Status:
COMPLETED
Convalescent Plasma Therapy - Zurich Protocol
Lead Sponsor:
University of Zurich
Conditions:
COVID-19
Eligibility:
All Genders
Phase:
PHASE1
Brief 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 recove...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04869072
Start Date
April 29 2020
End Date
March 30 2021
Last Update
May 3 2021
Active Locations (1)
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1
University Hospital Zurich
Zurich, Switzerland, 8091