Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments

NCT05119348 | Completed Results

• 1 other identifier: HREC 284 2020
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Sars-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 Infection

  Number of participants with positive SARS-CoV-2 PCR result

  4 weeks

Secondary Outcomes (1)

• COVID19 Symptoms

  4 weeks

Study Arms (2)

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.

Other: STOPCOV

Control

NO INTERVENTION

Participants received no additional messaging about managing COVID19 in the household.

Interventions

STOPCOV OTHER

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.

Stop coronavirus (STOPCOV)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<12 years
• Unable to give consent

Sponsors & Collaborators

• Desmond Tutu HIV Foundation: lead
• Amsterdam Institute for Global Health and Development: collaborator
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• University of Cape Town: collaborator

Study Sites (1)

Desmond Tutu Health Foundation

Cape Town, WC, 7925, South Africa

Location

Related Publications (1)

• 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.

  PMID: 39020307 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Philip Smith
• Organization: Desmond Tutu Health Foundation

Philip.Smith@hiv-research.org.za

+27216501895

Study Officials

• Linda-Gail Bekker, MBChB, PhD

  Desmond Tutu Health Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators were not made aware of participants study condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 15, 2021
• Study Start: September 14, 2020
• Primary Completion: August 4, 2021
• Study Completion: October 21, 2021
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)