Understanding COVID-19 Infections in Pregnant Women and Their Babies in 5 African Nations (periCOVID Africa)

Covid19 Clinical Trial

Official title:

Understanding COVID-19 Infections in Pregnant Women and Their Babies in Uganda, Kenya, Malawi, the Gambia and Mozambique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05409274
• Other study ID #: 13487-10
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Develop coronavirus disease 2019 (COVID-19) surveillance in pregnancy in The Gambia, Kenya, Malawi, Mozambique and Uganda

Estimate the seroepidemiology of COVID-19 infection among pregnant women in these countries

Define the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant women and their babies and determine the presence of antibodies in cord blood

Work with communities to develop understanding of infection prevention and control techniques to reduce the spread of COVID-19 amongst the pregnant population

Description:

This study has been set up as part of the response to the international outbreak of the novel Severe acute respiratory syndrome coronavirus 2 (SARS CoV-2). The aim of the study is to answer important questions about the impact of the novel coronavirus on pregnant women and their infants. The investigators aim to describe the sero-epidemiology and burden of COVID-19 disease among pregnant women, as well as the impact on maternal and neonatal health, by collecting epidemiological data and by collecting samples during pregnancy, labour and delivery and in the neonatal period.

Data from this study will be pooled from 5 countries; Malawi, Uganda, Mozambique, the Gambia, and Kenya to provide robust and generalisable evidence from the different regions in sub-Saharan Africa. the investigators hope that with this information, they can contribute to the evidence base for recommendations, guidance and policy decisions for the clinical management and public health response to protect pregnant women and their infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6635
• Est. completion date: December 31, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Any pregnant woman or emancipated minor at any gestation, up to and including day of delivery. Individual study sites may have their own specific inclusion/exclusion criteria which is not listed here.

• Accepts to read or to be read to and sign or fingerprint the approved study consent form

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Pregnancy Related

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
Gambia	MRC Unit The Gambia at LSHTM	Fajara
Kenya	Aga Khan University	Nairobi
Malawi	University of Malawi	Zomba
Mozambique	Fundação Manhiça	Manhiça
Uganda	MRC/UVRI	Entebbe

Sponsors (10)

Lead Sponsor	Collaborator
St George's, University of London	Aga Khan University, Fundação Manhiça, King's College London, London School of Hygiene and Tropical Medicine, Makerere University, MU-JHU CARE, University of Bergen, University of Liverpool, University of Malawi

Countries where clinical trial is conducted

Gambia,  Kenya,  Malawi,  Mozambique,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the seroepidemiology of SARS-CoV-2 infection among African pregnant women from 5 African countries across several waves of the COVID-19 pandemic in those countries.	The proportion of individuals who show seropositivity for SARS-CoV-2 virus. If data is collected, sero-prevalence by different groups (e.g. geography, profession, residence) will be an important sub-analysis.	through study completion, an average of 1 year
Secondary	To define the impact of SARS-CoV-2 infection in pregnancy adjusted for key pregnancy and neonatal outcomes as defined by the Global Alignment of Immunization safety Assessment in pregnancy (GAIA) criteria	SARS-CoV-2 positive status (by serology or by clinical signs or symptoms of COVID-19 illness which meets the World Health Organisation (WHO) case definition for probable or confirmed SARS-CoV-2 illness).	through study completion, an average of 1 year
Secondary	Estimate the fraction of asymptomatic or pre-symptomatic/ subclinical infections in the population of pregnant women sampled.	Asymptomatic fraction (proportion of cases that are asymptomatic). The proportion of individuals who reported no symptoms of COVID-19 infection out of individuals seropositive for SARS-CoV-2.	through study completion, an average of 1 year