COVID-19 trials registries data warehouse

http://en.irct.ir/trial/46973

Ramin Hamidi Farahani

rgsramin@yahoo.com

2020-04-15

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

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

2

Artesh University of Medical Sciences

18

70

Iran

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

60

Clinical improvement within 14 days of admission

Phase 3

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