NCT04599959

Brief Summary

The main objective of the tests is to establish saliva collection with Salivette® Cortisol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable covid19

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

October 22, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

October 26, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
6 months until next milestone

Results Posted

Study results publicly available

July 26, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

October 22, 2020

Results QC Date

July 21, 2021

Last Update Submit

July 21, 2021

Conditions

Covid-19

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico

    Number of participants testing positive or negative for SARS-CoV-2 virus from sample collected via swab versus saliva sample collected from Salivette® Cortisol, which samples were processed in Mexico.

    At baseline (the test day), up to one day.

  • Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany

    Percentage of participants testing true positive or true negative for SARS-CoV-2 virus from Swab and Saliva samples being processed in Germany was reported. The swab sample was used as the reference. Among participants who were tested positive from swab samples, those who were tested positive from saliva samples were classified as "true positive". Among participants tested negative from swab samples, those who were tested negative from saliva samples were then classified as "true negative".

    At baseline (the test day), up to one day.

Study Arms (1)

Overall (Swab/Saliva)

EXPERIMENTAL
Diagnostic Test: Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol

Interventions

Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette CortisolDIAGNOSTIC_TEST

Kylt® for detection/confirmation of SARS-CoV-2 cobas® SARS-CoV-2 (PCR) test TaqPath™ COVID-19 CE-IVD RT-PCR kit

Overall (Swab/Saliva)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent form signed and dated before any samples have been taken.
  • Suspected or confirmed SARS-CoV-2 infection by PCR within the past five days.
  • Male and/or female patients aged 18 years and over.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

México, 14080, Mexico

Location

Related Publications (1)

  • Moroni-Zentgraf P, Keller C, Eschenfelder CC, Walter Muller H, Sigmund R, Galeana-Cadena D, Marquez-Garcia JE, Moncada-Morales A, Zuniga JA. Salivette(R) Cortisol versus oropharyngeal swabbing for the detection of SARS-CoV-2 infection. Expert Rev Mol Diagn. 2023 Jul-Dec;23(11):1011-1014. doi: 10.1080/14737159.2023.2260308. Epub 2023 Oct 24.

    PMID: 37724431DERIVED

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Comparison of SARS-CoV-2-RNA detectability in Swab and Salivette samples.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 23, 2020

Study Start

October 26, 2020

Primary Completion

January 20, 2021

Study Completion

January 20, 2021

Last Updated

July 26, 2021

Results First Posted

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

Locations

ME(1)