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
A tanulmány áttekintése
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- 1. fázis
Kapcsolatok és helyek
Tanulmányi helyek
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Zürich, Svájc, 8091
- University Hospital Zurich
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Gyermek
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Safety of CPT applied to COVID-19 patients
Időkeret: clinical observation up to 48 hours after the last dose of plasma
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Absence of clinical signs of Transfusion Related Lung Inflammation (TRALI) and/or allergic reactions and/or Transfusion Associated Circulatory Overload (TACO)
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clinical observation up to 48 hours after the last dose of plasma
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Safety of CPT applied to COVID-19 patients
Időkeret: 1 week (laboratory monitoring up to 7 days after the last administration of plasma)
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Absence of laboratory signs of haemolytic reactions
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1 week (laboratory monitoring up to 7 days after the last administration of plasma)
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Improvement of respiratory frequency
Időkeret: 3 weeks after the last administration of plasma
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Respiratory frequency will be measured at each study visit
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3 weeks after the last administration of plasma
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Improvement of O2-saturation
Időkeret: 3 weeks after the last administration of plasma
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O2-Saturation will be measured at each study visit
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3 weeks after the last administration of plasma
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Improvement of Inflammatory markers (C Reactive Protein, CRP)
Időkeret: 3 weeks after the last administration of plasma
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CRP will be measured at each study visit
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3 weeks after the last administration of plasma
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Improvement of Inflammatory markers (Ferritin)
Időkeret: 3 weeks after the last administration of plasma
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Ferritin will be measured at each study visit
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3 weeks after the last administration of plasma
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Improvement of Inflammatory markers (IL-6)
Időkeret: 3 weeks after the last administration of plasma
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IL-6 will be measured at each study visit
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3 weeks after the last administration of plasma
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Improvement of coagulation-markers (D-dimer)
Időkeret: 3 weeks after the last administration of plasma
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D-Dimer will be measured at each study visit
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3 weeks after the last administration of plasma
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Improvement of coagulation-markers (Fibrinogen)
Időkeret: 3 weeks after the last administration of plasma
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Fibrinogen will be measured at each study visit
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3 weeks after the last administration of plasma
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Improvement of coagulation-markers (LDH)
Időkeret: 3 weeks after the last administration of plasma
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LDH will be measured at each study visit
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3 weeks after the last administration of plasma
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Prevention of ICU-admission
Időkeret: 3 weeks after the last administration of plasma
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clinical conditions will be assessed throughout the study
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3 weeks after the last administration of plasma
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Characterisation of virus reaction to plasma Therapy
Időkeret: 10 Weeks
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Measurement of viral load after plasma therapy
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10 Weeks
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Characterisation of the dynamic of humoral response after therapy
Időkeret: 10 Weeks
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Measurement of antibody-titres after plasma therapy
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10 Weeks
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Better characterize the the in-vivo anti-virus humoral response against SARS-CoV-2.
Időkeret: 10 Weeks
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Performance of neutralisation assay after administration of plasma
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10 Weeks
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi szék: Markus Manz, Professor, University of Zurich
Publikációk és hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- 2020-00787
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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