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IRCT20091201002804N12 IRCT 2020-06-01 Shahid Beheshti University of Medical Sciences The effect of surfactant on clinical outcome of patients with COVID-19 The effect of surfactant on clinical outcome of patients with COVID-19 under mechanical ventilation 2020-04-20 anticipated 60 Complete https://irct.ir/trial/46983 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: COVID-19 treatment study, Randomization description: After the participant enters the study, i.e. after the qualification of the patients in the trial is confirmed and their informed written consent is taken, simple randomization will be done as follows: 1- Table of random numbers will be used for creation of coincidence of random allocation. 2- In order to hide the random allocation process, the central randomization approach will be used, while the random sequence would be at the disposal of one of the researchers except for the principal investigator, Blinding description: participants after entering the study would not know whether they are in the drug or placebo group healthcare providers (Physicians and nurses) would administer the prepared vial including drug or placebo while they do not know its content; the vial would be assimilated; regardless of drug or placebo principle investigator does not know whether the patient belongs to the drug group or the placebo group since the patients have been randomized. 3 Mortality of Patients from COVID-19. Intervention 1: Intervention group: Intra-tracheal surfactant in COVID-19 patients who are under mechanical ventilation, which includes the administration of a standard dose of surfactant inside the airway of the patient with COVID-19 diagnosis, which is administered immediately on the first day of intubation and in two doses at intervals within 6 hours. The dose of the drug is a vial containing 4 ml, equivalent to 100 mg, which is prescribed for an adult weighing about 70 kg each time, and if the patient's weight is higher, it will be adjusted accordingly. The drug is from the brand Beraksurf® and is supplied by Tekzima. Intervention 2: Control group: all the treatment protocols including standard of care is the same as the treatment group; except for the intrathecal administration of surfactant. An equivalent volume of normal saline is used as placebo. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: starting in January 2022 To whom: the data would be available for people working in academic institutions and people working in businesses Conditions: by formal permission form PI Where to obtain: Address of the Principal Investigator How to obtain: Formal application confirmed by the institution Comments:
public Ali Dabbagh
Sa'adat Abad
Tehran Iran (Islamic Republic of) 1998738341 +98 21 2387 2202 alidabbagh@yahoo.com Shahid Beheshti University of Medical Sciences scientific Ali Dabbagh
Sa'adat Abad
Tehran Iran (Islamic Republic of) 1998738341 +98 21 2207 4101 alidabbagh@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) if the patient is intubated and under mechanical ventilation with SpO2<85% If the patient has confirmed COVID-19 18 years 99 years Both Coexisting underlying pulmonary disease except for COVID-19 Underlying congenital hear disease U07.1 COVID-19 Treatment - Drugs Placebo Intervention group: Intra-tracheal surfactant in COVID-19 patients who are under mechanical ventilation, which includes the administration of a standard dose of surfactant inside the airway of the patient with COVID-19 diagnosis, which is administered immediately on the first day of intubation and in two doses at intervals within 6 hours. The dose of the drug is a vial containing 4 ml, equivalent to 100 mg, which is prescribed for an adult weighing about 70 kg each time, and if the patient's weight is higher, it will be adjusted accordingly. The drug is from the brand Beraksurf® and is supplied by Tekzima. Control group: all the treatment protocols including standard of care is the same as the treatment group; except for the intrathecal administration of surfactant. An equivalent volume of normal saline is used as placebo Time for mechanical ventilation. Timepoint: throughout the study, the time that patient has stayed under mechanical ventilation. Method of measurement: clinical records. ICU mortality rate. Timepoint: throughout the study in the ICU ward. Method of measurement: clinical records. Shahid Beheshti University of Medical Sciences Approved 2020-03-28 Shahid Beheshti University of Medical Sciences Deputy for Research and Technology, Shahid Beheshti University of Medical Sciences, Velenjak Tehran Tehran Iran (Islamic Republic of)