NCT04467008

Brief Summary

This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

November 10, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

July 9, 2020

Last Update Submit

November 9, 2020

Conditions

Covid19

Keywords

Covid 19DiagnosticBiosynexBlood drop

Outcome Measures

Primary Outcomes (1)

  • Positivity of the rapid diagnostic test

    Positivity of the rapid diagnostic test, assessed by the presence of either IgM or IgG

    Immediate, up to 1 day.

Study Arms (1)

One group of patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with confirmed COVID-19 pneumonia (using RT-PCR) who required hospitalization in intensive care unit.

You may qualify if:

  • Confirmed COVID-19 diagnosis with at least one positive RT-PCR

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMC Ambroise Paré

Neuilly-sur-Seine, 92200, France

Location

MeSH Terms

Conditions

COVID-19Disease

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lee Nguyen, MD

    CMC Ambroise Paré

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 10, 2020

Study Start

July 15, 2020

Primary Completion

August 15, 2020

Study Completion

August 15, 2020

Last Updated

November 10, 2020

Record last verified: 2020-07

Locations

FR(1)