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Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19 (RECOVER)

Primary Purpose

SARS-CoV-2 Infection

Status

Recruiting

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Convalescent/Vaccine-boosted Plasma (CP/PVP)

About this trial

This is an interventional treatment trial for SARS-CoV-2 Infection focused on measuring High risk patients, convalescent plasma, post vaccination plasma, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Charité Universtitätsmedizin BerlinRecruiting
Klinikum Bremen-Mitte - Klinik für Innere Medizin IRecruiting
Klinikum Chemnitz Medizinische Klinik IIIRecruiting
Klinikum Darmstadt Medizinische Klinik IIRecruiting
Universitätsklinikum Dresden Medizinische Klinik und Poliklinik IRecruiting
Universitätsklinikum Essen Klinik für InfektiologieRecruiting
Universitätsklinikum Frankfurt Medizinische Klinik IIRecruiting
Klinikum Frankfurt (Oder) - Medizinische Klinik IRecruiting
Universitätsklinikum Freiburg, Allgemeine Infektion-Ambulanz / Klinik für Innere Medizin IIRecruiting
Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin IRecruiting
Universitätsklinikum Heidelberg Innere Medizin VRecruiting
Thoraxklinik Heidelberg - Studienzentrum PneumologieRecruiting
Klinikum HerfordRecruiting
Klinikum Leverkusen - Medizinische Klinik 3
Klinikum HochsauerlandRecruiting
Universitätsklinikum Münster Medizinische Klinik BRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Convalescent/Vaccine-boosted Plasma

Standard of Care

Arm Description

Infusion of plasma on day 1 and 2 (238 - 337 ml anti-SARS-Cov-2 CP/PVP each)

No intervention - standard therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival rate

Overall survival and overall survival rate at 28, 56 and 84 days

Viral clearance

SARS-CoV-2 viral clearance and load

Cytokine profiles

Cytokine changes over time

Antibody titres

Measurement of antiviral antibody titres

Requirement of mechanical ventilation

Percentage of patients that required mechanical ventilation

Discharge from hospital

Time from randomization until discharge

Full Information

NCT ID

NCT05200754

First Posted

January 20, 2022

Last Updated

January 21, 2022

Sponsor

Carsten Müller-Tidow

Collaborators

German Federal Ministry of Education and Research, Institut für Klinische Transfusionsmedizin und Zelltherapie Heidelberg gGmbH

1. Study Identification

Unique Protocol Identification Number

NCT05200754

Brief Title

Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19

Acronym

RECOVER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 3, 2020 (Actual)

Primary Completion Date

April 2022 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Carsten Müller-Tidow

Collaborators

German Federal Ministry of Education and Research, Institut für Klinische Transfusionsmedizin und Zelltherapie Heidelberg gGmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV-2 Infection

Keywords

High risk patients, convalescent plasma, post vaccination plasma, COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Convalescent/Vaccine-boosted Plasma

Arm Type

Experimental

Arm Description

Infusion of plasma on day 1 and 2 (238 - 337 ml anti-SARS-Cov-2 CP/PVP each)

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

No intervention - standard therapy

Intervention Type

Other

Intervention Name(s)

Convalescent/Vaccine-boosted Plasma (CP/PVP)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Clinical Improvement

Description

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

Time Frame

within 84 days

Secondary Outcome Measure Information:

Title

Overall survival rate

Description

Overall survival and overall survival rate at 28, 56 and 84 days

Time Frame

within 84 days

Title

Viral clearance

Description

SARS-CoV-2 viral clearance and load

Time Frame

within 84 days

Title

Cytokine profiles

Description

Cytokine changes over time

Time Frame

within 84 days

Title

Antibody titres

Description

Measurement of antiviral antibody titres

Time Frame

within 84 days

Title

Requirement of mechanical ventilation

Description

Percentage of patients that required mechanical ventilation

Time Frame

within 84 days

Title

Discharge from hospital

Description

Time from randomization until discharge

Time Frame

within 84 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carsten Mueller-Tidow, Prof. Dr.

Phone

+49 6221-56 8001

carsten.mueller-tidow@med.uni-heidelberg.de

First Name & Middle Initial & Last Name or Official Title & Degree

Claudia Denkinger, PD Dr.

Phone

+49 6221- 56 22999

claudia.denkinger@med.uni-heidelberg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carsten Mueller-Tidow, Prof. Dr.

Organizational Affiliation

University Hospital Heidelberg

Official's Role

Study Director

Facility Information:

Facility Name

Charité Universtitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lars Bullinger, Prof. Dr.

Facility Name

Klinikum Bremen-Mitte - Klinik für Innere Medizin I

City

Bremen

ZIP/Postal Code

28205

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bernd Hertenstein, Prof. Dr.

Facility Name

Klinikum Chemnitz Medizinische Klinik III

City

Chemnitz

ZIP/Postal Code

09116

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathias Hänel, PD Dr.

Facility Name

Klinikum Darmstadt Medizinische Klinik II

City

Darmstadt

ZIP/Postal Code

64283

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carl Schimanski, Prof. Dr.

Facility Name

Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nael Alakel, Dr. med.

Facility Name

Universitätsklinikum Essen Klinik für Infektiologie

City

Essen

ZIP/Postal Code

45147

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oliver Witzke, Prof. Dr.

Facility Name

Universitätsklinikum Frankfurt Medizinische Klinik II

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timo Wolf, PD Dr.

Facility Name

Klinikum Frankfurt (Oder) - Medizinische Klinik I

City

Frankfurt/Oder

ZIP/Postal Code

15236

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olaf Hopfer, Dr. med.

Facility Name

Universitätsklinikum Freiburg, Allgemeine Infektion-Ambulanz / Klinik für Innere Medizin II

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Winfried Kern, Prof. Dr.

Facility Name

Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin I

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefan Schmiedel, Dr. med.

Facility Name

Universitätsklinikum Heidelberg Innere Medizin V

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carsten Mueller-Tidow, Prof. Dr.

Phone

+49 6221 56 8001

carsten.mueller-tidow@med.uni-heidelberg.de

Facility Name

Thoraxklinik Heidelberg - Studienzentrum Pneumologie

City

Heidelberg

ZIP/Postal Code

69126

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Felix Herth, Prof. Dr.

Facility Name

Klinikum Herford

City

Herford

ZIP/Postal Code

32049

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthias Ruhe, Dr. med.

Facility Name

Klinikum Leverkusen - Medizinische Klinik 3

City

Leverkusen

ZIP/Postal Code

51375

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Utz Krug, Prof. Dr.

Facility Name

Klinikum Hochsauerland

City

Meschede

ZIP/Postal Code

59872

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohammad- Amen Wattad, Dr. med.

Facility Name

Universitätsklinikum Münster Medizinische Klinik B

City

Münster

ZIP/Postal Code

48149

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Phil-Robin Tepasse, Dr. med.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19

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