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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05200754
Other study ID # SARS-CoV-2CP-HD-001
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 3, 2020
Est. completion date June 2022

Study information

Verified date January 2022
Source University Hospital Heidelberg
Contact Carsten Mueller-Tidow, Prof. Dr.
Phone +49 6221-56 8001
Email carsten.mueller-tidow@med.uni-heidelberg.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 with anti-SARS-CoV-2 convalescent/vaccine-boosted plasma or standard of care.


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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 174
Est. completion date June 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. PCR confirmed SARS-CoV-2 infection in a respiratory tract sample. 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: 1. 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. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Germany 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 Universitätsklinikum Frankfurt Medizinische Klinik II Frankfurt am Main
Germany Klinikum Frankfurt (Oder) - Medizinische Klinik I Frankfurt/Oder
Germany Universitätsklinikum Freiburg, Allgemeine Infektion-Ambulanz / Klinik für Innere Medizin II Freiburg
Germany Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin I Hamburg
Germany Thoraxklinik Heidelberg - Studienzentrum Pneumologie Heidelberg
Germany Universitätsklinikum Heidelberg Innere Medizin V Heidelberg
Germany Klinikum Herford Herford
Germany Klinikum Leverkusen - Medizinische Klinik 3 Leverkusen
Germany Klinikum Hochsauerland Meschede
Germany Universitätsklinikum Münster Medizinische Klinik B Münster

Sponsors (3)

Lead Sponsor Collaborator
Carsten Müller-Tidow German Federal Ministry of Education and Research, Institut für Klinische Transfusionsmedizin und Zelltherapie Heidelberg gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Improvement Time from randomization until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital within 84 days
Secondary Overall survival rate Overall survival and overall survival rate at 28, 56 and 84 days within 84 days
Secondary Viral clearance SARS-CoV-2 viral clearance and load within 84 days
Secondary Cytokine profiles Cytokine changes over time within 84 days
Secondary Antibody titres Measurement of antiviral antibody titres within 84 days
Secondary Requirement of mechanical ventilation Percentage of patients that required mechanical ventilation within 84 days
Secondary Discharge from hospital Time from randomization until discharge within 84 days
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