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IRCT20200405046958N2 IRCT 2021-04-14 Mashhad University of Medical Sciences Evaluation of the effect of plasmapheresis in the treatment of Covid 19 Evaluation of the effect of therapeutic plasma exchange in patients with acute respiratory distress syndrome caused by Covid 19 disease 2021-03-10 anticipated 42 Complete https://irct.ir/trial/54653 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: In this study,the control group will be retrospective and the previous data will be used, matching is done based on propensity score matching and this index is used in regression models to adjust for potential confounders. 2-3 Covid 19 induced acute respiratory distress syndrome. Intervention 1: Intervention group: Patients who underwent plasmapheresis for 3 days in addition to routine treatment (Includes ventilation supportive care, serum therapy, treatment with heparin or enoxaparin, famotidine or pantoprazole, low-dose dexamethasone, remdesivir, atorvastatin, and antibiotics if needed). Intervention 2: Control group: Patients who receive only the usual treatments listed. 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 more information at this time
public Mohammad Moeini nodeh
internal medicine department., Ghaem hospital., ahmadabad St
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2742 MoeiniNM@mums.ac.ir Mashhad University of Medical Sciences scientific Mohammad Moeini Nodeh
Ghaem hospital., Ahmad abad St
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2742 MoeiniNM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The patient must be definitive case of Covid-19 based on positive PCR test. The patient must have clinical and paraclinical criteria for acute respiratory distress syndrome (ARDS) The patient age must be over 15 years There must be the informed consent of the patient or his/her legal guardian 15 years no limit Both The patient has unstable hemodynamics The patient has a history of previous acute cardiac infarction in the last 3 months The patient has a history of allergies to blood products U07.1 Covid 19 virus identified Treatment - Other Treatment - Other Intervention group: Patients who underwent plasmapheresis for 3 days in addition to routine treatment (Includes ventilation supportive care, serum therapy, treatment with heparin or enoxaparin, famotidine or pantoprazole, low-dose dexamethasone, remdesivir, atorvastatin, and antibiotics if needed) Control group: Patients who receive only the usual treatments listed. Death. Timepoint: first 30 days of hospital admission. Method of measurement: examination of vital signs. Disease severity. Timepoint: 1st, 3rd and 7th day after ICU admission. Method of measurement: Use of SAPS3 and SOFA scoring systems. ICU ward stay. Timepoint: Day 30 and 60 from hospital admission. Method of measurement: Patient visit. Mechanical ventilation duration. Timepoint: All days of ICU admission. Method of measurement: Daily visit. Changes in CRP and Ferritin inflammatory markers. Timepoint: Days 0, 3 and 7 after ICU admission. Method of measurement: Serum levels of CRP and ferritin tests. Mashhad University of Medical Sciences Approved 2020-05-12 Ethics committee of Mashhad University of Medical Sciences Ghaem Hospital, Ahmad Abad street Mashhad Razavi Khorasan Iran (Islamic Republic of)