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OpenTrials
Completed

NCT Number: NCT05216588

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Immunocompromised Host Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Avicenne

Bobigny, 93000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Neutralizing antibody activity

    Time frame: Month 1

  2. Neutralizing antibody activity

    Time frame: Month 2

  3. Neutralizing antibody activity

    Time frame: Month 3

  4. Neutralizing antibody activity

    Time frame: Month 4

  5. Neutralizing antibody activity

    Time frame: Month 5

  6. Neutralizing antibody activity

    Time frame: Month 6

  7. Neutralizing antibody activity

    Time frame: Month 9

  8. Neutralizing antibody activity

    Time frame: Month 12

Secondary outcomes

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

    Time frame: Month 12

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

    Time frame: Month 12

  3. Proportion of patients infected with a resistant variant

    Time frame: Month 12

  4. Proportion of patients with treatment AE

    Time frame: Month 12

  5. Severity of treatment AE

    Time frame: Month 12

  6. Proportion of patients with SAE

    Time frame: Month 12

  7. Proportion of patients with suspended prophylaxis due to adverse event

    Time frame: Month 12

  8. Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

    Time frame: Month 1

  9. Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

    Time frame: Month 2

  10. Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

    Time frame: Month 3

  11. Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

    Time frame: Month 4

  12. Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

    Time frame: Month 5

  13. Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

    Time frame: Month 6

  14. Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

    Time frame: Month 9

  15. Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

    Time frame: Month 12

  16. Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

    Time frame: Month 1

  17. Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

    Time frame: Month 2

  18. Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

    Time frame: Month 3

  19. Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

    Time frame: Month 4

  20. Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

    Time frame: Month 5

  21. Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

    Time frame: Month 6

  22. Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

    Time frame: Month 9

  23. Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

    Time frame: Month 12

  24. Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2

    Time frame: Month 1

  25. Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2

    Time frame: Month 2

  26. Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2

    Time frame: Month 3

  27. Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2

    Time frame: Month 4

  28. Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2

    Time frame: Month 5

  29. Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2

    Time frame: Month 6

  30. Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2

    Time frame: Month 9

  31. Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2

    Time frame: Month 12

  32. Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2

    Time frame: Month 1

  33. Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2

    Time frame: Month 2

  34. Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2

    Time frame: Month 3

  35. Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2

    Time frame: Month 4

  36. Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2

    Time frame: Month 5

  37. Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2

    Time frame: Month 6

  38. Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2

    Time frame: Month 9

  39. Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2

    Time frame: Month 12

  40. Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.

    Time frame: Month 1

  41. Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.

    Time frame: Month 2

  42. Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.

    Time frame: Month 3

  43. Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.

    Time frame: Month 4

  44. Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.

    Time frame: Month 5

  45. Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.

    Time frame: Month 6

  46. Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.

    Time frame: Month 9

  47. Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.

    Time frame: Month 12

  48. Anti-S et Anti- N antibodies levels

    Time frame: Month 1

  49. Anti-S et Anti- N antibodies levels

    Time frame: Month 2

  50. Anti-S et Anti- N antibodies levels

    Time frame: Month 3

  51. Anti-S et Anti- N antibodies levels

    Time frame: Month 4

  52. Anti-S et Anti- N antibodies levels

    Time frame: Month 5

  53. Anti-S et Anti- N antibodies levels

    Time frame: Month 6

  54. Anti-S et Anti- N antibodies levels

    Time frame: Month 9

  55. Anti-S et Anti- N antibodies levels

    Time frame: Month 12

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Acronym: PRECOVIM

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 31, 2022
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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