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

A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies in Patients at High Risk of Severe Forms of Covid-19

Sponsors

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Source Assistance Publique - Hôpitaux de Paris
Brief Summary

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).

Overall Status Recruiting
Start Date 2020-03-01
Completion Date 2022-12-31
Primary Completion Date 2022-12-31
Study Type Observational
Primary Outcome
Measure Time Frame
Mortality rate 29 days after last administration
Secondary Outcome
Measure Time Frame
Hospitalizations rate 29 days after last administration
Mortality rate 29 days after last administration
Hospitalizations rate 90 days after last administration
Mortality rate 90 days after last administration
Hospitalizations rate 29 days after last administration
Mortality rate 29 days after last administration
Hospitalizations rate 90 days after last administration
Mortality rate 90 days after last administration
Proportion of hospitalizations 29 days after last administration
Proportion of deaths 29 days after last administration
Proportion of hospitalizations 90 days after last administration
Proportion of deaths 90 days after last administration
Enrollment 4000
Condition
Intervention

Intervention Type: Other

Intervention Name: Data collection

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

Arm Group Label: Patients who have received an anti-SARS-CoV-2 monoclonal antibody

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jeremie Zerbit, PharmD Principal Investigator Pharmacy Department, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
Overall Contact

Last Name: Jeremie Zerbit, PharmD

Phone: 00 33 1 58 41 41 41

Email: [email protected]

Location
Facility: Status: Contact: Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital Jeremie ZERBIT, PharmD [email protected]
Location Countries

France

Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

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

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

Acronym COVIMAB
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

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Clinical Trials on Immunocompromised Patients

Clinical Trials on Data collection