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Completed

NCT Number: NCT05439044

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

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).

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Key information

Conditions

Immunocompromised Patients COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Mortality rate

    Time frame: 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 outcomes

  1. Hospitalizations rate

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 90 days after last administration

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: COVIMAB

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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