NCT04345991.

Study name	Cohort multiple randomized controlled trials open‐label of immune modulatory drugs and other treatments in covid‐19 patients ‐ CORIMUNO‐CORIPLASM: efficacy of convalescent plasma to treat SARS‐CoV2 infected patients
Methods	Trial design: randomised, parallel‐assignment Sample size: 120 (60 in each arm) Setting: early‐stage disease Country: France Language: English Number of centres: 1
Participants	Inclusion criteria Patients included in the CORIMUNO‐19 cohort Onset of COVID‐19 functional signs < 8 days (plasma transfusion may occur up to day 10 of onset) Mild severity as described in the WHO scale Exclusion criteria Pregnancy Current documented and uncontrolled bacterial infection Prior severe (grade 3) allergic reactions to plasma transfusion
Interventions	CP therapy or hyperimmune globulin therapy: CP Details of CP: type of plasma: details of preparation not described volume: 200‐220 mL number of doses: 2‐4 antibody‐titre: NR pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): early stage (within 10 days of symptom onset) For studies including a control group: comparator (type): standard of care Concomitant therapy: standard of care Treatment cross‐overs: not applicable
Outcomes	Primary study outcome: survival without needs of ventilator utilisation, WHO progression scale ≥ 6 at day 4 of randomisation 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): yes Number of participants with SAEs: yes 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: no (up to 28 days) Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: yes QoL: NR Additional outcomes WHO progression scale (time frame: at 4, 7 and 14 days after randomisation) Survival without needs of ventilator utilisation (time frame: at 4, 7 and 14 days after randomisation) Survival without use of immunomodulatory drugs (time frame: at day 14 after randomisation)
Starting date	14 April 2020
Contact information	Karine LACOMBE, PU‐PH +33 149283196 karine.lacombe2@aphp.fr
Notes	Recruitment status: not yet recruiting Prospective completion date: 1 June 2020 Sponsor/funding: Assistance Publique ‐ Hôpitaux de Paris