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COVID-19Phase 1CPT-ZHPNCT04869072

Convalescent Plasma Therapy - Zurich Protocol

A Phase 1 study testing Convalescent plasma in people with COVID-19, run by University of Zurich at 1 site in Switzerland.

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 an open-label, single-center, phase I study to assess the safety and efficacy of convalescent plasma therapy (CPT) obtained from donors who were tested positive for SARS-CoV-2 and fully recovered from the infection and administered to patients who are infected with the new coronavirus and present dyspnea or a… Read more about this study

Who is it for?
Any age
Conditions the study is for
COVID-19
What is being tested?
Convalescent plasma
Type of treatment
Injection or infusion
How many people
30 participants
Where
1 siteSwitzerland
Study dates
29 Apr 2020to 30 Mar 2021
Phase
Phase 1
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Proven Sars-CoV-2 by PCR and hospitalization for COVID-19 in combination with either (1) or (2):
  • Age ≥50
  • AND (at least one):
  • Pre-existing cardiovascular disease
  • Diabetic disease
  • Immunodeficiency/immunosuppression
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  • Neoplastic disease
  • COPD or chronic liver disease or chronic renal failure
  • Age ≥18
  • AND (at least one):
  • SpO2 ≤ 94% on room air or requiring supplemental oxygen at screening
  • Typical changes on chest x-ray and/or lung-CT scan
  • Immunosuppression or neoplastic disease
  • Informed Consent as documented by signature (Appendix Informed Consent Form) of the patient or, in case of inability, of the next relative/care-taking person. In the latter case, an independent doctor will also be involved and her/his signature will be required in order to enrol the patient.

Who cannot join

  • Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product (FFP)
  • Known IgA deficiency
  • Cytokine Release Syndrome grade ≥3 (see score)*
  • ARDS
  • Patients already hospitalized in intensive care unit and/or already receiving mechanical ventilation
  • Known or suspected non-compliance, drug or alcohol abuse
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  • Previous enrolment into the current study
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • Women who are pregnant or breast feeding
  • Intention to become pregnant during the course of the study
  • Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Phase i, Open-label, Single-centre Clinical Study to Evaluate Safety and Efficacy of Passive Immunization of High-risk SARS-CoV-2 Positive Patients With Convalescent Plasma Therapy

This is an open-label, single-center, phase I study to assess the safety and efficacy of convalescent plasma therapy (CPT) obtained from donors who were tested positive for SARS-CoV-2 and fully recovered from the infection and administered to patients who are infected with the new coronavirus and present dyspnea or a poor prognosis

Read the detailed description

The outbreak of a new highly contagious and life-threatening infective disease was first reported in China in December 2019. Regardless of the undertaken containing measures, its spreading could not be effectively stopped and currently we are confronting the pandemic diffusion of a newly identified Coronavirus (SARS-CoV-2) (1). This causes a systemic disease, known as (Coronavirus Disease-19) COVID-19, characterised by a broad spectrum of clinical manifestations, including ineffective hyper-inflammation and severe pneumonia, with provisional epidemiologic data indicating a mortality rate of 0.1-15% (2). Do to the lack of vaccination, specific anti-virus sera or monoclonal antibodies, the therapeutic efforts to limit COVID-19 mostly rely on the empirical use of anti-viral drugs. Therefore, being the option of an active immunisation not available and because of the controversial efficacy of the available anti-viral therapies (3), we suggest the option of a passive immunisation for those patients who are infected with the new coronavirus and present dyspnea or a poor prognosis. The use of convalescent plasma, i.e. plasma obtained from donors who were tested positive for SARS-CoV-2 and fully recovered from the infection, could provide a rapid protection, limiting the observed evolution of COVID-19 towards life-threating manifestations (7-9).

When carried on according to standardised measures, the transfusion of plasma is highly safe (10-11) and we assume that products containing anti- SARS-CoV- 2 antibodies will provide the recipients a passive immunity through different mechanisms, including viral neutralisation, antibody-dependent cellular cytotoxicity and/or phagocytosis.

Conditions
COVID-19
Being tested
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.

  • Convalescent plasmaDrug

    Also called Fresh Frozen Plasma (FFP)

    Convalescent plasma will be delivered as FFP. Three units of 200ml CP/FFP harvested from one donor will be transfused to one recipient, i.e. there will be a match between donor and recipient and each recipient will receive CP/FFP only from one donor.

    CP/FFP will be administered intravenously at the infusion rate of 100ml/hour, starting from day 0, with a new transfusion every 24 hours, for a total of 3 transfusions (see scheme).

What is being measured

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

  1. Safety of CPT applied to COVID-19 patients

    Absence of clinical signs of Transfusion Related Lung Inflammation (TRALI) and/or allergic reactions and/or Transfusion Associated Circulatory Overload (TACO)

    Measured: clinical observation up to 48 hours after the last dose of plasma

  2. Safety of CPT applied to COVID-19 patients

    Absence of laboratory signs of haemolytic reactions

    Measured: 1 week (laboratory monitoring up to 7 days after the last administration of plasma)

  3. Improvement of respiratory frequency

    Respiratory frequency will be measured at each study visit

    Measured: 3 weeks after the last administration of plasma

  4. Improvement of O2-saturation

    O2-Saturation will be measured at each study visit

    Measured: 3 weeks after the last administration of plasma

  5. Improvement of Inflammatory markers (C Reactive Protein, CRP)

    CRP will be measured at each study visit

    Measured: 3 weeks after the last administration of plasma

  6. Improvement of Inflammatory markers (Ferritin)

    Ferritin will be measured at each study visit

    Measured: 3 weeks after the last administration of plasma

  7. Improvement of Inflammatory markers (IL-6)

    IL-6 will be measured at each study visit

    Measured: 3 weeks after the last administration of plasma

  8. Improvement of coagulation-markers (D-dimer)

    D-Dimer will be measured at each study visit

    Measured: 3 weeks after the last administration of plasma

  9. Improvement of coagulation-markers (Fibrinogen)

    Fibrinogen will be measured at each study visit

    Measured: 3 weeks after the last administration of plasma

  10. Improvement of coagulation-markers (LDH)

    LDH will be measured at each study visit

    Measured: 3 weeks after the last administration of plasma

  11. Prevention of ICU-admission

    clinical conditions will be assessed throughout the study

    Measured: 3 weeks after the last administration of plasma

Secondary outcomes (3)

  1. Characterisation of virus reaction to plasma Therapy

    Measurement of viral load after plasma therapy

    Measured: 10 Weeks

  2. Characterisation of the dynamic of humoral response after therapy

    Measurement of antibody-titres after plasma therapy

    Measured: 10 Weeks

  3. Better characterize the the in-vivo anti-virus humoral response against SARS-CoV-2.

    Performance of neutralisation assay after administration of plasma

    Measured: 10 Weeks

Timeline

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

  1. First posted3 May 2021
  2. Study start29 Apr 2020
  3. Primary completion30 Nov 2020
  4. Study completion30 Mar 2021

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open-label, single-center, phase I study to assess the safety and efficacy of convalescent plasma therapy (CPT).
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04869072
Sponsor's protocol ID
2020-00787
Acronym
CPT-ZHP
Status last verified
Apr 2021
First submitted
8 Apr 2021
Last updated
3 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marconato M, Abela IA, Hauser A, Schwarzmuller M, Katzensteiner R, Braun DL, Epp S, Audige A, Weber J, Rusert P, Schindler E, Pasin C, West E, Boni J, Kufner V, Huber M, Zaheri M, Schmutz S, Frey BM, Kouyos RD, Gunthard HF, Manz MG, Trkola A. Antibodies from convalescent plasma promote SARS-CoV-2 clearance in individuals with and without endogenous antibody response. J Clin Invest. 2022 Jun 15;132(12):e158190. doi: 10.1172/JCI158190.

    PubMed 35482408

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Convalescent plasma in people with COVID-19, run by University of Zurich at 1 site in Switzerland.

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 14 inclusion and 11 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 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Safety of CPT applied to COVID-19 patients (time frame: clinical observation up to 48 hours after the last dose of plasma). The study lists 11 primary outcomes in all. 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 NCT04869072, which also lists 1 linked publication.

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 3 May 2021.

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