Immunocompromised PatientsCOVIMABNCT05439044
A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies in Prophylaxis and Curative of Covid-19 (COVIMAB)
An observational study of Immunocompromised Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunocompromised Patients
- What is being tested?
- Data collection
- How many people
- 4,235 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult hospital patients treated with anti-SARS-CoV-2 monoclonal antibodies.
Who may be able to join
- 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
Who cannot join
- Patients opposed to the collection of their personal data
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital
Paris, Île-de-France Region, 75014
About this study
Official title: 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).
- Conditions
- Immunocompromised Patients
- Being tested
- Data collection
- Keywords
- Covid-19, SARS-CoV-2, Immunocompromised, Monoclonal Antibodies, Mortality
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Anti SARS-CoV-2 Monoclonal Antibodies: casirivimab-imdevimab (Ronapreve) OR bamlanivimab-etesevimab OR tixagevimab-cilgavimab (Evusheld) OR regdanvimab OR sotrovimab (Xevudy) OR adintrevimab
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Covid-19 mortality : Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies
Measured: 29 days after last administration
Secondary outcomes (12)
Hospitalizations rate
Explore the hospitalizations rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in prophylaxis
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 90 days after last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Aug 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunocompromised PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jeremie Zerbit, PharmD, Principal investigator, Pharmacy Department, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439044
- Sponsor's protocol ID
- APHP220631
- Acronym
- COVIMAB
- Status last verified
- Apr 2026
- First submitted
- 27 Jun 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies in Patients at High Risk of Severe Forms of Covid-19
- ClinicalTrials.gov ID
- NCT05439044
- Acronym / sponsor ID
- COVIMAB / APHP220631
- Conditions
- Immunocompromised Patients
- Keywords
- Covid-19, SARS-CoV-2, Immunocompromised, Monoclonal Antibodies, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,235 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have received an anti-SARS-CoV-2 monoclonal antibody | – | Other: Data collectionPatients who have received an anti-SARS-CoV-2 monoclonal antibody, either prophylactically or curatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult hospital patients treated with anti-SARS-CoV-2 monoclonal antibodies.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients opposed to the collection of their personal data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionAnti SARS-CoV-2 Monoclonal Antibodies: casirivimab-imdevimab (Ronapreve) OR bamlanivimab-etesevimab OR tixagevimab-cilgavimab (Evusheld) OR regdanvimab OR sotrovimab (Xevudy) OR adintrevimab | Other | Patients who have received an anti-SARS-CoV-2 monoclonal antibody |
Primary outcome
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
12 secondary outcomes
Hospitalizations rate
Time frame: 29 days after last administration
Mortality rate
Time frame: 29 days after last administration
Hospitalizations rate
Time frame: 90 days after last administration
Mortality rate
Time frame: 90 days after last administration
Hospitalizations rate
Time frame: 29 days after last administration
Mortality rate
Time frame: 29 days after last administration
Hospitalizations rate
Time frame: 90 days after last administration
Mortality rate
Time frame: 90 days after last administration
Proportion of hospitalizations
Time frame: 29 days after last administration
Proportion of deaths
Time frame: 29 days after last administration
Proportion of hospitalizations
Time frame: 90 days after last administration
Proportion of deaths
Time frame: 90 days after last administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Immunocompromised Patients
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingPhase 2
Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
Locally Recurrent Skin Squamous Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingObservational study
Aztreonam-Avibactam in Immunocompromised Hosts
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremie Zerbit, PharmD principal investigator
Pharmacy Department, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunocompromised Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: 29 days after last administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.