Status:
UNKNOWN
Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19
Lead Sponsor:
Carsten Müller-Tidow
Collaborating Sponsors:
German Federal Ministry of Education and Research
Institut für Klinische Transfusionsmedizin und Zelltherapie Heidelberg gGmbH
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study RECOVER is a randomized, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment ...
Detailed Description
The aim of this randomized phase-II study is to gain evidence on the effect of convalescent plasma/vaccine-boosted plasma in the treatment of SARS-CoV-2 infection in high-risk patients. High-risk is ...
Eligibility Criteria
Inclusion
- PCR confirmed SARS-CoV-2 infection in a respiratory tract sample.
- Oxygen saturation (SaO2) of 94% or less while breathing ambient air or a ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of less than 300 mm Hg.
- High risk due to either pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less (group 1) and/or chronic immunosuppression not meeting the criteria of group 1 (group 2) and/or Age ≥ 50 -75 years meeting neither the criteria of group 1 nor group 2 (group 3) and at least one of these criteria: Lymphopenia \< 0.8 x G/l and/or D-dimer \> 1μg/mL and/or Age ≥ 75 years meeting neither the criteria of group 1 nor group 2 (group 4).
- Blood hemoglobin concentration ≥ 8 g/dl.
- Provision of written informed consent.
- Patient is able to understand and comply with the protocol for the duration of the study, including treatment and scheduled visits and examinations.
- Male or female patient aged ≥ 18 years
- Postmenopausal or evidence of non-childbearing status. For women of childbearing potential: negative urine or serum pregnancy test within 14 days prior to study treatment.
Exclusion
- Dementia, psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principle investigator, would affect subject safety and/or compliance.
- Contraindication to transfusion or history of prior reactions to transfusion blood products.
- Patients with selective IgA deficiency.
- Patients with mechanical ventilation and/or extracoporal membrane oxygenation (ECMO) at time of initial inclusion into the trial. Mechanical ventilation is defined as either NIV - non-invasive ventilation or positive pressure ventilation. Enrollment into another clinical trial evaluating specific therapies for COVID-19 is encouraged.
- Participation in another trial with an investigational medicinal product.
- Treatment with SARS-CoV-2 convalescent/vaccine-boosted plasma in the past.
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT05200754
Start Date
September 3 2020
End Date
June 1 2022
Last Update
February 7 2022
Active Locations (16)
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1
Charité Universtitätsmedizin Berlin
Berlin, Germany, 13353
2
Klinikum Bremen-Mitte - Klinik für Innere Medizin I
Bremen, Germany, 28205
3
Klinikum Chemnitz Medizinische Klinik III
Chemnitz, Germany, 09116
4
Klinikum Darmstadt Medizinische Klinik II
Darmstadt, Germany, 64283