NCT04357106.

Study name	COPLA Study: treatment of severe forms of coronavirus infection with convalescent plasma
Methods	Trial design: single‐arm, interventional Sample size: 10 Setting: ICU Country: Mexico Language: English Number of centres: 1
Participants	Inclusion criteria SARS‐CoV2 infection with serious evolution and in ICU With or without ventilatory assistance Treated or not with hydroxychloroquine 200 mg every 12 h Either sex > 18 years Signed informed consent Exclusion criteria Treated with the following medications: azithromycin, ritonavir/lopinavir, remdesivir, interferons, ruxolinitib, tocilizumab Severe kidney failure who require replacement therapy
Interventions	CP therapy or hyperimmune globulin therapy: CP therapy Details of CP: type of plasma: apheresis plasma volume: 200 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): none Concomitant therapy: with or without ventilation, hydroxychloroquine Treatment cross‐overs: none
Outcomes	Primary study outcome: lung injury (PaO2/FiO2 relation), overall survival Primary review outcomes All‐cause mortality at hospital discharge: yes (up to 30 days) Time to death: yes (up to 30 days) 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 (up to 7 days) Number of participants with SAEs: yes (up to 7 days) Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: NR 30‐day and 90‐day mortality: yes (up to 30 days) Admission on the ICU: yes (in ICU) Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional outcomes Lung injury defined as PaO2/FiO2 relation (time frame: 7 days)
Starting date	13 April 2020
Contact information	Juan Carlos Olivares‐Gazca, MD, MPH; 2222438100; jolivares@hsctmexico.com José Manuel Priesca‐Marin, MD; 2222438100; mpriesca@hsctmexico.com
Notes	Recruitment status: recruiting Prospective completion date: August 2020 Sponsor/funding: Centro de Hematología y Medicina Interna