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Trial record 2 of 12 for:    covid | Boehringer

COVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04599959
Recruitment Status : Completed
First Posted : October 23, 2020
Results First Posted : July 26, 2021
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Covid-19 Diagnostic Test: Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Comparison of SARS-CoV-2-RNA detectability in Swab and Salivette samples.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: COVID-19 Tests: a Systematic Comparison of Viral RNA Test Sample Taking for RT-qPCR, in This Case With a Nasopharyngeal Swab or Saliva Collected With Salivette® Cortisol, to Diagnose SARS-CoV-2 Virus Infection
Actual Study Start Date : October 26, 2020
Actual Primary Completion Date : January 20, 2021
Actual Study Completion Date : January 20, 2021


Arm Intervention/treatment
Experimental: Overall (Swab/Saliva) Diagnostic Test: Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol
Kylt® for detection/confirmation of SARS-CoV-2 cobas® SARS-CoV-2 (PCR) test TaqPath™ COVID-19 CE-IVD RT-PCR kit




Primary Outcome Measures :
  1. Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico [ Time Frame: At baseline (the test day), up to one day. ]
    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.

  2. Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany [ Time Frame: 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 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".



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04599959


Locations
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Mexico
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Mexico, Mexico, 14080
Sponsors and Collaborators
Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04599959    
Other Study ID Numbers: 0352-2150
First Posted: October 23, 2020    Key Record Dates
Results First Posted: July 26, 2021
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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/


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Hydrocortisone
Anti-Inflammatory Agents