Trial Outcomes & Findings for Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic Patients. (NCT NCT04799704)
NCT ID: NCT04799704
Last Updated: 2025-01-24
Results Overview
Bilateral conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia at least once.
TERMINATED
30 participants
during hospitalization every 3 days until the day of discharge up to 1 month
2025-01-24
Participant Flow
Conjunctival sampling will take place every three days until the day of hospital discharge.
Unit of analysis: swabs
Participant milestones
| Measure |
Symptomatic Patient
The first part of our study is to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.
swabbing of conjunctiva: Each eye will be sampled with a single, sterile, nylon, flocked swab
|
|---|---|
|
Overall Study
STARTED
|
30 176
|
|
Overall Study
COMPLETED
|
30 176
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Symptomatic Patient
n=30 Participants
The first part of our study is to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.
swabbing of conjunctiva: Each eye will be sampled with a single, sterile, nylon, flocked swab
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=30 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 16 • n=30 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=30 Participants
|
|
Region of Enrollment
Belgium
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: during hospitalization every 3 days until the day of discharge up to 1 monthPopulation: symptomatic patients admitted at our University Hospital Leuven, Belgium with a positive nasopharyngeal swab for SARS-nCoV-2
Bilateral conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia at least once.
Outcome measures
| Measure |
Symptomatic Patient
n=176 swabs
The first part of our study is to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.
swabbing of conjunctiva: Each eye will be sampled with a single, sterile, nylon, flocked swab
|
|---|---|
|
The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients.
positive SARS-CoV-2 swab
|
13 swabs
|
|
The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients.
strongly positive SARS-CoV-2
|
3 swabs
|
|
The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients.
weakly positive SARS-CoV-2
|
10 swabs
|
Adverse Events
Symptomatic Patient
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place