NCT04332835.

Study name	Convalescent plasma for patients with COVID‐19: a randomized, open label, parallel, controlled clinical study (CP‐COVID‐19)
Methods	Trial design: randomised, open‐label, parallel‐controlled trial Sample size: 40 in each arm (80) Setting: hospital Country: Colombia Language: English Number of centres: 1
Participants	Inclusion criteria   Aged 18‐60 years, male or female Hospitalised participants with diagnosis of COVID 19 by RT‐PCR Moderate cases according to the official guideline 'Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)' Confusion, urea, respiratory rate, blood pressure‐65 score (CURB‐65 score) ≥ 2 SOFA < 6 Ability to understand and the willingness to sign a written informed consent document Exclusion criteria Pregnant or breastfeeding Prior allergic reactions to transfusions Critically ill patients in ICUs Patients with surgical procedures in the last 30 days Patients with active treatment for cancer (radiotherapy or chemotherapy) HIV‐diagnosed patients with viral failure (detectable viral load > 1000 copies/mL persistent, 2 consecutive viral load measurements within a 3‐month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals) Suspicion or evidence of co‐infections End‐stage chronic kidney disease (GFR < 15 mL/min /1.73 m2) Child Pugh C stage liver cirrhosis High cardiac output diseases Autoimmune diseases or IgA nephropathy Any condition that in the judgement of the Investigators would make the patient inappropriate for entry into this study
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP therapy Details of CP: type of plasma: NR volume: 500 mL total 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): azithromycin (500 mg daily) and hydroxychloroquine (400 mg every 12 h) for 10 days Concomitant therapy: azithromycin (500 mg daily) and hydroxychloroquine (400 mg every 12 h) for 10 days Treatment cross‐overs: not applicable
Outcomes	Primary study outcome: change in viral load, change in immunoglobulin M COVID‐19 antibodies titres, change in immunoglobulin G COVID‐19 antibodies titres Primary review outcomes All‐cause mortality at hospital discharge: yes (7, 14, 28 day mortality) 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: yes Length of stay on the ICU: yes Time to discharge from hospital: yes QoL: NR Additional outcomes Change in viral load Change in immunoglobulin M COVID‐19 antibodies titres Change in immunoglobulin G COVID‐19 antibodies titres Clinical status assessed according to the WHO guideline
Starting date	1 May 2020
Contact information	Juan M Anaya Cabrera, MD, PhD; +57 321 233 9828; anayajm@gmail.com    Manuel E Rojas Quintana, MD, MSc; +57 315 459 9951; manuel_9316@hotmail.com
Notes	Recruitment status: not yet recruiting Prospective completion date: 31 December 2020 Sponsor/funding: Universidad del RosarioFundación Universitaria de Ciencias de la SaludCES UniversityInstituto Distrital de Ciencia Biotecnología e Innovacion en Salud