- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
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Zürich, Suisse, 8091
- University Hospital Zurich
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Safety of CPT applied to COVID-19 patients
Délai: 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
Délai: 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
Délai: 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
Délai: 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
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Improvement of Inflammatory markers (C Reactive Protein, CRP)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 3 weeks after the last administration of plasma
|
LDH will be measured at each study visit
|
3 weeks after the last administration of plasma
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Prevention of ICU-admission
Délai: 3 weeks after the last administration of plasma
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clinical conditions will be assessed throughout the study
|
3 weeks after the last administration of plasma
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Characterisation of virus reaction to plasma Therapy
Délai: 10 Weeks
|
Measurement of viral load after plasma therapy
|
10 Weeks
|
Characterisation of the dynamic of humoral response after therapy
Délai: 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.
Délai: 10 Weeks
|
Performance of neutralisation assay after administration of plasma
|
10 Weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Markus Manz, Professor, University of Zurich
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2020-00787
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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Essais cliniques sur COVID-19 [feminine]
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Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkPas encore de recrutementSyndrome post-COVID-19 | Longue COVID | Longue Covid19 | État post-COVID-19 | Syndrome post-COVID | Condition post-COVID-19, non précisée | État post-COVIDPays-Bas
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University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlComplétéSéquelles post-aiguës de la COVID-19 | État post-COVID-19 | Long-COVID | Syndrome chronique du COVID-19Italie
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Indonesia UniversityRecrutementSyndrome post-COVID-19 | Longue COVID | État post-COVID-19 | Syndrome post-COVID | Longue COVID-19Indonésie
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Yang I. PachankisActif, ne recrute pasInfection respiratoire COVID-19 | Syndrome de stress COVID-19 | Effet indésirable du vaccin COVID-19 | Thromboembolie associée au COVID-19 | Syndrome de soins post-intensifs COVID-19 | AVC associé à la COVID-19Chine
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Massachusetts General HospitalRecrutementSyndrome post-aigu COVID-19 | Longue COVID | Séquelles post-aiguës de la COVID-19 | Longue COVID-19États-Unis
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Sheba Medical CenterInconnue
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Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecrutementPandémie de covid-19 | Vaccins contre le covid-19 | Maladie à virus COVID-19Indonésie
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University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecrutementCOVID-19 Pneumonie | Infection respiratoire COVID-19 | Pandémie de covid-19 | COVID-19 Syndrome de Détresse Respiratoire Aiguë | COVID-19-Pneumonie associée | Coagulopathie associée au COVID 19 | COVID-19 (maladie à coronavirus 2019) | Thromboembolie associée au COVID-19Grèce
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First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin No.2 Hospital et autres collaborateursRecrutementCOVID-19 [feminine] | Syndrome post-COVID-19 | COVID-19 post-aiguë | COVID-19 aiguëChine
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Jonathann Kuo, MDActif, ne recrute pasInfection par le SRAS-CoV2 | Syndrome post-COVID-19 | Dysautonomie | Syndrome post-aigu COVID-19 | Longue COVID | Longue Covid19 | COVID-19 récurrent | COVID-19 post-aiguë | Infection COVID-19 post-aiguë | Séquelles post-aiguës de la COVID-19 | Dysautonomie comme trouble | Dysautonomie Syndrome d'hypotension... et d'autres conditionsÉtats-Unis
Essais cliniques sur Convalescent plasma
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Noah MerinJohns Hopkins UniversityRésiliéCovid-19 | SRAS-CoV-2États-Unis
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Federal Research Clinical Center of Federal Medical...ComplétéCOVID-19 [feminine]Fédération Russe
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West Virginia UniversityRecrutementInfections par virus à ARN | Maladies virales | Infection par coronavirus | Coronavirus | COVID-19 [FEMININEÉtats-Unis
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Thomas BenfieldRésiliéCOVID | Infection par corona virus | Pneumonie viraleDanemark
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Universidad del RosarioCES University; Fundación Universitaria de Ciencias de la Salud; Instituto Distrital...ComplétéInfection par coronavirus | CoronavirusColombie
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Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-HessenComplété
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Henry Ford Health SystemComplétéInfection par coronavirus | COVID | CoronavirusÉtats-Unis
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Universidad Peruana Cayetano HerediaComplétéCOVID-19 [feminine]Pérou
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Ministry of Health and Population, EgyptComplétéCovid19 | Plasma | Plasma convalescent | Immunoglobulines | EgypteEgypte