NCT04981769

Brief Summary

Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

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

July 27, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

August 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

July 27, 2021

Last Update Submit

July 27, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Covid-19 PCR test result

    Molecular Covid-19 testing

    90 minutes

Study Arms (1)

Patients

Patients presenting to clinical sites for Covid-19 testing who are 2 years of age or older.

Diagnostic Test: Covid-19 test

Interventions

Covid-19 testDIAGNOSTIC_TEST

PCR Covid-19 test

Patients

Eligibility Criteria

Age2 Years - 125 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible subjects presenting to clinical site for Covid-19 testing

You may qualify if:

  • Subjects presenting to clinical site for Covid-19 testing. Completion of signed written informed consent process.

You may not qualify if:

  • Inability to complete signed written informed consent process. Younger than 2 years of age. Any contraindication to Covid-19 swab testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Michael Blaivas, MD

CONTACT

770-205-7721mike.blaivas@anavasidx.com

Study Design

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

Study Record Dates

First Submitted

July 27, 2021

First Posted

July 29, 2021

Study Start

August 2, 2021

Primary Completion

September 30, 2021

Study Completion

November 30, 2021

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share