IRCT20200404046948N1.

Study name	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)
Methods	Trial design: open‐label, RCT  Sample size: 60 Setting: hospitalised patients  Country: Iran Language: English Number of centres: 4
Participants	Participants Inclusion criteria Laboratory‐confirmed COVID‐19 by PCR Aged 18‐70 years old Inpatients Clinical severe or immediately life‐threatening COVID‐19 (severe patients meet any of the following: dyspnoea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93% (in resting state), PaO2/FiO2 < 300, and/or lung infiltrates > 50% within 24‐48 h Life‐threatening disease is defined as: respiratory failure and need mechanical ventilation, septic shock, and/or multiple organ dysfunction or failure Patient or his/her legal guardian will sign the informed consent and participate voluntarily Accepting randomised allocation (allocating into any group) Being hospitalised before the end of the clinical trial and available for any follow‐up Exclusion criteria 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 < 3 days Severe congestive heart failure, or any other conditions in which plasma transfusion is contraindicated decided by study authors Any risk factor that 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 Doctor believes that the patient is not suitable to participate in this trial
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP: type of plasma: NR  volume: 200‐500 mL number of doses: 2 IV infusions during 2 consecutive days antibody‐titre: NR pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR For studies including a control group: comparator (type): conventional therapy and CP or conventional therapy only Concomitant therapy: conventional therapy  Treatment cross‐overs: NR
Outcomes	Primary study outcome: clinical improvement within 14 days of admission Primary review outcomes All‐cause mortality at hospital discharge: yes  Mortality in 2 groups during 14 days Time to death: NR, 14 days only Secondary review outcomes Number of participants with grade 3 and grade 4 AEs, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions): NR Number of participants with SAEs: NR Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: yes 30‐day and 90‐day mortality: NR Admission on the ICU: NR Length of stay on the ICU: yes Time to discharge from hospital: yes QoL: NR Additional outcomes Proportion of PCR‐negative (3 and 7 days after transfusion) Clinical characteristics including fever, respiratory frequency and PaO2/FiO2
Starting date	13 April 2020
Contact information	Ramin Hamidi Farahani, Artesh University of Medical Sciences, Tehran, Iran; Amir.salarian@gmail.com
Notes	Recruitment status: recruiting Prospective completion date: 20 June 2020 Sponsor/funding: Artesh University of Medical Sciences, 1411718541 Tehran, Iran