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. 2020 Jul 10;2020(7):CD013600. doi: 10.1002/14651858.CD013600.pub2

NCT04372979.

Study name Evaluation of efficacy of COVID‐19 convalescent plasma versus standard plasma in the early care of COVID‐19 patients hospitalized outside intensive care units
Methods Trial design: triple‐blinded, parallel, clinical RCT
Sample size: 80
Setting: inpatient
Country: France
Language: translated to English
Number of centres: at least 4
Participants Inclusion criteria:

  • Age 18‐80 years

  • COVID‐19‐confirmed case

  • Cases showing respiratory symptoms, checking at least 1 of the following criteria:

    • Cough, dyspnoea, respiratory rate > 24 breaths/min

    • Oxygen saturation < 95% at rest in ambient air

    • PaO2 < 70 mmHg

    • Scanographic pulmonary compatible with COVID in the absence of any other aetiology

  • Risk of deterioration, checking at least 1 of the following comorbidity criteria:

    • Chronic respiratory pathology

    • Diabetes

    • Cancer pathology

    • Cardiovascular disease

    • Chronic kidney failure

    • Congenital or acquired immunodeficiency

    • Cirrhosis at stage B

    • Major sickle cell syndrome

    • BMI > 30 kg/m2


OR 1 of the biological criteria :

  • D‐dimer 1 µg/mL

  • Lymphocytes < 0.8 G/L

  • Ferritin > 300 µg/L

  • Troponin I > 11 pg/mL


Exclusion criteria:

  • Patients admitted in ICU within the first 6 h of hospital care

  • Patients after 10 days from the start of symptoms

  • Age < 18 years and > 80 years

  • Long‐term oxygen‐dependent patients (at home)

  • Decompensated chronic cardiac, respiratory, urological pathology

  • Patient refusing administration of blood products

  • Allergic reaction to plasma products

  • IgA deficiency

  • Contraindication to transfusion

  • Ig transfusion within 30 days

  • Patient currently participating to another clinical trial

  • Pregnant women

  • Not affiliated to the social security

  • Person deprived of liberty by a legal or administrative decision, person under guardianship
Interventions

  • Intervention(s): transfusion of SARS‐CoV‐2 CP

    • Details of CP: SARS‐CoV‐2 CP

    • Type of plasma: 

    • Volume: 200‐230 mL

    • Number of doses: 2 infusions be administered with 24‐72 h in between

    • Antibody‐titre: NR

    • Pathogen inactivated: by amotosalen

  • Treatment details, including time of plasma therapy (e.g. early stage of disease): NR

  • Comparator: standard plasma

  • Concomitant therapy: NR

  • Treatment cross‐overs: no
Outcomes

  • Primary study outcome: survival time without need of a ventilator (time frame: day 30)

  • Primary review outcomes reported

    • All‐cause mortality at hospital discharge: 30‐day mortality without need of a ventilator

    • Time to death: NR

  • Secondary review outcomes reported

    • 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: NR

    • 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 (length of stay (time frame: day 30)

    • QoL: NR

  • Additional study outcomes

    • Morbidity (time frame: Day 15)

    • Morbidity (time frame: Day 30)

    • Effect on viral pharyngeal specimen clearance (time frame: at inclusion and Day 7)

    • Effect on viral blood specimen clearance (time frame: at inclusion and Day 7)

    • Effect on haemostasis disorders (time frame: at inclusion, Day 1 and every 48 h)

    • Kinetics of appearance of neutralising antibodies (time frame: at inclusion, Day 7)

    • Transfusion endotheliopathy effect (time frame: at inclusion, Day 1, Day 7)

    • Transfusion biological inflammation effect (time frame: at inclusion, Day 1, Day 7)

    • Transfusion haemovigilance (time frame: 30 days)

    • Decrease in the consumption of antibiotics (time frame: 30 days)
Starting date May 2020
Contact information Contact: Christophe MARTINAUD, PU PH +33 141467241christophe.martinaud@intradef.gouv.fr
Contact: Christophe RENARD +33 140514103christophe1.renard@intradef.gouv.fr
Notes Recruitment status: not yet recruiting
Prospective completion date: October 2020
Sponsor/funding: Direction Centrale du Service de Santé des Armées, University Hospital, Grenoble; Investigators Study Director:Hervé FOEHRENBACHDirection Centrale du Service de Santé des Armées (DCSSA), Study Director:Catherine VERRETService de Santé des Armées‐Direction de la Formation de la Recherche et de l'Innovation, Principal Investigator:Christophe MARTINAUDCentre de Transfusion Sanguine des Armées, Principal Investigator:Jean‐Luc BOSSONStatistical and methodological investigator ‐ Laboratoire TIMC UMR 5525 CNRS Equipe Themas