- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04869072
Convalescent Plasma Therapy - Zurich Protocol (CPT-ZHP)
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
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Zürich, Switzerland, 8091
- University Hospital Zürich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
A) 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
- 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
B) 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.
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of CPT applied to COVID-19 patients
Time Frame: clinical observation up to 48 hours after the last dose of plasma
|
Absence of clinical signs of Transfusion Related Lung Inflammation (TRALI) and/or allergic reactions and/or Transfusion Associated Circulatory Overload (TACO)
|
clinical observation up to 48 hours after the last dose of plasma
|
Safety of CPT applied to COVID-19 patients
Time Frame: 1 week (laboratory monitoring up to 7 days after the last administration of plasma)
|
Absence of laboratory signs of haemolytic reactions
|
1 week (laboratory monitoring up to 7 days after the last administration of plasma)
|
Improvement of respiratory frequency
Time Frame: 3 weeks after the last administration of plasma
|
Respiratory frequency will be measured at each study visit
|
3 weeks after the last administration of plasma
|
Improvement of O2-saturation
Time Frame: 3 weeks after the last administration of plasma
|
O2-Saturation will be measured at each study visit
|
3 weeks after the last administration of plasma
|
Improvement of Inflammatory markers (C Reactive Protein, CRP)
Time Frame: 3 weeks after the last administration of plasma
|
CRP will be measured at each study visit
|
3 weeks after the last administration of plasma
|
Improvement of Inflammatory markers (Ferritin)
Time Frame: 3 weeks after the last administration of plasma
|
Ferritin will be measured at each study visit
|
3 weeks after the last administration of plasma
|
Improvement of Inflammatory markers (IL-6)
Time Frame: 3 weeks after the last administration of plasma
|
IL-6 will be measured at each study visit
|
3 weeks after the last administration of plasma
|
Improvement of coagulation-markers (D-dimer)
Time Frame: 3 weeks after the last administration of plasma
|
D-Dimer will be measured at each study visit
|
3 weeks after the last administration of plasma
|
Improvement of coagulation-markers (Fibrinogen)
Time Frame: 3 weeks after the last administration of plasma
|
Fibrinogen will be measured at each study visit
|
3 weeks after the last administration of plasma
|
Improvement of coagulation-markers (LDH)
Time Frame: 3 weeks after the last administration of plasma
|
LDH will be measured at each study visit
|
3 weeks after the last administration of plasma
|
Prevention of ICU-admission
Time Frame: 3 weeks after the last administration of plasma
|
clinical conditions will be assessed throughout the study
|
3 weeks after the last administration of plasma
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterisation of virus reaction to plasma Therapy
Time Frame: 10 Weeks
|
Measurement of viral load after plasma therapy
|
10 Weeks
|
Characterisation of the dynamic of humoral response after therapy
Time Frame: 10 Weeks
|
Measurement of antibody-titres after plasma therapy
|
10 Weeks
|
Better characterize the the in-vivo anti-virus humoral response against SARS-CoV-2.
Time Frame: 10 Weeks
|
Performance of neutralisation assay after administration of plasma
|
10 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Markus Manz, Professor, University of Zurich
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020-00787
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on Convalescent plasma
-
Noah MerinJohns Hopkins UniversityTerminatedCovid-19 | Sars-CoV2United States
-
Gailen D. Marshall Jr., MD PhDUniversity of Mississippi Medical CenterCompleted
-
Federal Research Clinical Center of Federal Medical...Completed
-
Thomas BenfieldTerminatedCOVID | Corona Virus Infection | Viral PneumoniaDenmark
-
Lahore General HospitalUnknown
-
Max O'DonnellNew York Blood Center; Amazon.com, Inc.Completed
-
Henry Ford Health SystemCompletedCoronavirus Infection | COVID | CoronavirusUnited States
-
Universidad Peruana Cayetano HerediaCompleted
-
Ministry of Health and Population, EgyptCompletedCovid19 | Plasma | Convalescent Plasma | Immunoglobulins | EgyptEgypt