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

Immunocompromised Patients Clinical Trial

— COVIMAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05439044
• Other study ID #: APHP220631
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jeremie Zerbit, PharmD
• Phone: 00 33 1 58 41 41 41
• Email: jeremie.zerbit[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunocompromised Patients

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospitalizations rate	Explore the hospitalizations rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in prophylaxis	29 days after last administration
Secondary	Mortality rate	Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in prophylaxis	29 days after last administration
Secondary	Hospitalizations rate	Explore the hospitalizations rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in prophylaxis	90 days after last administration
Secondary	Mortality rate	Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in prophylaxis	90 days after last administration
Secondary	Hospitalizations rate	Explore the hospitalizations rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in healing	29 days after last administration
Secondary	Mortality rate	Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in healing	29 days after last administration
Secondary	Hospitalizations rate	Explore the hospitalizations rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in healing	90 days after last administration
Secondary	Mortality rate	Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in healing	90 days after last administration
Secondary	Proportion of hospitalizations	Proportion of hospitalizations from all causes, in patients treated prophylactically and curatively by anti-SARS-CoV-2 monoclonal antibodies	29 days after last administration
Secondary	Proportion of deaths	Proportion of deaths from all causes, in patients treated prophylactically and curatively by anti-SARS-CoV-2 monoclonal antibodies	29 days after last administration
Secondary	Proportion of hospitalizations	Proportion of hospitalizations from all causes, in patients treated prophylactically and curatively by anti-SARS-CoV-2 monoclonal antibodies	90 days after last administration
Secondary	Proportion of deaths	Proportion of deaths from all causes, in patients treated prophylactically and curatively by anti-SARS-CoV-2 monoclonal antibodies	90 days after last administration