Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique

COVID-19 Clinical Trial

— AfriCoVER  

Official title:

Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique Using Population-based (Sero)Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04442165
• Other study ID #: AfriCoVER
• Status: Completed
• Start date: December 15, 2020
• Est. completion date: March 29, 2022

Study information

• Verified date: October 2023
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A population-based COVID19 surveillance in a household cohort will be set-up using an existing Household demographic surveillance system (HDSS). From any individual in this population with any respiratory symptom or loss of smell or taste, with or without fever, investigators will collect a respiratory specimen and test these for SARS-CoV-2 virus, during 12 months. Demographic, epidemiological and clinical data of possible cases and of the source population will be recorded at baseline.

An age-stratified serial sero-survey will be conducted at baseline in a subset of the population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after confirmation of community transmission.

Description:

The investigators will use the established HDSS to set up population-based COVID19 surveillance in a household cohort. From any individual in this population with any respiratory symptom or loss of smell or taste, with or without fever, investigators will collect a respiratory specimen and test these for SARS-CoV-2 virus by PCR, during 12 months. These cases will be identified through bi-weekly household visits, through an alert system involving community leaders and HDSS interviewers, or when presenting with symptoms at healthcare centres or the referral hospital. Demographic, epidemiological and clinical data (comorbidities, medication, obesity, HIV, TB, smoking) of possible cases and of the source population will be recorded at baseline; recent illness, potential risk exposure of each household member (including duration and type) to SARS-CoV-2 positive individuals, uptake of measures to reduce exposure/transmission, and barriers to the uptake of such measures, will be recorded/updated during every household visit.

An age-stratified serial sero-survey will be conducted at baseline in a subset of the population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after confirmation of community transmission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15393
• Est. completion date: March 29, 2022
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any individual enrolled in the Polana Caniço-HDSS: All members residing in the household for at least 3 months (infants, children, adults, elderly), regardless of age, underlying conditions, medical history, infection or disease status or history

• Able and willing to provide written informed consent: by the household head for the surveillance; by each selected participant for the sero-survey.

No Exclusion Criteria

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Mozambique	INS	Maputo

Sponsors (5)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	European and Developing Countries Clinical Trials Partnership (EDCTP), Institut de Recherche pour le Developpement, Instituto Nacional de Saude, Mozambique, UMC Utrecht

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 disease incidence rate (symptomatic infections per month)	Estimate the COVID-19 incidence rate over a 12 month period in peri-urban Maputo	12 months
Primary	COVID-19 related hospitalization rate due to SARS-CoV-2	Estimate the hospitalization rate related to SARS-CoV-2 over a 12 month period in peri-urban Maputo	12 months
Primary	Case (disease) fatality risk (percent) due to SARS-CoV-2	Estimate the COVID-19 case fatality of cases detected during a 12 month period in peri-urban Maputo	12 months
Primary	Proportion asymptomatic infections, by age group	Estimate the proportion of infections that are asymptomatic, by age group	12 months
Primary	SARS-CoV-2 infection annual attack rate (percent)	Estimate the attack rate of SARS-CoV-2 infection during 12 months in peri-urban Maputo	12 months
Primary	SARS-CoV-2 infection fatality risk	Estimate the SARS-CoV-2 infection fatality of infections detected during a 12 month period in peri-urban Maputo	12 months
Primary	Infection fatality of SARS-CoV-2 infection.	Estimate the infection fatality of SARS-CoV-2 infection in peri-urban Maputo.	12 months
Primary	Serial interval number of SARS-CoV-2 infection	Estimate the serial interval number of SARS-CoV-2 infection in peri-urban Maputo.	12 months
Primary	Reproduction number of SARS-CoV-2 infection	Estimate the reproduction number of SARS-CoV-2 infection in peri-urban Maputo.	12 months
Secondary	Correlation between anti-coronavirus (endemic coronavirus or SARS-CoV-2) antibody titers and reinfection	Analyze the correlation between anti-coronavirus (endemic coronavirus or SARS-CoV-2) antibody titers and reinfection	12 months
Secondary	Antibody titers against SARS-CoV-2 over time	Measure antibody titers against SARS-CoV-2 over time	12 months