Trial Outcomes & Findings for COVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR (NCT NCT04599959)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

151 participants

Primary outcome timeframe

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

Results posted on

2021-07-26

Participant Flow

This study compared the viral Ribonucleic acid (RNA) test sample taken for Quantitative reverse transcription polymerase chain reaction (RT-qPCR) via a nasopharyngeal swab versus saliva collected with Salivette® Cortisol in the diagnosing of SARS-CoV-2 virus infection.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.

Participant milestones

Participant milestones
Measure	Overall All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry. Two samples were taken by medical staff from each participant on the test day, one using a swab (oropharyngeal swab) and the other through saliva collected with Salivette® Cortisol. The collected samples were then shipped and analyzed in Germany. Additional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico.
Overall Study STARTED	151
Overall Study COMPLETED	151
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=151 Participants All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry. Two samples were taken by medical staff from each participant on the test day, one using a swab (oropharyngeal swab) and the other through saliva collected with Salivette® Cortisol. The collected samples were then shipped and analyzed in Germany. Additional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico.
Age, Continuous	43.4 Years STANDARD_DEVIATION 14.68 • n=151 Participants
Sex: Female, Male Female	80 Participants n=151 Participants
Sex: Female, Male Male	71 Participants n=151 Participants

PRIMARY outcome

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

Population: All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry, and whose samples were 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.

Outcome measures

Outcome measures
Measure	Swab - Processed in Mexico n=151 Participants All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry. Additional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico. Participants whose swab samples were processed in Mexico and had non-missing results were included in this group.	Saliva - Processed in Mexico n=103 Participants All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry. Additional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico. Participants whose saliva samples collected via Salivette® Cortisol were processed in Mexico and had non-missing results were included in this group.
Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico Positive	85 Participants	13 Participants
Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico Negative	66 Participants	89 Participants
Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico Ambiguous	0 Participants	1 Participants

PRIMARY outcome

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

Population: All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry, and had both swab and saliva sample that were 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".

Outcome measures

Outcome measures
Measure	Swab - Processed in Mexico n=141 Participants All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry. Additional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico. Participants whose swab samples were processed in Mexico and had non-missing results were included in this group.	Saliva - Processed in Mexico All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry. Additional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico. Participants whose saliva samples collected via Salivette® Cortisol were processed in Mexico and had non-missing results were included in this group.
Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany True positive (sensitivity)	52.2 Percentage of participants	—
Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany True negative (specificity)	100.0 Percentage of participants	—

Adverse Events

Overall

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER