Status:
COMPLETED
Pre-exposure Prophylaxis of SARS-CoV-2 Infection (COVID-19) by Monoclonal Antibodies with Early Access Authorization in Immunocompromised Patients. a Prospective Cohort.
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Conditions:
COVID-19
Immunocompromised Host
Eligibility:
All Genders
18+ years
Brief Summary
This prospective cohort of patients, receiving pre exposure prophylaxis by Anti-SARS-CoV-2 Monoclonal Antibodies, is designed to evaluate the treatment protection against SARS-CoV-2 variants of concer...
Eligibility Criteria
Inclusion
- Adults (18 years-old or more)
- Patient who received the first administration of Evusheld at 300 mg for less than 4 months and should receive a second dose, according to French recommendations OR Patient scheduled to receive or having received less than a month ago an injection of anti-SARS-CoV-2 monoclonal antibodies, as pre-exposure prophylaxis at 600 mg, according to the French SARS-CoV-2 RT recommendations
- qPCR negative at baseline
- SARS-CoV-2 RT-qPCR Negative at inclusion
- Patients who remain seronegative after a complete COVID-19 vaccination schedule
- Immunocompromised patients :
- Hemopathy : chronic lymphoid leukemia, non hodgkin's lymphoma, HSCT Transplant recipient : kidney, liver, lungs Patients receiving anti CD20 or others immunosuppressor
- Life expectancy \> 3 months
- Social security affiliation
- Lack of a legal protection measure
- Signed informed consent
Exclusion
- Participation to another clinical study
- State medical aid
- Ongoing or scheduled plasmapheresis or immunoadsorption
- Pregnant / lactating woman
- Patient whose isolation period is underway following contact with a confirmed case of SARS-CoV2 infection
- Hypersensitivity to one of the active substances or to one of the excipients
Key Trial Info
Start Date :
January 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT05216588
Start Date
January 26 2022
End Date
October 31 2024
Last Update
January 29 2025
Active Locations (1)
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1
Hôpital Avicenne
Bobigny, France, 93000