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

• Conditions: Immunocompromised Patients
• Interventions: Other: Data collection

• Registration Number: NCT05439044
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Status Verified: 2022-06
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-08
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who have received an anti-SARS-CoV-2 monoclonal antibody	Data collection	Patients who have received an anti-SARS-CoV-2 monoclonal antibody, either prophylactically or curatively.

Primary Outcome Measures

Name	Time	Method
Mortality rate	29 days after last administration	Covid-19 mortality : Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies

Secondary Outcome Measures

Name	Time	Method
Hospitalizations rate	90 days after last administration	Explore the hospitalizations rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in healing
Proportion of deaths	90 days after last administration	Proportion of deaths from all causes, in patients treated prophylactically and curatively by anti-SARS-CoV-2 monoclonal antibodies
Mortality rate	90 days after last administration	Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in healing
Proportion of hospitalizations	90 days after last administration	Proportion of hospitalizations from all causes, in patients treated prophylactically and curatively by anti-SARS-CoV-2 monoclonal antibodies

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital; 🇫🇷 Paris, Ile De France, France