N/A
N=151
COVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR
Covid-19
Bottom Line
View on ClinicalTrials.gov: NCT04599959 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico — 85; 13; 66; 89 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico |
85; 13; 66; 89; 0; 1 | — |
| PRIMARY Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany |
52.2; 100.0 | — |
Summary
The main objective of the tests is to establish saliva collection with Salivette® Cortisol.
Eligibility Criteria
Inclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04599959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.