IRCT20151228025732N53.

Study name	Evaluation of the therapeutic effects of convalescent plasma (CP) of recovered people from COVID‐19 in improving clinical and laboratory symptoms of hospitalised patients
Methods	Trial design: non‐randomised, parallel group Sample size: 12 (6 control 6 intervention) Setting: inpatient Country: Iran Language: English Number of centres: 1
Participants	Inclusion criteria  Patients admitted to the ICU who receive mechanical invasive or non‐invasive ventilation, Pa02/FiO2 ratio < 300 mmHg (93%). Currently receiving IV vasoactive medications to maintain mean arterial pressure > 65 mmHg; respiratory frequency ≥ 30/min; laboratory‐confirmed COVID‐19 infection (by real‐time PCR) Exclusion criteria Negative real‐time PCR from respiratory secretions or blood within 48 h prior to CP transfusion  History of allergic reaction to blood or plasma products Known IgA deficiency
Interventions	CP therapy or hyperimmune globulin therapy: CP  Details of CP: type of plasma: CP, prepared from recovered patients volume: 2 units  number of doses: 2 antibody‐titre: > 1:320 pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): hospitalised participants For studies including a control group: comparator (type): conventional treatment Concomitant therapy: conventional treatment  Treatment cross‐overs: none
Outcomes	Primary study outcome: checking the amount of ventilation, white blood cell count, CRP, percentage of CD8+ T cells in peripheral blood, percentage of CD4+ T cells in peripheral blood 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 min after intervention and daily) 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: white blood cell count, CRP, percentage of CD8+ T cells in peripheral blood, percentage of CD4+ T cells in peripheral blood
Starting date	20 April 2020
Contact information	Alireza Emadi Semnan University of Medical Sciences, Semnan, Iran +98 23 3345 1336 are20935@semums.ac.ir
Notes	Recruitment status: recruiting Prospective completion date: 20 June 2020 (recruitment end date) Sponsor/funding: Semnan University of Medical Sciences