IRCT20200325046860N1.

Study name	Evaluation of convalescent plasma therapy in the treatment of patients with COVID‐19 disease
Methods	Trial design: non‐randomised, parallel group Sample size: 200 Setting: moderate to severe disease Country: Iran Language: English Number of centres: 4
Participants	Inclusion criteria  Blood oxygen saturation < 90% Abnormal lung CT scan Significant shortness of breath Fever Not improving in the next 48 h No possibility of discharge in the next 48 h Consent Exclusion criteria  Patient should not be connected to a ventilator Patient has not given consent
Interventions	CP therapy or hyperimmune globulin therapy: CP Details of CP: type of plasma: CP, preparation details not described (guideline of Iran blood transfusion organisation criteria), max 650 mL collected  volume: 500 mL number of doses: 1 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 treatment  Concomitant therapy: conventional treatment Treatment cross‐overs: none
Outcomes	Primary study outcome: improving respiratory function of patients Primary review outcomes All‐cause mortality at hospital discharge: yes Time to death: yes 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: yes (no follow‐up period stated) Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: yes  QoL: NR Additional study outcomes: NR
Starting date	15 March 2020
Contact information	Hassan Abolghasemi +98 21 8126 3166 h.abolghasemi.ha@gmail.com
Notes	Recruitment status: recruiting  Prospective completion date: 20 August 2020 (expected recruitment end date) Sponsor/funding: Darmanara Co, Iran Blood Transfusion Organization