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

NCT05216588 | Completed

• 2 other identifiers: ANRS0166s PRECOVIM2021-006961-39
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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 concerns

Conditions

COVID-19; Immunocompromised Host

Keywords

Post-Exposure Prophylaxis; Antibodies Monoclonal; Neutralizing Antibodies

Outcome Measures

Primary Outcomes (8)

• Neutralizing antibody activity

  Month 1

• Neutralizing antibody activity

  Month 2

• Neutralizing antibody activity

  Month 3

• Neutralizing antibody activity

  Month 4

• Neutralizing antibody activity

  Month 5

• Neutralizing antibody activity

  Month 6

• Neutralizing antibody activity

  Month 9

• Neutralizing antibody activity

  Month 12

Secondary Outcomes (55)

• Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR) and symptoms of SARS-CoV-2 infection

  Month 12

• Proportion of subjects hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection during prophylaxis period

  Month 12

• Proportion of patients infected with a resistant variant

  Month 12

• Proportion of patients with treatment AE

  Month 12

• Severity of treatment AE

  Month 12

Study Arms (2)

EVUSHELD (tixagévimab/cilgavimab) 300 mg

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who may be included in the cohort are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) or full market approval. In case of ATUc, patient are treated and monitored according to the Therapeutic Use Protocols specific for each ATU treatment 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

Hôpital Avicenne

Bobigny, 93000, France

Location

Related Publications (1)

• de Lamballerie X, Martin-Blondel G, Dupont A, Izopet J, Mentre F, Kamar N, Autran B, Paintaud G, Caillard S, le Bourgeois A, Richez C, Couzi L, Xhaard A, Marjanovic Z, Avouac J, Jacquet C, Anglicheau D, Cheminant M, Yazdanpanah Y, Guyen SN, Terrier B, Gottenberg JE, Besson C, Letrou S, Kali S, Angoulvant D, Sanchez VP, Tardivon C, Blancho G, Levy V. Low serum neutralization of Omicron variants a month after AZD7442 prophylaxis initiation. J Infect. 2023 Jan;86(1):66-117. doi: 10.1016/j.jinf.2022.10.006. Epub 2022 Oct 8. No abstract available.

  PMID: 36216187 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, nasopharyngeal swabs

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Vincent LEVY, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: January 31, 2022
• Study Start: January 26, 2022
• Primary Completion: November 3, 2023
• Study Completion: October 31, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

FR (1)