Trial Outcomes & Findings for Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments (NCT NCT05119348)
NCT ID: NCT05119348
Last Updated: 2024-08-09
Results Overview
Number of participants with positive SARS-CoV-2 PCR result
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
245 participants
Primary outcome timeframe
4 weeks
Results posted on
2024-08-09
Participant Flow
Participant milestones
| Measure |
Stop Coronavirus (STOPCOV)
A fieldworker will deliver the STOPCOV pack and personal protective equipment at baseline. The fieldworker will communicate with intervention households daily, delivering STOPCOV hygiene information.
STOPCOV: Fieldworkers delivered an infection mitigation intervention which consisted of personal protective equipment and messaging on managing COVID19 and reducing onward transmission of SARS-CoV-2 infection.
|
Control
Participants received no additional messaging about managing COVID19 in the household.
|
|---|---|---|
|
Overall Study
STARTED
|
137
|
108
|
|
Overall Study
COMPLETED
|
137
|
108
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments
Baseline characteristics by cohort
| Measure |
Stop Coronavirus (STOPCOV)
n=137 Participants
A fieldworker will deliver the STOPCOV pack and personal protective equipment at baseline. The fieldworker will communicate with intervention households daily, delivering STOPCOV hygiene information.
STOPCOV: Fieldworkers delivered an infection mitigation intervention which consisted of personal protective equipment and messaging on managing COVID19 and reducing onward transmission of SARS-CoV-2 infection.
|
Control
n=108 Participants
Participants received no additional messaging about managing COVID19 in the household.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 16.6 • n=99 Participants
|
39.9 years
STANDARD_DEVIATION 17.1 • n=107 Participants
|
39.1 years
STANDARD_DEVIATION 16.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
69 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Coloured
|
68 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Indian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Prefer not to say
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
137 participants
n=99 Participants
|
108 participants
n=107 Participants
|
245 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Number of participants where there was a change observed in their negative to a positive SARS-CoV-2 PCR result
Number of participants with positive SARS-CoV-2 PCR result
Outcome measures
| Measure |
Stop Coronavirus (STOPCOV)
n=137 Participants
A fieldworker will deliver the STOPCOV pack and personal protective equipment at baseline. The fieldworker will communicate with intervention households daily, delivering STOPCOV hygiene information.
STOPCOV: Fieldworkers delivered an infection mitigation intervention which consisted of personal protective equipment and messaging on managing COVID19 and reducing onward transmission of SARS-CoV-2 infection.
|
Control
n=108 Participants
Participants received no additional messaging about managing COVID19 in the household.
|
|---|---|---|
|
SARS-CoV-2 Infection
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Number of participants where there was a change observed in their negative to a positive SARS-CoV-2 serology result
Number of participants with SARS-CoV-2 serology antibody positive result
Outcome measures
| Measure |
Stop Coronavirus (STOPCOV)
n=137 Participants
A fieldworker will deliver the STOPCOV pack and personal protective equipment at baseline. The fieldworker will communicate with intervention households daily, delivering STOPCOV hygiene information.
STOPCOV: Fieldworkers delivered an infection mitigation intervention which consisted of personal protective equipment and messaging on managing COVID19 and reducing onward transmission of SARS-CoV-2 infection.
|
Control
n=108 Participants
Participants received no additional messaging about managing COVID19 in the household.
|
|---|---|---|
|
COVID19 Symptoms
|
11 Participants
|
9 Participants
|
Adverse Events
Stop Coronavirus (STOPCOV)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stop Coronavirus (STOPCOV)
n=137 participants at risk
A fieldworker will deliver the STOPCOV pack and personal protective equipment at baseline. The fieldworker will communicate with intervention households daily, delivering STOPCOV hygiene information.
STOPCOV: Fieldworkers delivered an infection mitigation intervention which consisted of personal protective equipment and messaging on managing COVID19 and reducing onward transmission of SARS-CoV-2 infection.
|
Control
n=108 participants at risk
Participants received no additional messaging about managing COVID19 in the household.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
4.4%
6/137 • 4 weeks
|
0.93%
1/108 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pressure in chest
|
5.1%
7/137 • 4 weeks
|
1.9%
2/108 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Somnolence/ drowsy/ sleepy
|
1.5%
2/137 • 4 weeks
|
0.00%
0/108 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Confused/ disoriented
|
0.00%
0/137 • 4 weeks
|
0.93%
1/108 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place