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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05439044
• Collaborator: (none)
• Enrollment: 4,000
• Location: 1
• Anticipated Duration (Months): 34
• Patients Per Site Per Month: 117.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Immunocompromised Patients	Other: Data collection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies in Patients at High Risk of Severe Forms of Covid-19
• Actual Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. Hospitalizations rate [29 days after last administration]

   Explore the hospitalizations rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in prophylaxis

2. Mortality rate [29 days after last administration]

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

3. 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 prophylaxis

4. 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 prophylaxis

5. Hospitalizations rate [29 days after last administration]

   Explore the hospitalizations rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in healing

6. Mortality rate [29 days after last administration]

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

7. 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

8. 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

9. Proportion of hospitalizations [29 days after last administration]

   Proportion of hospitalizations from all causes, in patients treated prophylactically and curatively by anti-SARS-CoV-2 monoclonal antibodies

10. Proportion of deaths [29 days after last administration]

    Proportion of deaths from all causes, in patients treated prophylactically and curatively by anti-SARS-CoV-2 monoclonal antibodies

11. 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

12. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital	Paris	Ile De France	France	75014

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT05439044
• Other Study ID Numbers: APHP220631
• First Posted: Jun 30, 2022
• Last Update Posted: Jul 8, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Covid-19; SARS-CoV-2; Immunocompromised; Monoclonal Antibodies; Mortality

Study Results

No Results Posted as of Jul 8, 2022