COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05271929

Eric Toussirot, MD, PhD

etoussirot@chu-besancon.fr

2022-03-09

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

cohort 1: elderly and high covid-age population: inclusion criteria: sars-cov-2 rna detected in a specimen, ≤ 7 days after onset of symptoms symptoms of covid-19 (so including but not limited to: fever; cough; breathlessness; chest pain; wheeze; sore throat; haemoptysis; runny nose; fatigue; muscle or joint pain; confusion; headache; seizures; nausea; vomiting; diarrhoea; abdominal pain; poor appetite; skin ulcers or rash; ear pain; conjunctivitis; anosmia; bleeding; lymphadenopathy. the attending clinician will determine if symptoms are consistent with covid-19. clinical status not requiring admission to hospital for covid-19 disease and oxygen support ability to transfuse (per randomisation) within 7 days after onset of symptoms men or women, 70 years or older or under 70 years with significant comorbidities (arterial hypertension, diabetes, obesity, asthma or other chronic pulmonary disease, cardiovascular disease, cerebrovascular disease, chronic kidney disease / dialysis, hemoglobinopathies, liver disease, chronic neurological disease, rheumatoid arthritis, lupus or psoriasis) resulting in a 'covid-age' of 70 years or more according to the alama risk calculator https://alama.org.uk/covid-19-medical-risk-assessment/

age < 18 years (france and germany only) prior or concurrent treatment for covid-19 (unless listed as authorized) history of covid-19 disease in the last 90 days prior to enrollment prior anti-sars-cov-2 immunization contraindication to receiving ccp including previous history of transfusion-related acute lung injury (trali) or moderate or severe allergic reaction to blood components known participant objection to receiving plasma products primary or acquired immune deficiency listed below (see cohort 2) refusal to participate expressed by patient or legally authorised representative pregnancy cohort 2: high-risk immunocompromised population inclusion criteria: sars-cov-2 rna detected in a specimen, ≤ 7 days after onset of symptoms symptoms of covid-19 (so including but not limited to: fever; cough; breathlessness; chest pain; wheeze; sore throat; haemoptysis; runny nose; fatigue; muscle or joint pain; confusion; headache; seizures; nausea; vomiting; diarrhoea; abdominal pain; poor appetite; skin ulcers or rash; ear pain; conjunctivitis; anosmia; bleeding; lymphadenopathy. the attending clinician will determine if symptoms are consistent with covid-19. clinical status not requiring admission to hospital for covid-19 disease and oxygen support ability to transfuse (per randomisation) within 7 days after onset of symptoms male or female with extremely high risk including: a. patients with at least one of the following acquired immune deficiencies i. lymphoid malignancies treated within the last 12 months ii. lymphoid malignancies with persistent hypogammaglobulinaemia (igg < 5g/l) iii. myeloid malignancies treated by chemotherapy within the last 12 months iv. myeloid malignancies treated by anti-bcl-2 drugs within the last 12 months v. myeloid malignancies associated with prolonged neutropenia (≥ 6 weeks) vi. solid tumour undergoing treatment with chemotherapy (until 3 months after completion of the last chemotherapy cycle) vii. allogenic hematopoietic stem cell transplantation within the last 12 months or anytime if on-going treatment for chronic gvhd viii. organ transplantation ix. anti-b (cd20/cd19) moab and/or mycophenolate mofetil treatment within the last 12 months x. anti-cd19/cd20 car-t cell treatment xi. atg or alemtuzumab treatment within the last 6 months xii. aids or b. patients with primary lymphoid immune deficiencies. i. b cell deficiencies (such as bruton agammaglobulinemia) ii. t cell deficiencies (such as wiskott aldrich disease) iii. combined deficiencies (such as common variable immunodeficiency). or c. patients without detectable seroconversion ≥ 3 weeks after complete vaccination schedule with an approved vaccine.

2

Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen

18

100

France;Germany;Netherlands;United Kingdom

Mild disease at enrollment

1: Mild disease at enrollment

680

Proportion of participants with hospitalisation with progressive COVID-19 symptoms or death

None

Phase 3

[{"arm_notes": "nan", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]