COVID-19Phase 2CAPSIDNCT04433910

A Clinical Trial of Convalescent Plasma Compared to Best Supportive Care for Treatment of Patients With Severe COVID-19

A Phase 2 study testing Convalesscent Plasma in people with COVID-19, run by Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen at 16 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a randomized, prospective, multicenter, open label clinical trial of convalescent plasma compared to best supportive care for treatment of patients with severe COVID-19. The aim of the study is to explore the therapeutic effect of convalescent plasma transfusions on the survival and course of disease of… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: COVID-19
What is being tested?: Convalesscent Plasma
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 16 sitesGermany
Study dates: 30 Aug 2020to 25 Mar 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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with SARS-CoV-2 infection and
age ≥ 18 years and ≤ 75 years
SARS-CoV-2 infection confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap)
severe disease defined by at least one of the following:
respiratory rate ≥ 30 breaths / minute under ambient air
requirement of any type of ventilation support
needs ICU treatment
Written informed consent by patient or legally authorized representative

Who cannot join

Accompanying diseases other than COVID-19 with an expected survival time of less than 12 months.
Previous treatment with any SARS-CoV-2-convalescent plasma
In the opinion of the clinical team, progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatment
Interval > 72 hours since start of ventilation support
Not considered eligible for extracorporeal oxygenation support (even in case of severe ARDS according to Berlin classification with Horovitz-Index < 100 mg Hg)
Chronic obstructive lung disease (COPD), stage 4

Show all 17Show fewer

Lung fibrosis with UIP pattern in CT und severe emphysema
Chronic heart failure NYHA >= 3 and/or pre-existing reduction of left ventricular ejection fraction to ≤ 30%
Shock of any type requiring ≥ 0.5 µg/kg/min noradrenaline (or equivalent) or requiring more than two types of vasopressor medication for more than 8 hours
Liver cirrhosis Child C
Liver failure: Bilirubin > 5xULN and elevation of ALT /AST (at least one >10xULN).
Any history of adverse reactions to plasma proteins
Known deficiency of immunoglobulin A
Pregnancy
Breastfeeding women
Volume overload until sufficiently treated
Participation in another clinical trial with an investigational medicinal product

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Germany16 sites

University Hospital Berlin, Charite
Berlin, 13353
Universitiy Hospital Dresden
Dresden, 01307
University Düsseldorf
Düsseldorf, 40225
University Hopsital Frankfurt
Frankfurt, Hessia, 60590
University Hospital Freiburg
Freiburg im Breisgau, 79110
University Hospital Gießen
Giessen, 35392
University Hopsital Greifswald
Greifswald, 17487
Saarland University Hospital
Homburg, Saarland, 66421
Städtisches Klinikum Karslruhe
Karlsruhe, 76133
Universtity Hospital Schleswig-Holstein
Kiel, 24105
Universtity Hospital Schleswig-Holstein
Lübeck, 23538
University Hospital Mannheim
Mannheim, 68167
University Hospital Marburg
Marburg, 35033
Klinikum Stuttgart
Stuttgart, 70174
University Hospital Tübingen
Tübingen, 72076
University Hospital Ulm
Ulm, Baden-Württmberg, 89081

Other trials in Germany

About this study

Official title: A Randomized, Prospective, Open Label Clinical Trial on the Use of Convalescent Plasma Compared to Best Supportive Care in Patients With Severe COVID-19

This is a randomized, prospective, multicenter, open label clinical trial of convalescent plasma compared to best supportive care for treatment of patients with severe COVID-19.

The aim of the study is to explore the therapeutic effect of convalescent plasma transfusions on the survival and course of disease of patients with severe COVID-19. Convalescent plasma will be collected from recovered COVID-19 patients.

Patients with severe COVID-19 will be randomly assigned to two groups. Patients in the treatment group will receive covalescent plasma (250 - 325 ml) on days 1, 3 and 5. Patients in the control group will receive best supportive care. Clinical condition in all patients will be evaluated on day 14. In case of progressive COVID-19 on day 14 compared to baseline, patients in the control group may be switched to treatment with convalescent plasma on days 15, 17 and 19.

Fifty-three patients will be included in each group. Data of each patient will be collected until discharge but nor longer than day 60.

Read the detailed description

This is a randomized, prospective, multicentre, open label clinical trial of convalescent plasma compared to best supportive care for treatment of patients with severe COVID-19.

The primary Endpoint is a dichotomous composite endpoint of survival and no longer fulfilling criteria of severe COVID-19 within 21 days after randomization. All criteria must be met in order to fulfil the primary endpoint.

Key secondary endpoints are time to clinical improvement (defined as time from randomization to an improvement of two points on the WHO R\&D Blueprint seven-category ordinal scale for clinical improvement), the frequency and severity of adverse events and the case fatality rate on day 21, 35 and 60. Further secondary endpoints refer to the course of anti-SARS-CoV-2 antibodies in plasma donors and treated patients and the impact of donor criteria on the effectiveness of plasma units.

Patients with severe COVID-19 defined by a respiratory rate ≥ 30 breaths / minute under ambient air or the requirement of any type of ventilation support or the need for ICU treatment can be included in the trial. It is planned to enrol 106 patients. Patients will be stratified according to ventilation support and/or extracorporeal oxygenation and/or ICU treatment and will be equally asigned to two groups. The treatment group receives convalescent plasma (250 - 325 ml) on day 1, 3 and 5 and the control group will receive best supportive care. Clinical condition in all patients will be evaluated on day 14. In case of progressive COVID-19 on day 14 compared to baseline (i.e. day 0), patients in the control group may be switched to treatment with convalescent plasma on days 15, 17 and 19. A patient switching from the control group to convalescent plasma group because of progressive COVID-19 on day 14 will be considered as failure of the primary endpoint at final evaluation of the primary endpoint on day 21.

Conditions: COVID-19
Being tested: Convalesscent Plasma
Keywords: convalescent plasma
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Convalesscent PlasmaDrug
Transfusion

Study groups in NCT04433910
Study group	Role	What they receive
Convalescent plasma	Experimental	Convalescent plasma transfusion on day 1, 3 and 5. Receives: Drug: Convalesscent Plasma
Best supportive care	No intervention	Best supportive care, cross over for patients with progressive disease on day 14 with convalescent plasma transfusion on day 15, 17 and 19.

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite endpoint of survival and no longer fulfilling criteria of severe COVID-19.
Dichotomous composite endpoint of survival and no longer fulfilling criteria of severe COVID-19. All criteria must be met in order to fulfil the primary endpoint.
Measured: Day 21

Secondary outcomes (31)

Time to clinical improvement
Time to clinical improvement (defined as days from randomization to an improvement of two points on the WHO R\&D Blueprint seven-category ordinal scale for clinical improvement) (Key secondary endpoint)
Measured: day 0 to discharge within a 60 day period
Frequency and severity of adverse events by CTCAE v5.0, (Key secondary endpoint)
Measured: day 0 to discharge within a 60 day period
Case fatality rate
Measured: on day 21, 35 and 60
Length of hospital stay Length of hospital stay (if applicable)
Measured: day 0 to 60
Length of stay in ICU
Measured: day 0 to 60
Duration of ventilation support / ECMO
Measured: day 0 to 60
Time until negative SARS-CoV-2 PCR (nasopharyngeal sample)
time to first negative PCR will be assessed
Measured: day 0 to 60
Predictive value of comorbidities
Comorbidities will be assessed and correlated to clinical improvement (WHO scale), mortality, length of stay in ICU (days) and length of hospital stay (days)
Measured: day 0 to 60
Predictive value of coagulation markers
Correlation of coagulation markers (D-Dimers, prothrombin time, Partial Thromboplastin Time, ATIII, Fibrinogen) with clinical improvement (WHO scale), mortality, length of stay in ICU (days) and length of hospital stay (days)
Measured: day 0 to 60
Predictive value of inflamation
Corelation of Inflammation (laboratory testing: CRP, IL-6, Ferritin, Blood cell Count) with clinical improvement (WHO scale), mortality, length of stay in ICU (days) and length of hospital stay (days)
Measured: day 0 to 60
Percentage of former COVID-19 patients willing to donate qualifying for plasma donation.
Measured: through study completion, an average of 8 months
Amount of Plasma Units that could be collected for the clinical trial
Measured: through study completion, an average of 8 months
Titer of anti-SARS-CoV-2 in transfused plasma units
Measured: any plasmaphereseis, through study completion, an average of 8 months
Impact of donor characteristics on anti-SARS-CoV-2 humoral response
Anti-SARS-CoV-2-antibody titers will be correlated with age; gender; severity of COVID-19; interval between resolution of symptoms and plasmapheresis of plasma donors
Measured: up to 60 days
Course of anti-SARS-CoV-2 titer in both patient groups at different time points related to transfusion of convalescent plasma
Neutralizing anti-SARS-CoV-2 titers were measured by PRNT
Measured: up to 60 days
Correlation of anti-SARS-CoV-2 titer in transfused plasma units and primary and key secondary outcomes.
Correlation of antibody titers with: 1. "Survival and no longer fulfilling criteria of severe COVID-19"; 2. Change in WHO ordinal scale; 3. Time to clinical improvement; 4. Length of hospital stay; 5. Length of ICU stay; 6. Length of mechanical Ventilation or ECMO support.
Measured: day 0 to 60
Effect of timing of plasma transfusions
Effect of timing of plasma transfusions on outcome: comparison of early treatment, i.e. day 1, 3 and 5 in convalescent plasma group vs. delayed treatment, i.e. day 15, 17, 19 in patients crossing over from control group due to progressive disease on day-14 assessment.
Measured: day 0 to 60
Long term survival
Long term survival up to 15 months after randomisation (patients in CCP group* compared to control group) or first plasma donation (CCP donors). And high-titer group versus low -titer group versus control.
Measured: 15 month
Frequency of long COVID-19
Frequency of long COVID-19* up to 15 months after randomisation (patients in CCP group* compared to control group) or first plasma donation (CCP donors).And high-titer group versus low -titer group versus control.
Measured: 15 month
Resolution of pneumonia and functional recovery
Resolution of pneumonia and functional recovery* in patients (CCP group compared to control group and donors). Assessment will be done by CTCAE 5.0 and structured interview. And high-titer group versus low -titer group versus control.
Measured: 15 month
Patient Reported Outcome: FACIT Fatigue Score
FACIT Fatigue Score: 0-53 : The higher the score, the better the quality of life Comparisons between patients CCP group compared to control group and donors and high-titer group versus low -titer group versus control group.
Measured: 15 month
Patient Reported Outcome: FACIT Dyspnea Score
FACIT Dyspnea Score 1 and 2: 0-30 : The lhigher the score the worse is the dypnea Comparisons between patients CCP group compared to control group and donors and high-titer group versus low -titer group versus control group.
Measured: 15 month
Patient Reported Outcome: EQ-5D-5L visual Scale
EQ-5D-5L visual scale: 0-100, The lower the socre, the worse is the health state Comparisons between patients CCP group compared to control group and donors and high-titer group versus low -titer group versus control group.
Measured: 15 month
Patient Reported Outcome:EQ-5D-5L cross walk
EQ-5D-5L cross walk score: 0-1.0 The lower the socre, the worse is the health state Comparisons between patients CCP group compared to control group and donors and high-titer group versus low -titer group versus control group.
Measured: 15 month
Laboratory markers: D-Dimers
D-Dimers will be correlated with the Levels of SARS-CoV-2 antodies as a measure of anti-SARS-CoV-2 immunity and compared between the patient groups (in patients: CCP group compared to control group and donors). The effect of SARS-CoV-2 vaccination* in control group, CCP group and CCP donors will also be taken into account.Measures will also be compeared between high-titer group versus low -titer group versus control group.
Measured: 15 month
Laboratory markers: Fibrinogen
Fibronogen will be correlated with the Levels of SARS-CoV-2 antodies as a measure of anti-SARS-CoV-2 immunity and compared between the patient groups (in patients: CCP group compared to control group and donors). The effect of SARS-CoV-2 vaccination* in control group, CCP group and CCP donors will also be taken into account.Measures will also be compeared between high-titer group versus low -titer group versus control group.
Measured: 15 month
Laboratory markers: CRP
CRP will be correlated with the Levels of SARS-CoV-2 antodies as a measure of anti-SARS-CoV-2 immunity and compared between the patient groups (in patients: CCP group compared to control group and donors). The effect of SARS-CoV-2 vaccination* in control group, CCP group and CCP donors will also be taken into account.Measures will also be compeared between high-titer group versus low -titer group versus control group.
Measured: 15 month
Laboratory markers: Ferritin
Ferritin will be correlated with the Levels of SARS-CoV-2 antodies as a measure of anti-SARS-CoV-2 immunity and compared between the patient groups (in patients: CCP group compared to control group and donors). The effect of SARS-CoV-2 vaccination* in control group, CCP group and CCP donors will also be taken into account.Measures will also be compeared between high-titer group versus low -titer group versus control group.
Measured: 15 month
Laboratory markers: IL-6
IL-6 will be correlated with the Levels of SARS-CoV-2 antodies as a measure of anti-SARS-CoV-2 immunity and compared between the patient groups (in patients: CCP group compared to control group and donors). The effect of SARS-CoV-2 vaccination* in control group, CCP group and CCP donors will also be taken into account.Measures will also be compeared between high-titer group versus low -titer group versus control group.
Measured: 15 month
Severity of long COVID-19
Severity of long COVID-19* up to 15 months after randomisation (patients in CCP group* compared to control group) or first plasma donation (CCP donors). Grading according Post-COVID-19 Scale from 0 (no functional limitations) to 4 (severe functional limitations). Measures will also be compeared between high-titer group versus low -titer group versus control group.
Measured: 15 month
Duration of long COVID-19
Duration of long COVID-19* up to 15 months after randomisation (patients in CCP group* compared to control group) or first plasma donation (CCP donors). Measures will also be compeared between high-titer group versus low -titer group versus control group.
Measured: 15 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 202025 Mar 2022

First posted16 Jun 2020
Study start30 Aug 2020
Primary completion21 Jan 2021
Study completion25 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04433910
Sponsor's protocol ID: CAPSID2020-DRK-BSD
Other IDs: 2020-001310-38
Acronym: CAPSID
Status last verified: Sep 2023
First submitted: 6 May 2020
Last updated: 14 Sep 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.
PubMed 37162745
Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.
PubMed 36734509
Korper S, Gruner B, Zickler D, Wiesmann T, Wuchter P, Blasczyk R, Zacharowski K, Spieth P, Tonn T, Rosenberger P, Paul G, Pilch J, Schwable J, Bakchoul T, Thiele T, Knorlein J, Dollinger MM, Krebs J, Bentz M, Corman VM, Kilalic D, Schmidtke-Schrezenmeier G, Lepper PM, Ernst L, Wulf H, Ulrich A, Weiss M, Kruse JM, Burkhardt T, Muller R, Kluter H, Schmidt M, Jahrsdorfer B, Lotfi R, Rojewski M, Appl T, Mayer B, Schnecko P, Seifried E, Schrezenmeier H. One-year follow-up of the CAPSID randomized trial for high-dose convalescent plasma in severe COVID-19 patients. J Clin Invest. 2022 Dec 15;132(24):e163657. doi: 10.1172/JCI163657.
PubMed 36326824
Korper S, Schrezenmeier EV, Rincon-Arevalo H, Gruner B, Zickler D, Weiss M, Wiesmann T, Zacharowski K, Kalbhenn J, Bentz M, Dollinger MM, Paul G, Lepper PM, Ernst L, Wulf H, Zinn S, Appl T, Jahrsdorfer B, Rojewski M, Lotfi R, Dorner T, Jungwirth B, Seifried E, Furst D, Schrezenmeier H. Cytokine levels associated with favorable clinical outcome in the CAPSID randomized trial of convalescent plasma in patients with severe COVID-19. Front Immunol. 2022 Oct 6;13:1008438. doi: 10.3389/fimmu.2022.1008438. eCollection 2022.
PubMed 36275695
Korper S, Weiss M, Zickler D, Wiesmann T, Zacharowski K, Corman VM, Gruner B, Ernst L, Spieth P, Lepper PM, Bentz M, Zinn S, Paul G, Kalbhenn J, Dollinger MM, Rosenberger P, Kirschning T, Thiele T, Appl T, Mayer B, Schmidt M, Drosten C, Wulf H, Kruse JM, Jungwirth B, Seifried E, Schrezenmeier H; CAPSID Clinical Trial Group. Results of the CAPSID randomized trial for high-dose convalescent plasma in patients with severe COVID-19. J Clin Invest. 2021 Oct 15;131(20):e152264. doi: 10.1172/JCI152264.
PubMed 34464358
Conzelmann C, Gilg A, Gross R, Schutz D, Preising N, Standker L, Jahrsdorfer B, Schrezenmeier H, Sparrer KMJ, Stamminger T, Stenger S, Munch J, Muller JA. An enzyme-based immunodetection assay to quantify SARS-CoV-2 infection. Antiviral Res. 2020 Sep;181:104882. doi: 10.1016/j.antiviral.2020.104882. Epub 2020 Jul 29.
PubMed 32738255

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Prospective, Open Label Clinical Trial on the Use of Convalescent Plasma Compared to Best Supportive Care in Patients With Severe COVID-19
ClinicalTrials.gov ID: NCT04433910
Acronym / sponsor ID: CAPSID / CAPSID2020-DRK-BSD
Conditions: COVID-19
Keywords: convalescent plasma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-HessenUniversity, hospital or other
Study start: 30 Aug 2020 (actual)
Primary completion: 21 Jan 2021 (actual)
Study completion: 25 Mar 2022 (actual)
First posted: 16 Jun 2020 (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.

This is a randomized, prospective, multicenter, open label clinical trial of convalescent plasma compared to best supportive care for treatment of patients with severe COVID-19.

Fifty-three patients will be included in each group. Data of each patient will be collected until discharge but nor longer than day 60.

Detailed description

This is a randomized, prospective, multicentre, open label clinical trial of convalescent plasma compared to best supportive care for treatment of patients with severe COVID-19.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Convalescent plasma	Experimental	Drug: Convalesscent PlasmaConvalescent plasma transfusion on day 1, 3 and 5.
Best supportive care	No intervention	–Best supportive care, cross over for patients with progressive disease on day 14 with convalescent plasma transfusion on day 15, 17 and 19.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients with SARS-CoV-2 infection and
age ≥ 18 years and ≤ 75 years
SARS-CoV-2 infection confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap)
severe disease defined by at least one of the following:
Written informed consent by patient or legally authorized representative

Key exclusion criteria (17 listed)

Accompanying diseases other than COVID-19 with an expected survival time of less than 12 months.
Previous treatment with any SARS-CoV-2-convalescent plasma
In the opinion of the clinical team, progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatment
Interval > 72 hours since start of ventilation support
Not considered eligible for extracorporeal oxygenation support (even in case of severe ARDS according to Berlin classification with Horovitz-Index < 100 mg Hg)

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
Convalesscent PlasmaTransfusion	Drug	Convalescent plasma

Primary outcome

Composite endpoint of survival and no longer fulfilling criteria of severe COVID-19.
Time frame: Day 21
Dichotomous composite endpoint of survival and no longer fulfilling criteria of severe COVID-19. All criteria must be met in order to fulfil the primary endpoint.

31 secondary outcomes

Time to clinical improvement
Time frame: day 0 to discharge within a 60 day period
Frequency and severity of adverse events by CTCAE v5.0, (Key secondary endpoint)
Time frame: day 0 to discharge within a 60 day period
Case fatality rate
Time frame: on day 21, 35 and 60
Length of hospital stay Length of hospital stay (if applicable)
Time frame: day 0 to 60
Length of stay in ICU
Time frame: day 0 to 60
Duration of ventilation support / ECMO
Time frame: day 0 to 60
Time until negative SARS-CoV-2 PCR (nasopharyngeal sample)
Time frame: day 0 to 60
Predictive value of comorbidities
Time frame: day 0 to 60
Predictive value of coagulation markers
Time frame: day 0 to 60
Predictive value of inflamation
Time frame: day 0 to 60
Percentage of former COVID-19 patients willing to donate qualifying for plasma donation.
Time frame: through study completion, an average of 8 months
Amount of Plasma Units that could be collected for the clinical trial
Time frame: through study completion, an average of 8 months
Titer of anti-SARS-CoV-2 in transfused plasma units
Time frame: any plasmaphereseis, through study completion, an average of 8 months
Impact of donor characteristics on anti-SARS-CoV-2 humoral response
Time frame: up to 60 days
Course of anti-SARS-CoV-2 titer in both patient groups at different time points related to transfusion of convalescent plasma
Time frame: up to 60 days
Correlation of anti-SARS-CoV-2 titer in transfused plasma units and primary and key secondary outcomes.
Time frame: day 0 to 60
Effect of timing of plasma transfusions
Time frame: day 0 to 60
Long term survival
Time frame: 15 month
Frequency of long COVID-19
Time frame: 15 month
Resolution of pneumonia and functional recovery
Time frame: 15 month
Patient Reported Outcome: FACIT Fatigue Score
Time frame: 15 month
Patient Reported Outcome: FACIT Dyspnea Score
Time frame: 15 month
Patient Reported Outcome: EQ-5D-5L visual Scale
Time frame: 15 month
Patient Reported Outcome:EQ-5D-5L cross walk
Time frame: 15 month
Laboratory markers: D-Dimers
Time frame: 15 month
Laboratory markers: Fibrinogen
Time frame: 15 month
Laboratory markers: CRP
Time frame: 15 month
Laboratory markers: Ferritin
Time frame: 15 month
Laboratory markers: IL-6
Time frame: 15 month
Severity of long COVID-19
Time frame: 15 month
Duration of long COVID-19
Time frame: 15 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
Derived from this study: PubMed 37162745Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.
Derived from this study: PubMed 36734509Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.
Derived from this study: PubMed 36326824Korper S, Gruner B, Zickler D, Wiesmann T, Wuchter P, Blasczyk R, Zacharowski K, Spieth P, Tonn T, Rosenberger P, Paul G, Pilch J, Schwable J, Bakchoul T, Thiele T, Knorlein J, Dollinger MM, Krebs J, Bentz M, Corman VM, Kilalic D, Schmidtke-Schrezenmeier G, Lepper PM, Ernst L, Wulf H, Ulrich A, Weiss M, Kruse JM, Burkhardt T, Muller R, Kluter H, Schmidt M, Jahrsdorfer B, Lotfi R, Rojewski M, Appl T, Mayer B, Schnecko P, Seifried E, Schrezenmeier H. One-year follow-up of the CAPSID randomized trial for high-dose convalescent plasma in severe COVID-19 patients. J Clin Invest. 2022 Dec 15;132(24):e163657. doi: 10.1172/JCI163657.
Derived from this study: PubMed 36275695Korper S, Schrezenmeier EV, Rincon-Arevalo H, Gruner B, Zickler D, Weiss M, Wiesmann T, Zacharowski K, Kalbhenn J, Bentz M, Dollinger MM, Paul G, Lepper PM, Ernst L, Wulf H, Zinn S, Appl T, Jahrsdorfer B, Rojewski M, Lotfi R, Dorner T, Jungwirth B, Seifried E, Furst D, Schrezenmeier H. Cytokine levels associated with favorable clinical outcome in the CAPSID randomized trial of convalescent plasma in patients with severe COVID-19. Front Immunol. 2022 Oct 6;13:1008438. doi: 10.3389/fimmu.2022.1008438. eCollection 2022.
Derived from this study: PubMed 34464358Korper S, Weiss M, Zickler D, Wiesmann T, Zacharowski K, Corman VM, Gruner B, Ernst L, Spieth P, Lepper PM, Bentz M, Zinn S, Paul G, Kalbhenn J, Dollinger MM, Rosenberger P, Kirschning T, Thiele T, Appl T, Mayer B, Schmidt M, Drosten C, Wulf H, Kruse JM, Jungwirth B, Seifried E, Schrezenmeier H; CAPSID Clinical Trial Group. Results of the CAPSID randomized trial for high-dose convalescent plasma in patients with severe COVID-19. J Clin Invest. 2021 Oct 15;131(20):e152264. doi: 10.1172/JCI152264.
Derived from this study: PubMed 32738255Conzelmann C, Gilg A, Gross R, Schutz D, Preising N, Standker L, Jahrsdorfer B, Schrezenmeier H, Sparrer KMJ, Stamminger T, Stenger S, Munch J, Muller JA. An enzyme-based immunodetection assay to quantify SARS-CoV-2 infection. Antiviral Res. 2020 Sep;181:104882. doi: 10.1016/j.antiviral.2020.104882. Epub 2020 Jul 29.
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.

Hubert Schrezenmeier, Prof.Dr. principal investigator

IKT Ulm

Erhard Seifried, Prof.Dr.Dr. study director

German Red Cross Blood Service

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 Convalesscent Plasma in people with COVID-19, run by Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen 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 17 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: finished, as of the sponsor's last update on 14 Sep 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite endpoint of survival and no longer fulfilling criteria of severe COVID-19. (time frame: Day 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04433910, which also lists 6 linked publications.

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 14 Sep 2023.