IRCT20200310046736N1.

Study name	Comparison of the therapeutic effect of convalescent plasma and plasma‐derived immunoglobulin‐enriched solution on COVID‐19 patients
Methods	Trial design: a hospital‐based, parallel‐group, single‐blind, RCT Sample size: 45 Setting: inpatient Country: Iran Language: English Number of centres: 1
Participants	Inclusion criteria COVID‐19 patients who have the clinical signs of COVID‐19 infection such as fever, cough, sputum production, sore throat, and so on Positive CT scan Declare informed consent for this study Age: 20‐45 years Exclusion criteria Pregnant women (based on WHO protocol) Lactating women (based on WHO protocol) Individuals who exhibit specific allergic reactions to IV administration History of dangerous underlying diseases such as IgA deficiency History of dangerous diseases such as cardiovascular and or haematological disorders (haemophilia, thalassaemia, leukaemia) History of underlying diseases such as liver and kidney disease Smokers
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP: type of plasma: obtained from fully recovered patients according to inclusion criteria  volume: 200 cc/day IV administration for 1‐4 h number of doses: for 1‐4 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): randomised (3 arms): CP, plasma‐derived immunoglobulin‐enriched solution and best supportive care or routine care without any new therapeutic interventions Concomitant therapy: NR Treatment cross‐overs: NR
Outcomes	Primary study outcome: complete remission of clinical signs of disease (about 1 week after starting the treatment), negative result for COVID‐19 RT‐PCR test (7‐14 days after starting the treatment), normal CT scan (7‐14 days after starting the treatment) Primary review outcomes All‐cause mortality at hospital discharge: NR Time to death: NR 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: NR Time to discharge from hospital: NR QoL: NR Additional outcomes Negative result for COVID‐19 RT‐PCR test Normal CT scan Recovery and normal levels of biomarkers associated with COVID‐19
Starting date	24 March 2020
Contact information	Parastoo Moradi Choghakabodi, Iran (Islamic Republic of); parastoomoradi40@yahoo.com
Notes	Recruitment status: not yet recruiting Prospective completion date: 24 July 2020 Sponsor/funding: Ahvaz University of Medical Sciences, 61357‐15794 Ahvaz, Iran