Pre-exposure Prophylaxis of SARS-CoV-2 Infection (COVID-19) by Monoclonal Antibodies with Early Access Authorization in Immunocompromised Patients. a Prospective Cohort. (PRECOVIM)

ANRS, Emerging Infectious Diseases

Status: Completed

Conditions: COVID-19; Immunocompromised Host

Study type: Observational

Funder types: Other

Identifiers

NCT05216588

2021-006961-39 (EudraCT Number)

ANRS0166s PRECOVIM

Details and patient eligibility

About

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 concerns

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

149 participants in 2 patient groups

EVUSHELD (tixagévimab/cilgavimab) 300 mg

Description:

Patients who may be included in this group are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) of EVUSHELD 300mg. Patient are treated and monitored according to the Therapeutic Use Protocols specific for EVUSHELD defined by the ANSM. In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research.

EVUSHELD (tixagévimab/cilgavimab) 600 mg

Description:

Patients who may be included in this group are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) of EVUSHELD 600mg. Patient are treated and monitored according to the Therapeutic Use Protocols specific for EVUSHELD defined by the ANSM. In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research.