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IRCT20200404046948N1 IRCT 2020-04-15 Artesh University of Medical Sciences Efficacy and safety of convalescent plasma in the treatment of COVID-19 Randomized, parallel-controlled and multi-center clinical study evaluating the efficacy and safety of convalescent plasma, in the treatment of patients with severe SARS-CoV-2 infection (COVID-19) 2020-04-13 anticipated 60 Complete https://irct.ir/trial/46973 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: ُُSimple randomization by computerized random number generation will be used. A list of sequentially number 1 to 60 will be created. This list will align numbers randomly by computer. Patients are randomly assigned to the experimental group (conventional treatment combined with convalescent plasma treatment group) or the control group (conventional treatment group) according to the numbers of this list. 3 Novel Coronavirus Pneumonia (COVID-19)Coronavirus (COVID-19). Intervention 1: Intervention group: patients in this group (Laboratory confirmed COVID-19 by PCR), will receive conventional therapy with Infusion of convalescent plasma, 200-500ml, two IV infusions during two consecutive days. Intervention 2: Control group: Laboratory confirmed COVID-19 by PCR only receive conventional therapy. Yes - There is a plan to make this available What will be shared: After the publication of the article and removing confidential information like patients and hospital information, other information will be made available to researchers When: After publication of the article To whom: Medical professionals Conditions: Medical professionals can access data for research purposes Where to obtain: Refer to the email of the responsible author. How to obtain: Official and academic email to the responsible author Comments:
public Ramin Hamidi Farahani
Etemadzadeh avenue; West Fatemi street
TEHRAN Iran (Islamic Republic of) 1411718541 +98 21 8609 6356 Amir.salarian@gmail.c0m Artesh University of Medical Sciences scientific Ramin Hamidi Farahani
Etemadzadeh avenue; West Fatemi street
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6356 rgsramin@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Laboratory confirmed COVID-19 by PCR Aged 18 to 70 years old Being inpatients The clinical severe or immediately life-threatening COVID-19 (Severe patients meet any of the following: Dyspnea, Respiratory frequency ≥ 30/min, Blood oxygen saturation ≤ 93% (in resting state), partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2)<300, and/or Lung infiltrates > 50% within 24 to 48 hours. Life-threatening disease is defined as: respiratory failure and need mechanical ventilation, septic shock, and/or multiple organ dysfunction or failure The patient or his/her legal guardian will sign the informed consent and participate voluntarily Accepting randomized allocation (allocating into any group) Being hospitalized before the end of the clinical trial and available for any follow-up 18 years 70 years Both Those who has history of allergy to blood products or plasma components and auxiliary materials (sodium citrate) Critical conditions like multiple organ failure, and the estimated survival time is less than 3 days Severe congestive heart failure (CHF), or any other conditions in which plasma transfusion is contraindicated decided by researchers Any risk factor which may increase the risk of thrombosis, Pregnant or breastfeeding women Participation in another clinical trial Taking any other medicine for COVID 19 treatment out of the protocol The doctor believes that the patient is not suitable to participate in this trial U07.1 COVID-19, virus identified Treatment - Other Treatment - Other Intervention group: patients in this group (Laboratory confirmed COVID-19 by PCR), will receive conventional therapy with Infusion of convalescent plasma, 200-500ml, two IV infusions during two consecutive days. Control group: Laboratory confirmed COVID-19 by PCR only receive conventional therapy Clinical improvement within 14 days of admission. Timepoint: everyday. Method of measurement: Clinical improvement is defined as the patient's admission status of 6 grade scale score reduced by 2 points or patient discharge. (Clinical improvement was defined as a 2-point reduction or discharge of a 6-point scale for patient admission status. The 6-point scale includes: 6 points: death; 5 points: hospitalization for ECMO and / or mechanical ventilation; 4 points: non-invasive admission Ventilation and / or high-flow oxygen therapy; 3 points: hospitalization for oxygen therapy (but no high-flow or non-invasive ventilation is required); 2: points for hospitalization) Point1: discharge. Mortality in a two groups during 14 days. Timepoint: everyday. Method of measurement: Examination and history. Hospitalization ِِDuration. Timepoint: Patient discharge day. Method of measurement: Examination and history. ICU Hospitalization Duration. Timepoint: everyday. Method of measurement: Examination and history. Invasive mechanical ventilation. Timepoint: everyday. Method of measurement: Examination and history. ECMO duration. Timepoint: everyday. Method of measurement: Examination and history. Proportion of PCR negative (3 AND 7 days after transfusion). Timepoint: 3 days and 7 days after injection. Method of measurement: PCR. Clinical characteristics including, Fever, Respiratory frequency(RF) and PaO2/FiO2. Timepoint: everyday. Method of measurement: Examination and history. Artesh University of Medical Sciences Approved 2020-03-28 AJA University of Medical Sciences Etemadzadeh avenue; West Fatemi street Tehran Tehran Iran (Islamic Republic of)