NCT04352751.

Study name	Experimental use of convalescent plasma for passive immunization in current COVID‐19 pandemic in Pakistan in 2020
Methods	Trial design: single‐arm, interventional  Sample size: 2000 Setting: moderate‐severe cases Country: Pakistan Language: English Number of centres: 1 reported
Participants	Inclusion criteria Informed consent must have been obtained Confirmed COVID‐19 cases confirmed by RT‐PCR laboratory tests Moderately severe or severe life‐threatening COVID‐19 related features: moderately severe disease as defined by the following features: shortness of breath; respiratory rate ≥ 30/min; arterial blood oxygen saturation ≤ 92%,; and/or lung infiltrates > 25% within 24‐48 h severe life‐threatening disease as defined by the presence of any of the following features: respiratory failure; shock; multiple organ dysfunction Exclusion criteria Allergy history of plasma, sodium citrate and methylene blue For patients with history of autoimmune system diseases or selective IgA deficiency, the application of CP should be evaluated cautiously by clinicians Patients having evidence of uncontrolled cytokine release syndrome leading to end‐stage multiorgan failure
Interventions	CP therapy or hyperimmune globulin therapy: CP Details of CP: type of plasma: standard apheresis plasma collection protocol using Haemonetics MCS+ intermittent blood flow system or Terumo Optia, Cobe‐Spectra, Trima or Fresenius continuous flow system to be used. 900‐1000 mL collected each time volume children: 15 mL/kg over 4‐6 h once in patients under 35 kg body weight adults: maximum 450‐500 mL over 4‐6 h once in all adult patients 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): none Concomitant therapy: NR Treatment cross‐overs: none
Outcomes	Primary study outcome: change in COVID‐19 severity status (for categories: see additional outcomes) 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): yes (information will be recorded) Number of participants with SAEs: yes (information will be recorded) Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: yes (up to 4 weeks post‐treatment) 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 Change in COVID‐19 severity status (time frame: up to 9 days). Improvement in disease severity will be regarded as a shift from critical to severe or from severe to mild disease category. The various disease categories are defined as following: mild COVID‐19, defined by the absence of features given in criteria for moderate and severe disease severe COVID‐19, defined by the presence of any of the following features: shortness of breath; respiratory rate ≥ 30/min; arterial blood oxygen saturation ≤ 93%; lung infiltrates > 50% within 24‐48 h critical COVID‐19, defined by the presence of any of the following features: respiratory failure; shock; multiple organ dysfunction
Starting date	April 2020
Contact information	Contact: Dr. Arshi Naz, PhD,Diplab; 00923232234376; labarshi@yahoo.com Contact: Dr. Neeta Maheshwary, MBBS M.Phil; 00923208247773; drneeta@hiltonpharma.com
Notes	Recruitment status: not yet recruiting  Prospective completion date: April 2021 Sponsor/funding: Hilton Pharma