IRCT20200413047056N1.

Study name	Comparison between the efficacy of intravenous immunoglobulin and convalescent plasma in improving the condition of patients with COVID‐19: a randomized clinical trial
Methods	Trial design: randomised, clinical trial  Sample size: 15 Setting: hospitalised patients  Country: Iran Language: English Number of centres: 1
Participants	Inclusion criteria 18‐50 years old RT‐PCR Confirm the infection in the throat swab or sputum or lower respiratory tract samples Signed informed consent form on a voluntary basis Meet any of the following criteria for severe or critical ill conditions: respiratory rate ≥ 30/min; or rest SpO2 ≤ 90%; or PaO2/FiO2 ≤ 300 mmHg; or respiratory failure and needs mechanical ventilation; or multiple organ failure and needs ICU monitoring Exclusion criteria NR
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP: type of plasma: NR volume: 200 cc each time number of doses: 2 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): 3 arms: CP; IV immunoglobulin (400 mg/kg/d); this group will receive common national protocol Concomitant therapy: common national protocol Treatment cross‐overs: NR
Outcomes	Primary study outcome: lung involvement in X‐ray and CT‐scan, SpO2, LDH enzyme, viral load, acute phase protein, white blood cell count, erythrocyte sedimentation rate, length of hospital stay, duration of mechanical ventilation 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: yes QoL: NR Additional outcomes Lung involvement in X‐ray and CT‐scan SpO2 LDH enzyme Viral load Acute phase protein White blood cell count Erythrocyte sedimentation rate
Starting date	18 April 2020
Contact information	Malihe Zangoue, Birjand University of Medical Sciences, Birjadn, Iran; mzangoue@yahoo.com
Notes	Recruitment status: recruiting Prospective completion date: 15 August 2020 Sponsor/funding: Birjand University of Medical Sciences, Birjand, Iran