SARS-CoV-2 InfectionNCT04898738
Prospective COVID-19 Cohort Study, Dominican Republic
A study testing Alcohol based hand sanitizer in people with SARS-CoV-2 Infection and Covid19, run by Brigham and Women's Hospital at 1 site in Dominican Republic.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, Covid19
- What is being tested?
- Alcohol based hand sanitizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,043 participants
- Where
- 1 siteDominican Republic
- Study dates
- 18 Aug 2021to 10 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Ward of the State
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective COVID-19 Cohort Study to Assess the Epidemiology, Transmission and Control of SARS-CoV-2 in the Dominican Republic
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.
- Conditions
- SARS-CoV-2 Infection, Covid19
- Being tested
- Alcohol based hand sanitizer
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol based hand sanitizerOther
Provision of ABHS to randomly selected households
| Study group | Role | What they receive |
|---|---|---|
| Alcohol-based hand sanitizer | Active comparator | Half the study households with receive ABHS through the course of the study Receives: Other: Alcohol based hand sanitizer |
| No Alcohol-based hand sanitizer | No intervention | Half the study households with not receive ABHS through the course of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand hygiene practices
The average daily frequency of study participant hand hygiene events over the previous seven days will be assessed using standardized survey questionnaires at 0-, 3-, 6-, 9-, and 12-months.
Measured: 1 year
Secondary outcomes (2)
Acceptability of hand hygiene technology
Study participants preference for different hand hygiene technology (e.g. soap and water, ABHR) as measured using a five-point Likert Scale at 0-, 3-, 6-, 9-, and 12-months.
Measured: 1 year
SARS-Cov-2 seroconversion
Number of study participants that seroconvert from SARS-CoV-2 seronegative to seropositive at time points 0-, 6-, and 12-months as assessed by presence of anti-nucleocapsid immunoglobulin
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start18 Aug 2021
- Primary completion22 Nov 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,043 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, London School of Hygiene and Tropical Medicine, The University of Queensland, Yale University, Broad Institute of MIT and Harvard, Ministerio de Salud Publica y Asistencia Social, Republica Dominicana
- Responsible party
- Principal investigator, Eric J. Nilles, M.D.,M.S.C., Brigham and Women's Hospital
- Investigators
- Eric J Nilles, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898738
- Sponsor's protocol ID
- 2021p001294
- Status last verified
- Nov 2025
- First submitted
- 19 May 2021
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data for epidemiological analyses and modelling (including demographic data, clinical data, and survey questionnaire survey) will be shared with the following collaborators: Adam Kucharski (LSHTM), Colleen Lau (University of Queensland), Marietta Vasquez (Yale University), Matt Lozier (US CDC), Pardis Sabeti (Broad Institute), and staff at the Health Ministry Division of Epidemiology. Non-identifiable data shared with listed collaborators will be performed with secure file transfer.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective COVID-19 Cohort Study to Assess the Epidemiology, Transmission and Control of SARS-CoV-2 in the Dominican Republic
- ClinicalTrials.gov ID
- NCT04898738
- Acronym / sponsor ID
- 2021p001294
- Conditions
- SARS-CoV-2 Infection, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,043 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, London School of Hygiene and Tropical Medicine, The University of Queensland, Yale University, Broad Institute of MIT and Harvard, Ministerio de Salud Publica y Asistencia Social, Republica Dominicana
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alcohol-based hand sanitizer | Active comparator | Other: Alcohol based hand sanitizerHalf the study households with receive ABHS through the course of the study |
| No Alcohol-based hand sanitizer | No intervention | –Half the study households with not receive ABHS through the course of the study |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Ward of the State
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol based hand sanitizerProvision of ABHS to randomly selected households | Other | Alcohol-based hand sanitizer |
Primary outcome
Hand hygiene practices
Time frame: 1 year
The average daily frequency of study participant hand hygiene events over the previous seven days will be assessed using standardized survey questionnaires at 0-, 3-, 6-, 9-, and 12-months.
2 secondary outcomes
Acceptability of hand hygiene technology
Time frame: 1 year
SARS-Cov-2 seroconversion
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified data for epidemiological analyses and modelling (including demographic data, clinical data, and survey questionnaire survey) will be shared with the following collaborators: Adam Kucharski (LSHTM), Colleen Lau (University of Queensland), Marietta Vasquez (Yale University), Matt Lozier (US CDC), Pardis Sabeti (Broad Institute), and staff at the Health Ministry Division of Epidemiology. Non-identifiable data shared with listed collaborators will be performed with secure file transfer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Nilles, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol based hand sanitizer in people with SARS-CoV-2 Infection and Covid19, run by Brigham and Women's Hospital at 1 site in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand hygiene practices (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.