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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Immunocompromised Patients
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

• Study Contact: Name: Jeremie Zerbit, PharmD; Phone Number: 00 33 1 58 41 41 41; Email: jeremie.zerbit@aphp.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75014
      • Recruiting
      • Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital
      • Contact: Jeremie ZERBIT, PharmD; Email: jeremie.zerbit@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Anti SARS-CoV-2 Monoclonal Antibodies: casirivimab-imdevimab (Ronapreve) OR bamlanivimab-etesevimab OR tixagevimab-cilgavimab (Evusheld) OR regdanvimab OR sotrovimab (Xevudy) OR adintrevimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Jeremie Zerbit, PharmD, Pharmacy Department, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (ACTUAL): June 30, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Covid-19; Mortality; Immunocompromised; Monoclonal Antibodies
• Other Study ID Numbers: APHP220631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No