in the study Allergic sensitivity to the interferon products Not availability of phone number or it is possible to be transferred to other hospitals Having the CKD or patients who need dialysis at the begining of the study Having any disease or condition that based on the physician judgment cannot participate in the study Participation in any other trials of Covid-19 U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine etc,..), patients will receive 1 puff (equall to 1000 IU of interferon beta 1a)of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days Control group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine etc,..), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days The primary outcome was the evaluation of 50% reduction of viral load or negative results of virus before day 7. Timepoint: before drug administration, day 3, day 5, and day 7 (before negative result until day 7). Method of measurement: RT-PCR test. Number of days with fever (more than 37.2) up to 7 days. Timepoint: Daily up to day 7. Method of measurement: Thermometer. Number of days with dyspnea until day 7. Timepoint: Daily up to day 7. Method of measurement: Clinical examination by investigator or history review of the patients. Number of days that patients need supplemental oxygenation up to day 7. Timepoint: Daily up to day 7. Method of measurement: Examination by investigator. Change of laboratory results of patients before treatment and last day of study (day 7). Timepoint: Before drug administration and last day of study. Method of measurement: Laboratory results. Adverse events. Timepoint: Daily up to day 7. Method of measurement: Investigator report. Number of days that patients have dry cough. Timepoint: Daily until day 7. Method of measurement: Examination by investigator. CinnaGen company Approved 2020-05-02 Ethical Committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)