Household Study of COVID-19, Influenza and RSV Burden, Transmission Dynamics and Viral Interaction in South Africa

Summary

The study aims to characterize the community burden (including the clinical features) and transmissibility of SARS-CoV-2 within the context of a functional antibody response. In addition,the study will assess the effect of the interaction of SARS-CoV-2 with influenza virus and RSV on disease severity and transmission dynamics. A household-level prospective cohort study will be conducted in one rural and one urban community located in Mpumalanga Province and North West Province, respectively. The study will be conducted for 12 months of intensive follow up (July 2020 to August 2021) with a post-intensive follow-up continuing for a further 16 months (until December 2022). Two hundred households; 1,000 study participants of all ages; will be randomly selected from a list of 327 hoseholds that participated and successfully completed a 10-months follow-up period in a study similar to that currently proposed, but directed at community burden and transmission dynamics of influenza, respiratory syncytial virus and other respiratory pathogens. Each household and household member will be enumerated and the HIV infection status and the level of immunosuppression of HIV-infected individuals will be assessed. Each household member will be followed twice per week during the intense follow-up period (12 months) of the study. During this period upper respiratory tract samples will be collected irrespective of presence of symptoms and data on key symptoms, healthcare seeking, hospitalization and death will be captured at each follow up visit. Respiratory samples will be tested by reverse transcriptase real-time polymerase chain reaction (rRT-PCR) for SARS-CoV-2, influenza and RSV, and selected samples will be cultured and sequenced. An infection risk questionnaire will be administered to all study participants at enrollment and every month thereafter. Sera will be collected at enrollment and every 2 months during the 12-month intense follow-up period from all participants. In addition, sera will be collected every 2 months for a further 6 months following the 12-month intense follow-up period from study participants that tested positive for SARS-CoV-2 by rRT-PCR on respiratory specimens at 14, 16 and 18 months and from all study participants at 18 months. Sera will be tested for the presence of SARS-CoV-2, influenza and RSV antibodies. Wearable proximity sensors will be deployed for 8-12 days in each household over the 6-month intense follow-up period.

Conditions

• SARS-CoV-2 Infection
• Influenza
• Respiratory Syncytial Virus (RSV)

Sponsors & Collaborators

• National Institute for Communicable Diseases, South Africa

  lead OTHER

• Perinatal HIV Research Unit of the University of the Witswatersrand

  collaborator OTHER

• University of Witwatersrand, South Africa

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• Institute for Scientific Interchange, Torino, Italy

  collaborator UNKNOWN

• Fogarty International Center of the National Institute of Health

  collaborator NIH

Principal Investigators

• Kathleen Kahn, MD, PhD · MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Bushbuckridge, South Africa

• Neil Martinson, MD, PhD · Perinatal HIV Research Unit, Johannesburg

Eligibility

Min Age

0 Days

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-07-01

Primary Completion

2022-12-30

Completion

2022-12-31

Countries

• South Africa

Study Locations