Prospective COVID-19 Cohort Study, Dominican Republic

NCT ID: NCT04898738

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1043 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-18

Study Completion Date

2023-02-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This project will build on an existing CDC funded cooperative agreement in the Dominican Republic with the Brigham and Women's Hospital (2018-2023) that includes (i) prospective COVID-19 and AFI surveillance at two health facilities and (ii) a nationally representative cross-sectional community-based serological survey of approximately 7,000 healthy adults and children targeting SARS-CoV-2 and other AFI pathogens to be conducted between April and June 2021. This linked study will establish a nested cohort of 2,000 participants enrolled in the national serological survey and prospectively monitor them for COVID-19 symptoms, conduct serial serological testing, implement molecular surveillance for SARS-CoV-2 and sequencing for variants of concern, implement and evaluate WASH mitigation measures, and monitor uptake and perceptions of COVID-19 vaccines.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV-2 Infection Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective cohort study that aims to prospectively monitor 2,000 community-based study participants with serial serological screening for SARS-CoV-2 and enhanced molecular surveillance for active infection. Nested within this cohort is a randomized trial that will allocate study participants into two arms: thoe that receive versus do not receive alcohol-based hand sanitizer (ABHS) through the course of the study.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alcohol-based hand sanitizer

Half the study households with receive ABHS through the course of the study

Group Type ACTIVE_COMPARATOR

Alcohol based hand sanitizer

Intervention Type OTHER

Provision of ABHS to randomly selected households

No Alcohol-based hand sanitizer

Half the study households with not receive ABHS through the course of the study

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alcohol based hand sanitizer

Provision of ABHS to randomly selected households

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Previously enrolled in a linked national community-based seroepidemiological study in the Dominican Republic
* Agreed and consented to be recontacted to participate in additional research studies at the time of enrollment in #1
* ≥2 years of age
* Agree to participate

Exclusion Criteria

* Ward of the State
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

The University of Queensland

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Broad Institute of MIT and Harvard

OTHER

Sponsor Role collaborator

Ministerio de Salud Publica y Asistencia Social, Republica Dominicana

OTHER_GOV

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eric J. Nilles, M.D.,M.S.C.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eric J Nilles, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Community study

Santo Domingo, , Dominican Republic

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Dominican Republic

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021p001294

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preop COVID Testing Patterns
NCT04838119 COMPLETED