NCT04575545

Brief Summary

The purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

October 2, 2020

Last Update Submit

October 2, 2020

Conditions

Covid19Virus-HIV

Outcome Measures

Primary Outcomes (1)

  • % of patients with positive serological tests for covid-19

    3 months

Secondary Outcomes (1)

  • Presence and quantification of CD4 / CD8 reactivity to COVID-19 epitopes in patient with positive and negative serological tests for covid-19

    3 months

Study Arms (2)

HIV positive patients

Diagnostic Test: Serology test for COVID-19

Patients taking PrEP

Diagnostic Test: Serology test for COVID-19

Interventions

Serology test for COVID-19DIAGNOSTIC_TEST

ELISA test

HIV positive patientsPatients taking PrEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients infected by the HIV on treatment and patients taking PreP

You may qualify if:

  • Aged ≥ 18 years
  • patients infected by the HIV on treatment
  • patients taking PreP (Pre-exposure prophylaxis (PrEP))
  • Being affiliated with or benefiting from a social security scheme

You may not qualify if:

  • Subject to a measure for the protection of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BENNANI

Marseille, 13003, France

Location

MeSH Terms

Conditions

COVID-19Acquired Immunodeficiency Syndrome

Interventions

Serologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Patrick PHILIBERT

    Hôpital Europeen Marseille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Myriam BENNANI

CONTACT

0413428351m.bennani@hopital-europeen.fr

Study Design

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

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 5, 2020

Study Start

October 1, 2020

Primary Completion

March 1, 2021

Study Completion

April 1, 2022

Last Updated

October 5, 2020

Record last verified: 2020-09

Locations

FR(1)