Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19
RECOVER
A Randomized Open Label Phase-II Clinical Trial With or Without Infusion of Plasma From Subjects After Convalescence of SARS-CoV-2 Infection in High-Risk Patients With Confirmed Severe SARS-CoV-2 Disease
1 other identifier
interventional
174
1 country
16
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 with anti-SARS-CoV-2 convalescent/vaccine-boosted plasma or standard of care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2020
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 3, 2020
CompletedFirst Submitted
Initial submission to the registry
January 20, 2022
CompletedFirst Posted
Study publicly available on registry
January 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedFebruary 7, 2022
January 1, 2022
1.6 years
January 20, 2022
January 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Overall survival rate
within 84 days
Viral clearance
within 84 days
Cytokine profiles
within 84 days
Antibody titres
within 84 days
Requirement of mechanical ventilation
within 84 days
- +1 more secondary outcomes
Study Arms (2)
Convalescent/Vaccine-boosted Plasma
EXPERIMENTALInfusion of plasma on day 1 and 2 (238 - 337 ml anti-SARS-Cov-2 CP/PVP each)
Standard of Care
NO INTERVENTIONNo intervention - standard therapy
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Participation in another trial with an investigational medicinal product.
- Treatment with SARS-CoV-2 convalescent/vaccine-boosted plasma in the past.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Charité Universtitätsmedizin Berlin
Berlin, 13353, Germany
Klinikum Bremen-Mitte - Klinik für Innere Medizin I
Bremen, 28205, Germany
Klinikum Chemnitz Medizinische Klinik III
Chemnitz, 09116, Germany
Klinikum Darmstadt Medizinische Klinik II
Darmstadt, 64283, Germany
Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I
Dresden, 01307, Germany
Universitätsklinikum Essen Klinik für Infektiologie
Essen, 45147, Germany
Klinikum Frankfurt (Oder) - Medizinische Klinik I
Frankfurt (Oder), 15236, Germany
Universitätsklinikum Frankfurt Medizinische Klinik II
Frankfurt am Main, 60590, Germany
Universitätsklinikum Freiburg, Allgemeine Infektion-Ambulanz / Klinik für Innere Medizin II
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin I
Hamburg, 20246, Germany
Universitätsklinikum Heidelberg Innere Medizin V
Heidelberg, 69120, Germany
Thoraxklinik Heidelberg - Studienzentrum Pneumologie
Heidelberg, 69126, Germany
Klinikum Herford
Herford, 32049, Germany
Klinikum Leverkusen - Medizinische Klinik 3
Leverkusen, 51375, Germany
Klinikum Hochsauerland
Meschede, 59872, Germany
Universitätsklinikum Münster Medizinische Klinik B
Münster, 48149, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carsten Mueller-Tidow, Prof. Dr.
University Hospital Heidelberg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
January 20, 2022
First Posted
January 21, 2022
Study Start
September 3, 2020
Primary Completion
April 1, 2022
Study Completion
June 1, 2022
Last Updated
February 7, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share