NCT04377763

Brief Summary

The primary objective of the study aims to evaluate serological assays of virus Covid-19.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

May 5, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

May 5, 2020

Last Update Submit

February 24, 2021

Conditions

COVID-19

Keywords

COVID-19serological assay

Outcome Measures

Primary Outcomes (1)

  • Sensibility and specificity

    Determination of sensibility and specificity of serological testing in SARS-CoV-2 virus in patients with acute respiratory symptoms.

    Throughout of the study, an average of 6 months

Secondary Outcomes (1)

  • Delay between the first symptoms and the positive serological result

    Throughout of the study, an average of 6 months

Eligibility Criteria

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

Adult patients with positive or negative molecular diagnosis of Covid-19, in the Laboratory of Microbiology of Ambroise Paré Hospital.

You may qualify if:

  • Patient ≥ 18 years;
  • Have molecular diagnosis of positive or negative result in Covid-19 virus by the Laboratory of Microbiology in Ambroise Paré Hospital;
  • Have diagnosed of a viral infection in respiratory.

You may not qualify if:

  • \- Patient refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of microbiology of hospital hygiene, Ambroise Paré Hospital, APHP

Boulogne-Billancourt, 92100, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marie-Anne RAMEIX-WELTI, MD, PhD

    Laboratoire de Microbiologie Hygiène hospitalière, Hôpital Ambroise paré, APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Anne RAMEIX-WELTI, MD, PhD

CONTACT

+33 (0)6 65 13 64 34marie-anne.welti@aphp.fr

Study Design

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

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 6, 2020

Study Start

July 15, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)