Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19
NCT ID: NCT05200754
Last Updated: 2022-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
174 participants
INTERVENTIONAL
2020-09-03
2022-06-30
Brief Summary
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Detailed Description
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High-risk is defined as SARS-CoV-2 positive infection with Oxygen saturation at ≤ 94% at ambient air with additional risk features as categorized in 4 groups:
* group 1, pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less.
* group 2, chronic immunosuppression not meeting the criteria of group 1
* group 3, age ≥ 50 - 75 years meeting neither the criteria of group 1 nor group 2 and at least one of these criteria: Lymphopenia \< 0.8 x G/l and/or D-dimer \> 1μg/mL
* group 4, age ≥ 75 years meeting neither the criteria of group 1 nor group 2
The duration of the trial for each patient is expected to be about 3 months, including two days of intervention (infusion of CP/PVP), followed by a follow-up of 3 months. Furthermore viral load is measured in nasopharagyngeal swabs at day 1, 3, 5, 10, 14, 28 or until hospital discharge within 84 days after randomization. Treatment response is assessed daily until day 28, thereafter weekly until day 56, and finally at day 84.
Patients randomized into the standard arm of the study have the possibility to cross over into the experimental arm of the study starting at day 10 (+ 2 days) in case of not improving or worsening clinical condition.
In total 174 patients are planned to be enrolled in the study.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Convalescent/Vaccine-boosted Plasma
Infusion of plasma on day 1 and 2 (238 - 337 ml anti-SARS-Cov-2 CP/PVP each)
Convalescent/Vaccine-boosted Plasma (CP/PVP)
Plasma from apheresis obtained from donors, who have recovered from SARS-CoV-2 infection or received a successful vaccination against SARS-CoV-2.
CP/PVP infusion is administered on two following days. Each CP/PVP bag contains approx. 238 - 337 ml anti-SARS-Cov-2 CP/PVP for infusion.
Standard of Care
No intervention - standard therapy
No interventions assigned to this group
Interventions
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Convalescent/Vaccine-boosted Plasma (CP/PVP)
Plasma from apheresis obtained from donors, who have recovered from SARS-CoV-2 infection or received a successful vaccination against SARS-CoV-2.
CP/PVP infusion is administered on two following days. Each CP/PVP bag contains approx. 238 - 337 ml anti-SARS-Cov-2 CP/PVP for infusion.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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).
4. Blood hemoglobin concentration ≥ 8 g/dl.
5. Provision of written informed consent.
6. Patient is able to understand and comply with the protocol for the duration of the study, including treatment and scheduled visits and examinations.
7. Male or female patient aged ≥ 18 years
8. 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 Criteria
2. Contraindication to transfusion or history of prior reactions to transfusion blood products.
3. Patients with selective IgA deficiency.
4. 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.
5. Participation in another trial with an investigational medicinal product.
6. Treatment with SARS-CoV-2 convalescent/vaccine-boosted plasma in the past.
18 Years
ALL
No
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
Institut für Klinische Transfusionsmedizin und Zelltherapie Heidelberg gGmbH
UNKNOWN
Carsten Müller-Tidow
OTHER
Responsible Party
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Carsten Müller-Tidow
Medical Director
Principal Investigators
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Carsten Mueller-Tidow, Prof. Dr.
Role: STUDY_DIRECTOR
University Hospital Heidelberg
Locations
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Charité Universtitätsmedizin Berlin
Berlin, , Germany
Klinikum Bremen-Mitte - Klinik für Innere Medizin I
Bremen, , Germany
Klinikum Chemnitz Medizinische Klinik III
Chemnitz, , Germany
Klinikum Darmstadt Medizinische Klinik II
Darmstadt, , Germany
Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I
Dresden, , Germany
Universitätsklinikum Essen Klinik für Infektiologie
Essen, , Germany
Klinikum Frankfurt (Oder) - Medizinische Klinik I
Frankfurt (Oder), , Germany
Universitätsklinikum Frankfurt Medizinische Klinik II
Frankfurt am Main, , Germany
Universitätsklinikum Freiburg, Allgemeine Infektion-Ambulanz / Klinik für Innere Medizin II
Freiburg im Breisgau, , Germany
Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin I
Hamburg, , Germany
Universitätsklinikum Heidelberg Innere Medizin V
Heidelberg, , Germany
Thoraxklinik Heidelberg - Studienzentrum Pneumologie
Heidelberg, , Germany
Klinikum Herford
Herford, , Germany
Klinikum Leverkusen - Medizinische Klinik 3
Leverkusen, , Germany
Klinikum Hochsauerland
Meschede, , Germany
Universitätsklinikum Münster Medizinische Klinik B
Münster, , Germany
Countries
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Central Contacts
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Facility Contacts
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Lars Bullinger, Prof. Dr.
Role: primary
Bernd Hertenstein, Prof. Dr.
Role: primary
Mathias Hänel, PD Dr.
Role: primary
Carl Schimanski, Prof. Dr.
Role: primary
Nael Alakel, Dr. med.
Role: primary
Oliver Witzke, Prof. Dr.
Role: primary
Olaf Hopfer, Dr. med.
Role: primary
Timo Wolf, PD Dr.
Role: primary
Winfried Kern, Prof. Dr.
Role: primary
Stefan Schmiedel, Dr. med.
Role: primary
Felix Herth, Prof. Dr.
Role: primary
Matthias Ruhe, Dr. med.
Role: primary
Utz Krug, Prof. Dr.
Role: primary
Mohammad- Amen Wattad, Dr. med.
Role: primary
Phil-Robin Tepasse, Dr. med.
Role: primary
Other Identifiers
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SARS-CoV-2CP-HD-001
Identifier Type: -
Identifier Source: org_study_id
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