A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies in Prophylaxis and Curative of Covid-19 (COVIMAB)

NCT05439044 | Completed

• 1 other identifier: APHP220631
• Study Type: observational
• Target: 4,235
• Locations: 1 country
• Sites: 1

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).

Conditions

Immunocompromised Patients

Keywords

Covid-19; SARS-CoV-2; Immunocompromised; Monoclonal Antibodies; Mortality

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  Covid-19 mortality : Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies

  29 days after last administration

Secondary Outcomes (12)

• 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

Study Arms (1)

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.

Other: Data collection

Interventions

Data collection OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult hospital patients treated with anti-SARS-CoV-2 monoclonal antibodies.

You may qualify if:

• 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

You may not qualify if:

• Patients opposed to the collection of their personal data

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

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

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jeremie Zerbit, PharmD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: August 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)