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

COVID-19 Clinical Trial

— PRECOVIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05216588
• Other study ID #: ANRS0166s PRECOVIM
• Secondary ID: 2021-006961-39
• Status: Recruiting
• Start date: January 26, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: January 2023
• Source: ANRS, Emerging Infectious Diseases
• Contact: Vincent LEVY, MD, PhD
• Phone: +33 1 48 95 77 33
• Email: vincent.levy[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 30, 2024
• Est. primary completion date: June 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Immunocompromised Host

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny

Sponsors (1)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

France, 

References & 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, Got — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutralizing antibody activity		Month 1
Primary	Neutralizing antibody activity		Month 2
Primary	Neutralizing antibody activity		Month 3
Primary	Neutralizing antibody activity		Month 4
Primary	Neutralizing antibody activity		Month 5
Primary	Neutralizing antibody activity		Month 6
Primary	Neutralizing antibody activity		Month 9
Primary	Neutralizing antibody activity		Month 12
Secondary	Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR) and symptoms of SARS-CoV-2 infection		Month 12
Secondary	Proportion of subjects hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection during prophylaxis period		Month 12
Secondary	Proportion of patients infected with a resistant variant		Month 12
Secondary	Proportion of patients with treatment AE		Month 12
Secondary	Severity of treatment AE		Month 12
Secondary	Proportion of patients with SAE		Month 12
Secondary	Proportion of patients with suspended prophylaxis due to adverse event		Month 12
Secondary	Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it		Month 1
Secondary	Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it		Month 2
Secondary	Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it		Month 3
Secondary	Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it		Month 4
Secondary	Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it		Month 5
Secondary	Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it		Month 6
Secondary	Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it		Month 9
Secondary	Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it		Month 12
Secondary	Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies		Month 1
Secondary	Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies		Month 2
Secondary	Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies		Month 3
Secondary	Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies		Month 4
Secondary	Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies		Month 5
Secondary	Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies		Month 6
Secondary	Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies		Month 9
Secondary	Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies		Month 12
Secondary	Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2		Month 1
Secondary	Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2		Month 2
Secondary	Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2		Month 3
Secondary	Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2		Month 4
Secondary	Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2		Month 5
Secondary	Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2		Month 6
Secondary	Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2		Month 9
Secondary	Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2		Month 12
Secondary	Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2		Month 1
Secondary	Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2		Month 2
Secondary	Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2		Month 3
Secondary	Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2		Month 4
Secondary	Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2		Month 5
Secondary	Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2		Month 6
Secondary	Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2		Month 9
Secondary	Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2		Month 12
Secondary	Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.		Month 1
Secondary	Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.		Month 2
Secondary	Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.		Month 3
Secondary	Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.		Month 4
Secondary	Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.		Month 5
Secondary	Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.		Month 6
Secondary	Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.		Month 9
Secondary	Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.		Month 12
Secondary	Anti-S et Anti- N antibodies levels		Month 1
Secondary	Anti-S et Anti- N antibodies levels		Month 2
Secondary	Anti-S et Anti- N antibodies levels		Month 3
Secondary	Anti-S et Anti- N antibodies levels		Month 4
Secondary	Anti-S et Anti- N antibodies levels		Month 5
Secondary	Anti-S et Anti- N antibodies levels		Month 6
Secondary	Anti-S et Anti- N antibodies levels		Month 9
Secondary	Anti-S et Anti- N antibodies levels		Month 12