A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies

NCT ID: NCT05439044

Last Updated: 2022-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-12-31

Brief Summary

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Absence of anti-SARS-CoV-2 vaccine response or insufficient vaccine response may occur in immunocompromised patients. Being at high risk of a severe form of Covid-19, they may be eligible to receive recombinant anti-SARS-CoV-2 monoclonal antibodies (mAbs). This study aims to describe patients who received anti-SARS-CoV-2 mAbs, in prophylaxis and/or curative of covid-19, and to analyze the hospitalization and mortality rates. This study is multicentric on all the university hospitals of Paris (AP-HP).

Detailed Description

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Conditions

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Immunocompromised Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients who have received an anti-SARS-CoV-2 monoclonal antibody

Patients who have received an anti-SARS-CoV-2 monoclonal antibody, either prophylactically or curatively.

Data collection

Intervention Type OTHER

Anti SARS-CoV-2 Monoclonal Antibodies: casirivimab-imdevimab (Ronapreve) OR bamlanivimab-etesevimab OR tixagevimab-cilgavimab (Evusheld) OR regdanvimab OR sotrovimab (Xevudy) OR adintrevimab

Interventions

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Data collection

Anti SARS-CoV-2 Monoclonal Antibodies: casirivimab-imdevimab (Ronapreve) OR bamlanivimab-etesevimab OR tixagevimab-cilgavimab (Evusheld) OR regdanvimab OR sotrovimab (Xevudy) OR adintrevimab

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult ≥ 18 years old
* Patients who received at least one administration of the following therapies: casirivimab-imdevimab, bamlanivimab-etesevimab, tixagevimab-cilgavimab, regdanvimab, sotrovimab or adintrevimab

Exclusion Criteria

* Patients opposed to the collection of their personal data
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremie Zerbit, PharmD

Role: PRINCIPAL_INVESTIGATOR

Pharmacy Department, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Locations

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Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jeremie Zerbit, PharmD

Role: CONTACT

00 33 1 58 41 41 41

Marie BENHAMMANI-GODARD

Role: CONTACT

0033 1 58411190

Facility Contacts

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Jeremie ZERBIT, PharmD

Role: primary

Other Identifiers

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APHP220631

Identifier Type: -

Identifier Source: org_study_id

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