Trial Outcomes & Findings for COVID-19 SARS-CoV-2 Screening Protocol (NCT NCT04740320)
NCT ID: NCT04740320
Last Updated: 2024-08-13
Results Overview
Number of participants enrolled in main study
Recruitment status
COMPLETED
Target enrollment
36 participants
Primary outcome timeframe
6 months
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
Healthy Volunteers
Volunteers asked to register details on a SARS-CoV-2 specific web page UKcovidchallenge.com. They will be contacted with a short webform questionnaire to be performed prior to a follow-up telephone questionnaire or will be asked to complete a telephone questionnaire. If inclusion/exclusion criteria are met, appointment for a screening visit will be scheduled. Screening appointments will be conducted at hVIVO. Written consent for screening will be obtained prior to any history-taking, examination or tests are carried out. Medical history will be requested from GP to assess suitability. Once the SARS-CoV-2 characterization study is approved, potential participants will be given the study specific PIS detailing the full study and experimental procedures. The opportunity to discuss further and ask questions will be available prior to booking a study visit.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
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
| Measure |
Healthy Volunteers
n=36 Participants
Volunteers asked to register details on a SARS-CoV-2 specific web page UKcovidchallenge.com. They will be contacted with a short webform questionnaire to be performed prior to a follow-up telephone questionnaire or will be asked to complete a telephone questionnaire. If inclusion/exclusion criteria are met, appointment for a screening visit will be scheduled. Screening appointments will be conducted at hVIVO. Written consent for screening will be obtained prior to any history-taking, examination or tests are carried out. Medical history will be requested from GP to assess suitability. Once the SARS-CoV-2 characterization study is approved, potential participants will be given the study specific PIS detailing the full study and experimental procedures. The opportunity to discuss further and ask questions will be available prior to booking a study visit.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
21.8 age of participants
STANDARD_DEVIATION 2.69 • n=36 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=36 Participants
|
|
Region of Enrollment
United Kingdom
|
36 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of participants enrolled in main study
Outcome measures
| Measure |
Healthy Volunteers
n=36 Participants
Volunteers asked to register details on a SARS-CoV-2 specific web page UKcovidchallenge.com. They will be contacted with a short webform questionnaire to be performed prior to a follow-up telephone questionnaire or will be asked to complete a telephone questionnaire. If inclusion/exclusion criteria are met, appointment for a screening visit will be scheduled. Screening appointments will be conducted at hVIVO. Written consent for screening will be obtained prior to any history-taking, examination or tests are carried out. Medical history will be requested from GP to assess suitability. Once the SARS-CoV-2 characterization study is approved, potential participants will be given the study specific PIS detailing the full study and experimental procedures. The opportunity to discuss further and ask questions will be available prior to booking a study visit.
|
|---|---|
|
Participants Enrolled
|
36 Participants
|
Adverse Events
Healthy Volunteers
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place