Status:
TERMINATED
Early High-Titre Convalescent Plasma in Clinically Vulnerable Individuals With Mild COVID-19
Lead Sponsor:
Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen
Collaborating Sponsors:
NHS Blood and Transplant
Erasmus Medical Center
Conditions:
COVID-19
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
* Research Question: Does convalescent plasma (CCP) collected from donors who have recovered from COVID-19 and who have a very high titre of anti-SARS-CoV-2 antibodies reduce the risk of hospitalisati...
Detailed Description
COVIC-19 is a multicentre international, randomised, open-label adaptive superiority phase III trial to evaluate the efficacy and safety of COVID-19 convalescent plasma in the treatment of COVID-19. I...
Eligibility Criteria
Inclusion
- 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/
- Exclusion Criteria:
- 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, or positive antigenic test, 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.
- Exclusion Criteria:
- Age \< 18 years (France and Germany only)
- Prior or concurrent treatment for COVID-19 (dexamethasone, anti-IL-6/IL6R, remdesivir) except for prophylactic administration of anti-SARS-CoV-2 monoclonal antibodies (pre or post exposure) and authorized specific treatment
- History of COVID-19 disease in the last 90 days prior to enrollment
- 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
- Refusal to participate expressed by patient or legally authorised representative
- Pregnancy
Exclusion
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05271929
Start Date
April 1 2022
End Date
June 17 2024
Last Update
October 29 2024
Active Locations (14)
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1
CHU Besançon
Besançon, France, 25000
2
Stauferklinikum Schwäbisch Gmünd
Mutlangen, Baden-Wurttemberg, Germany, 73527
3
Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, Germany, 70174
4
Diakonie-Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, Germany, 70176