SARS-CoV-2 InfectionPhase 2RECOVERNCT05200754
Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19
A Phase 2 study testing Convalescent/Vaccine-boosted Plasma (CP/PVP) in people with SARS-CoV-2 Infection, run by Carsten Müller-Tidow at 16 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- Convalescent/Vaccine-boosted Plasma (CP/PVP)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 16 sitesGermany
- Study dates
- 3 Sep 2020to Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Germany16 sites, 16 recruiting
- Recruiting
Charité Universtitätsmedizin Berlin
Berlin, 13353
Lars Bullinger, Prof. Dr.
- Recruiting
Klinikum Bremen-Mitte - Klinik für Innere Medizin I
Bremen, 28205
Bernd Hertenstein, Prof. Dr.
- Recruiting
Klinikum Chemnitz Medizinische Klinik III
Chemnitz, 09116
Mathias Hänel, PD Dr.
- Recruiting
Klinikum Darmstadt Medizinische Klinik II
Darmstadt, 64283
Carl Schimanski, Prof. Dr.
- Recruiting
Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I
Dresden, 01307
Nael Alakel, Dr. med.
- Recruiting
Universitätsklinikum Essen Klinik für Infektiologie
Essen, 45147
Oliver Witzke, Prof. Dr.
- Recruiting
Klinikum Frankfurt (Oder) - Medizinische Klinik I
Frankfurt (Oder), 15236
Olaf Hopfer, Dr. med.
- Recruiting
Universitätsklinikum Frankfurt Medizinische Klinik II
Frankfurt am Main, 60590
Timo Wolf, PD Dr.
- Recruiting
Universitätsklinikum Freiburg, Allgemeine Infektion-Ambulanz / Klinik für Innere Medizin II
Freiburg im Breisgau, 79106
Winfried Kern, Prof. Dr.
- Recruiting
Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin I
Hamburg, 20246
Stefan Schmiedel, Dr. med.
- Recruiting
Universitätsklinikum Heidelberg Innere Medizin V
Heidelberg, 69120
Carsten Mueller-Tidow, Prof. Dr., +49 6221 56 8001, carsten.mueller-tidow@med.uni-heidelberg.de
- Recruiting
Thoraxklinik Heidelberg - Studienzentrum Pneumologie
Heidelberg, 69126
Felix Herth, Prof. Dr.
- Recruiting
Klinikum Herford
Herford, 32049
Matthias Ruhe, Dr. med.
- Not yet recruiting
Klinikum Leverkusen - Medizinische Klinik 3
Leverkusen, 51375
Utz Krug, Prof. Dr.
- Recruiting
Klinikum Hochsauerland
Meschede, 59872
Mohammad- Amen Wattad, Dr. med.
- Recruiting
Universitätsklinikum Münster Medizinische Klinik B
Münster, 48149
Phil-Robin Tepasse, Dr. med.
About this study
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
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.
Read the 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.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- Convalescent/Vaccine-boosted Plasma (CP/PVP)
- Keywords
- High risk patients, convalescent plasma, post vaccination plasma, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent/Vaccine-boosted Plasma (CP/PVP)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Convalescent/Vaccine-boosted Plasma | Experimental | Infusion of plasma on day 1 and 2 (238 - 337 ml anti-SARS-Cov-2 CP/PVP each) Receives: Other: Convalescent/Vaccine-boosted Plasma (CP/PVP) |
| Standard of Care | No intervention | No intervention - standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 84 days
Secondary outcomes (6)
Overall survival rate
Overall survival and overall survival rate at 28, 56 and 84 days
Measured: within 84 days
Viral clearance
SARS-CoV-2 viral clearance and load
Measured: within 84 days
Cytokine profiles
Cytokine changes over time
Measured: within 84 days
Antibody titres
Measurement of antiviral antibody titres
Measured: within 84 days
Requirement of mechanical ventilation
Percentage of patients that required mechanical ventilation
Measured: within 84 days
Discharge from hospital
Time from randomization until discharge
Measured: within 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start3 Sep 2020
- Primary completionApr 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carsten Müller-Tidow
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Institut für Klinische Transfusionsmedizin und Zelltherapie Heidelberg gGmbH
- Responsible party
- Sponsor-investigator, Carsten Müller-Tidow, University Hospital Heidelberg
- Investigators
- Carsten Mueller-Tidow, Prof. Dr., Study director, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200754
- Sponsor's protocol ID
- SARS-CoV-2CP-HD-001
- Acronym
- RECOVER
- Status last verified
- Jan 2022
- First submitted
- 20 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05200754
- Acronym / sponsor ID
- RECOVER / SARS-CoV-2CP-HD-001
- Conditions
- SARS-CoV-2 Infection
- Keywords
- High risk patients, convalescent plasma, post vaccination plasma, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Carsten Müller-TidowUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Institut für Klinische Transfusionsmedizin und Zelltherapie Heidelberg gGmbH
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convalescent/Vaccine-boosted Plasma | Experimental | Other: Convalescent/Vaccine-boosted Plasma (CP/PVP)Infusion of plasma on day 1 and 2 (238 - 337 ml anti-SARS-Cov-2 CP/PVP each) |
| Standard of Care | No intervention | –No intervention - standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Convalescent/Vaccine-boosted Plasma |
Primary outcome
Clinical Improvement
Time frame: within 84 days
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
6 secondary outcomes
Overall survival rate
Time frame: within 84 days
Viral clearance
Time frame: within 84 days
Cytokine profiles
Time frame: within 84 days
Antibody titres
Time frame: within 84 days
Requirement of mechanical ventilation
Time frame: within 84 days
Discharge from hospital
Time frame: within 84 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Mueller-Tidow, Prof. Dr. study director
University Hospital Heidelberg
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Convalescent/Vaccine-boosted Plasma (CP/PVP) in people with SARS-CoV-2 Infection, run by Carsten Müller-Tidow at 16 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carsten Mueller-Tidow, Prof. Dr. (+49 6221-56 8001, carsten.mueller-tidow@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Improvement (time frame: within 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.