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IRCT20081019001369N6 IRCT 2020-05-17 Mashhad University of Medical Sciences Clinical trial of trans sodium crocetinate against COVID-19 Evaluation of the effect of trans sodium crocetinate in respiratory distress caused by COVID-19 2020-06-21 anticipated 30 Complete https://irct.ir/trial/47188 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomized method according to randome numbers table. 2 Covid-19. Intervention 1: Intervention group: In addition to the standard treatment regimen for COVID-19, the trans sodium crocetinate 1 mg/kg/day will be given i.v. for 1 weeks. Intervention 2: Control group: Patients will received the standard treatment regimen for COVID-19 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 I haven't decided yet - the release schedule is not clear yet
public Amirhoushang Mohammadpour
School of Pharmacy, Vakilabad 2 Blvd.
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1592 MohamadpoorAH@mums.ac.ir Mashhad University of Medical Sciences scientific Hossein Hosseinzadeh
School of Pharmacy, Vakilabad 2 Blvd.
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1193 hosseinzadehh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with clinical diagnosis for Covid-19 disease, Patients with acute respiratory distress syndrome (ARDS), Patients not having kidney, liver and heart dysfunction according to clinical and laboratory findings PF ratio (the ratio of arterial oxygen partial pressure to fractional inspired oxygen) <300 , 18 years 65 years Both Allergic reactions to saffron Pregnancy or breast-feeding Multi organ dysfunction disease U07.1 COVID-19 Disease Treatment - Drugs Treatment - Drugs Intervention group: In addition to the standard treatment regimen for COVID-19, the trans sodium crocetinate 1 mg/kg/day will be given i.v. for 1 weeks. Control group: Patients will received the standard treatment regimen for COVID-19 for 7 days. Patients' mortality rate. Timepoint: During 7 days hospitalization. Method of measurement: Meedical Reports. Days under ventilation. Timepoint: During 7 days hospitalization. Method of measurement: Meedical Reports. Hospitalization days in ICU. Timepoint: During 7 days hospitalization. Method of measurement: Medical Report. Getting multi organ dysfunction. Timepoint: During 7 days hospitalization. Method of measurement: Clinical and laboratory evaluation. Improving PF ration. Timepoint: daily during 7 days hospitalization. Method of measurement: ratio calculated from PaO2/FiO2. Improving Sofa (The sequential organ failure assessment ) score. Timepoint: the first day and during 7 days hospitalization. Method of measurement: According to clinical and laboratory evaluation. Mashhad University of Medical Sciences Approved 2020-05-09 Medical Ethics Committee of Mashhad University of Medical Sciences School of Pharmacy, Vakilabad 2- Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)