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IRCT20200409047007N1 IRCT 2020-04-12 Mashhad University of Medical Sciences Effect of COVID 19 survivors plasma in COVID 19 patients with ARDS The effect of plasma administration of COVID-19 survivors in patients with acute respiratory distress syndrome due to COVID-19 2020-04-13 anticipated 64 Complete https://irct.ir/trial/47058 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A COVID-19 Disease. Intervention 1: Intervention group: In the intervention group, patients, in addition to the current standard treatments, also receive 600 cc survivor's plasma. For the preparation of fresh plasma products, survivors with 18 to 60 years old were contacted and tested for CRP, CBC, HBS Ag, HCV Ab, HIV Ab, HTLV1 Ab, COVID 19 PCR and COVID 19 IgM & IgG antibody if they were without symptoms for at least 14 days. If all tests are normal, 600 cc plasma will be taken from them and are prescribed to patients in less than 12 hours. Survivors should have a positive initial PCR test for coronavirus, be male, or have no history of pregnancy if they are female. The donor and the patient must be the same in blood group. Intervention 2: Control group: Patients in the control arm are selected based on information recorded in the university registry system and will be similar to the control group in terms of age, sex, underlying disease and severity of respiratory disease. In the control arm, the necessary care and first-line therapies such as corticosteroids, antibiotics, and hydroxychloroquine will be prescribed according to the current symptoms. Yes - There is a plan to make this available What will be shared: After collecting and analyzing the data, the results will be made available to the public in the form of articles. When: After the publication of the article To whom: physicians Conditions: There are no restrictions Where to obtain: 1- Dr Abolghasem Allahyari, Mashhad University of Medical Science 2- Dr Mohsen Seddigh Shamsi, Mashhad University of Medical Science How to obtain: Refer to the project supervisor Comments:
public Dr Mohsen Seddigh Shamsi
Department of Internal Medicine, Taqi abad Square, Mashhad
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3859 8818 seddighshamsim@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Abolghasem Allahyari
Department of Internal Medicine, Taqi abad Square, Mashhad
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3859 8818 allahyaria@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Po2 / FIO2 ratio less than 300 despite receiving standard treatment The patient should be between 18 and 75 years old Normal IgA level Less than a week has passed since the patient entered the ICU 18 years 75 years Both Uncontrolled HTN Advanced heart failure Systolic blood pressure less than 90 mm Hg COPD The patient is intubated Chronic renal failure with GFR less than 30 Advanced hepatic failure U07.02 COVID-19 Disease Treatment - Other Treatment - Other Intervention group: In the intervention group, patients, in addition to the current standard treatments, also receive 600 cc survivor's plasma. For the preparation of fresh plasma products, survivors with 18 to 60 years old were contacted and tested for CRP, CBC, HBS Ag, HCV Ab, HIV Ab, HTLV1 Ab, COVID 19 PCR and COVID 19 IgM & IgG antibody if they were without symptoms for at least 14 days. If all tests are normal, 600 cc plasma will be taken from them and are prescribed to patients in less than 12 hours. Survivors should have a positive initial PCR test for coronavirus, be male, or have no history of pregnancy if they are female. The donor and the patient must be the same in blood group. Control group: Patients in the control arm are selected based on information recorded in the university registry system and will be similar to the control group in terms of age, sex, underlying disease and severity of respiratory disease. In the control arm, the necessary care and first-line therapies such as corticosteroids, antibiotics, and hydroxychloroquine will be prescribed according to the current symptoms. Mortality rate in 4 weeks from the time of entry into the study. Timepoint: The first month of entering the study. Method of measurement: Continuous clinical evaluation. The length of hospital stay in the ICU from the time of entering the study. Timepoint: Daily evaluation. Method of measurement: Clinical evaluation. Mashhad University of Medical Sciences Approved 2020-04-06 Ethics committee of Mashhad University of Medical Sciences Central University Building, University Street, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)