Covid19TRACENCT05119348
Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments
A study testing STOPCOV in people with Covid19 and Sars-CoV-2 Infection, run by Desmond Tutu HIV Foundation at 1 site in South Africa.
Trial summary
South Africa recorded it's first coronavirus disease 2019 (COVID19) case on March 5, 2020. In response to the COVID19 outbreak World Health Organisation recommendations, South Africa implemented non-pharmaceutical recommendations. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Sars-CoV-2 Infection
- What is being tested?
- STOPCOV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteSouth Africa
- Study dates
- 14 Sep 2020to 21 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- recently diagnosed SARS-CoV-2 positive
- Individual >12 years
- Able to give assent if <18 years with parental/guardian consent
- Able to give consent> 18 years
- Self-isolating at home at the time of COVID diagnosis
Who cannot join
- <12 years
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transmission of COVID19 in Crowded Environments
South Africa recorded it's first coronavirus disease 2019 (COVID19) case on March 5, 2020. In response to the COVID19 outbreak World Health Organisation recommendations, South Africa implemented non-pharmaceutical recommendations. The major risk mitigation factors recommended by World Health Organisation and others - physical distancing and hygiene - are extremely difficult to implement in much of Africa. The investigators will conduct a randomised controlled trial to investigate the effect of an infection mitigation intervention to assess the effect on household transmission of severe acute respiratory syndrome (SARS) coronavirus (CoV) 2 in household settings with an index patient diagnosed SARS-CoV-2 positive.
Read the detailed description
The major risk mitigation factors recommended by World Health Organisation and others - physical distancing and hygiene - are extremely difficult to implement in much of Africa. Newly diagnosed SARS-CoV-2 index patients will be identified and recruited from a mobile clinic and local community clinics conducting SARS-CoV-2 testing. Index cases and their households will be invited to enroll. The study design is a type 2 hybrid cluster (household) randomised controlled trial, with outcomes assessed on index patients and their household contacts. 120 consecutively newly diagnosed index patients (GeneXpert severe acute respiratory syndrome coronavirus 2 PCR) and up to 6- 8 household contacts will be invited to participate in the trial as part of the prospective observational study evaluating transmission and symptoms. After completing consent, households will be randomised in a 1:1 ratio in blocks of 10 (60 households per group). Klipfontein is a resource-limited, densely populated, high HIV/tuberculosis disease burden areas in Cape Town. Newly diagnosed COVID19 cases will be identified from two sources: screening conducted in Desmond Tutu Health Foundation mobile screening units and local public sector clinics working closely with Desmond Tutu Health Foundation. Consecutive cases (n=120 cases and households) will be invited to participate in the randomised trial and prospective longitudinal follow up of up to 6- 8 household contacts. The contacts will be followed up after informed consent to SARS-CoV-2 screening, symptomatic questionnaires weekly up to 1 month. After enrolment, the household will be randomised to the infection mitigation intervention or enhanced usual care messaging. Baseline demographic, household characteristics questionnaire will be administered, and each household occupant invited to participate. Following consent procedures, household contacts (HHC) will be screened at baseline and weekly for 4 weeks for evidence of COVID19 infection. Specifically, the research team will conduct SARS-CoV-2 GeneXpert PCR testing and antibody serology. They will collate self- administered daily symptom checks on a weekly basis. The investigators will recruit 120 households over 1-11 months. The investigators will initiate a prospective longitudinal follow up of the household contacts of each case for 4 weeks in each case.
The investigators will calculate proportion of SARS-CoV-2 transmission from index cases in each household over 4- week period and describe the proportion of symptomatic and asymptomatic SARS-CoV-2 infection in a high density, low resourced community. Investigate the impact of the infection mitigation intervention by comparing incidence in households randomised to intervention versus standard of care. Secondary outcomes for the trial will include clinical outcomes (hospitalisations, death), linkages to care for people, psychosocial functioning, and stigma.
- Conditions
- Covid19, Sars-CoV-2 Infection
- Being tested
- STOPCOV
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOPCOVOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stop coronavirus (STOPCOV) | Experimental | 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. Receives: Other: STOPCOV |
| Control | No intervention | Participants received no additional messaging about managing COVID19 in the household. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 Infection
Number of participants with positive SARS-CoV-2 PCR result
Measured: 4 weeks
Secondary outcomes (1)
COVID19 Symptoms
Number of participants with SARS-CoV-2 serology antibody positive result
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start14 Sep 2020
- Primary completion4 Aug 2021
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a type 2 hybrid cluster (household) randomised controlled trial, with outcomes assessed on index patients and their household contacts. After completing consent, 120 households will be randomised in a 1:1 ratio (60 per arm).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desmond Tutu HIV Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam Institute for Global Health and Development, European and Developing Countries Clinical Trials Partnership (EDCTP), University of Cape Town
- Responsible party
- Sponsor
- Investigators
- Linda-Gail Bekker, MBChB, PhD, Principal investigator, Desmond Tutu Health Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119348
- Sponsor's protocol ID
- HREC 284 2020
- Acronym
- TRACE
- Status last verified
- Aug 2024
- First submitted
- 12 Nov 2021
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data with other researchers.
Publications
Smith P, Little F, Hermans S, Davies MA, Wood R, Orrell C, Pike C, Peters F, Dube A, Georgeu-Pepper D, Curran R, Fairall L, Bekker LG. A prospective randomised controlled trial investigating household SARS-CoV-2 transmission in a densely populated community in Cape Town, South Africa - the transmission of COVID-19 in crowded environments (TRACE) study. BMC Public Health. 2024 Jul 17;24(1):1924. doi: 10.1186/s12889-024-19462-1.
PubMed 39020307
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmission of COVID19 in Crowded Environments
- ClinicalTrials.gov ID
- NCT05119348
- Acronym / sponsor ID
- TRACE / HREC 284 2020
- Conditions
- Covid19, Sars-CoV-2 Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Desmond Tutu HIV FoundationUniversity, hospital or other
- Collaborators
- Amsterdam Institute for Global Health and Development, European and Developing Countries Clinical Trials Partnership (EDCTP), University of Cape Town
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
South Africa recorded it's first coronavirus disease 2019 (COVID19) case on March 5, 2020. In response to the COVID19 outbreak World Health Organisation recommendations, South Africa implemented non-pharmaceutical recommendations. The major risk mitigation factors recommended by World Health Organisation and others - physical distancing and hygiene - are extremely difficult to implement in much of Africa. The investigators will conduct a randomised controlled trial to investigate the effect of an infection mitigation intervention to assess the effect on household transmission of severe acute respiratory syndrome (SARS) coronavirus (CoV) 2 in household settings with an index patient diagnosed SARS-CoV-2 positive.
Detailed description
The major risk mitigation factors recommended by World Health Organisation and others - physical distancing and hygiene - are extremely difficult to implement in much of Africa. Newly diagnosed SARS-CoV-2 index patients will be identified and recruited from a mobile clinic and local community clinics conducting SARS-CoV-2 testing. Index cases and their households will be invited to enroll. The study design is a type 2 hybrid cluster (household) randomised controlled trial, with outcomes assessed on index patients and their household contacts. 120 consecutively newly diagnosed index patients (GeneXpert severe acute respiratory syndrome coronavirus 2 PCR) and up to 6- 8 household contacts will be invited to participate in the trial as part of the prospective observational study evaluating transmission and symptoms. After completing consent, households will be randomised in a 1:1 ratio in blocks of 10 (60 households per group). Klipfontein is a resource-limited, densely populated, high HIV/tuberculosis disease burden areas in Cape Town. Newly diagnosed COVID19 cases will be identified from two sources: screening conducted in Desmond Tutu Health Foundation mobile screening units and local public sector clinics working closely with Desmond Tutu Health Foundation. Consecutive cases (n=120 cases and households) will be invited to participate in the randomised trial and prospective longitudinal follow up of up to 6- 8 household contacts. The contacts will be followed up after informed consent to SARS-CoV-2 screening, symptomatic questionnaires weekly up to 1 month. After enrolment, the household will be randomised to the infection mitigation intervention or enhanced usual care messaging. Baseline demographic, household characteristics questionnaire will be administered, and each household occupant invited to participate. Following consent procedures, household contacts (HHC) will be screened at baseline and weekly for 4 weeks for evidence of COVID19 infection. Specifically, the research team will conduct SARS-CoV-2 GeneXpert PCR testing and antibody serology. They will collate self- administered daily symptom checks on a weekly basis. The investigators will recruit 120 households over 1-11 months. The investigators will initiate a prospective longitudinal follow up of the household contacts of each case for 4 weeks in each case.
The investigators will calculate proportion of SARS-CoV-2 transmission from index cases in each household over 4- week period and describe the proportion of symptomatic and asymptomatic SARS-CoV-2 infection in a high density, low resourced community. Investigate the impact of the infection mitigation intervention by comparing incidence in households randomised to intervention versus standard of care. Secondary outcomes for the trial will include clinical outcomes (hospitalisations, death), linkages to care for people, psychosocial functioning, and stigma.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study design is a type 2 hybrid cluster (household) randomised controlled trial, with outcomes assessed on index patients and their household contacts. After completing consent, 120 households will be randomised in a 1:1 ratio (60 per arm).
| Arm | Type | Receives |
|---|---|---|
| Stop coronavirus (STOPCOV) | Experimental | Other: STOPCOVA fieldworker will deliver the STOPCOV pack and personal protective equipment at baseline. The fieldworker will communicate with intervention households daily, delivering STOPCOV hygiene information. |
| Control | No intervention | –Participants received no additional messaging about managing COVID19 in the household. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- recently diagnosed SARS-CoV-2 positive
- Individual >12 years
- Able to give assent if <18 years with parental/guardian consent
- Able to give consent> 18 years
- Self-isolating at home at the time of COVID diagnosis
Key exclusion criteria (2 listed)
- <12 years
- Unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STOPCOVFieldworkers 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. | Other | Stop coronavirus (STOPCOV) |
Primary outcome
SARS-CoV-2 Infection
Time frame: 4 weeks
Number of participants with positive SARS-CoV-2 PCR result
1 secondary outcome
COVID19 Symptoms
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39020307Smith P, Little F, Hermans S, Davies MA, Wood R, Orrell C, Pike C, Peters F, Dube A, Georgeu-Pepper D, Curran R, Fairall L, Bekker LG. A prospective randomised controlled trial investigating household SARS-CoV-2 transmission in a densely populated community in Cape Town, South Africa - the transmission of COVID-19 in crowded environments (TRACE) study. BMC Public Health. 2024 Jul 17;24(1):1924. doi: 10.1186/s12889-024-19462-1.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda-Gail Bekker, MBChB, PhD principal investigator
Desmond Tutu Health Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STOPCOV in people with Covid19 and Sars-CoV-2 Infection, run by Desmond Tutu HIV Foundation at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 Infection (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05119348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.