Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments

Covid19 Clinical Trial

— TRACE  

Official title:

Transmission of COVID19 in Crowded Environments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119348
• Other study ID #: HREC 284 2020
• Status: Completed
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: October 21, 2021

Study information

• Verified date: April 2022
• Source: Desmond Tutu HIV Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 21, 2021
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• <12 years

• Unable to give consent

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Sars-CoV-2 Infection

Intervention

Other:
• 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.

Locations

Country	Name	City	State
South Africa	Desmond Tutu Health Foundation	Cape Town	WC

Sponsors (4)

Lead Sponsor	Collaborator
Desmond Tutu HIV Foundation	Amsterdam Institute for Global Health and Development, European and Developing Countries Clinical Trials Partnership (EDCTP), University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 infection	Proportion of participants with severe acute respiratory syndrome coronavirus 2 infection	4 weeks
Secondary	COVID19 symptoms	Proportion of participants with of COVID19 symptoms	4 weeks