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IRCT20201210049672N1 IRCT 2022-03-17 Vice-Chancellery for Research Hormozgan University of Medical Sciences Comparison of inhaled heparin/N-acetylcysteine, N-acetylcystein alone, and placepo for the treatment of COVID-19 patients Comparison of the efficacy of inhaled heparin/N-acetylcysteine, N-acetylcystein alone, and placepo for the treatment of COVID-19 patients admitted to the hospital 2022-03-11 anticipated 25 Complete https://irct.ir/trial/62519 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with individuals as units of randomization along with allocation concealment: 75 unclear envelopes and 75 cards with the names of the groups (A, B, C) will be prepared (25 cards for each group). The cards will be put into the envelopes and the envelopes will be sealed and provided to the investigator. Upon entrance of each patient to the study, the envelopes will be shuffled and one will randomly be selected. The patient will be allocated to group A, B, or C based on the card inside the selected envelope, Blinding description: A total of 5-ml vials will be prepared by an individual not involved in the study. Each 25 vials will be prepared based on the instructions for any of the three study groups. Then, a label indicating A, B, or C will be attached to each vial. The vials will be kept in an appropriated place and the investigator, the participants, the nurses responsible for drug administration, and all other individuals involved in the study will be unaware of the content of vials. 3 COVID-19. Intervention 1: Intervention group: Protocol treatments + 2 ml heparin from the 5000 IU vial and 3 ml N-acetyl cysteine 20% amounting to a total of nebulized 5 ml solution, every 4 hours, daily for 7 days. Intervention 2: Intervention group: Protocol treatments + 3 ml N-acetyl cysteine 20% and 2 ml distilled water amounting to a total of nebulized 5 ml solution, every 4 hours, daily for 7 days. Intervention 3: Control group: Protocol treatments + nebulized 5 ml distilled water , every 4 hours, daily 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 There is no further information.
public Bibimona Razavi
Jomhouri Eslami Blvd., Payambar Azam Hospital
Bandar Abbas Iran (Islamic Republic of) 9791991551 +98 76 3334 5009 bibimonarazavi.hums@gmail.com Bandare-abbas University of Medical Sciences scientific Bibimona Razavi
Jomhouri Eslami Blvd., Payambar Azam Hospital
Bandar Abbas Iran (Islamic Republic of) 979199155 +98 76 3334 5009 bibimonarazavi.hums@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Definitive COVID-19 diagnosis based on PCR results Admission to the intensive care unit no limit no limit Both Hypersensitivity to heparin and N-acetyl cysteine Coagulopathies B34.2 Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Placebo Intervention group: Protocol treatments + 2 ml heparin from the 5000 IU vial and 3 ml N-acetyl cysteine 20% amounting to a total of nebulized 5 ml solution, every 4 hours, daily for 7 days Intervention group: Protocol treatments + 3 ml N-acetyl cysteine 20% and 2 ml distilled water amounting to a total of nebulized 5 ml solution, every 4 hours, daily for 7 days Control group: Protocol treatments + nebulized 5 ml distilled water , every 4 hours, daily for 7 days Intensive care unit length of stay. Timepoint: At the end of the study. Method of measurement: Checklist. Tracheal intubation requirement. Timepoint: Any time during the study. Method of measurement: Checklist. Mechanical ventilation requirement. Timepoint: Any time during the study. Method of measurement: Checklist. Death. Timepoint: Any time during the study. Method of measurement: Checklist. Vice-Chancellery for Research Hormozgan University of Medical Sciences Approved 2021-04-19 Ethics committee of Hormozgan University of Medical Sciences Imam Hossein Blvd., across from Kargaran Sports Complex, Faculty of Medicine Bandar Abbas Hormozgan Iran (Islamic Republic of)