Healthy VolunteersNCT04594395
Defining the COVID-19 Immunity Denominator in the Mekong: a Cross-Sectional Seroprevalence Study of SARS-CoV-2 in HealthyVolunteers
An observational study of Healthy Volunteers, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Cambodia.
Trial summary
Background: In early 2020, many people thought Cambodia would have a serious COVID-19 outbreak due to the high number of Chinese travelers going to Cambodia. But as of June 14, 2020, only 128 cases of COVID-19 have been identified in the country. Many of these cases have been from people who had traveled in Europe. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 0 participants
- Where
- 2 sitesCambodia
- Study dates
- 24 Sep 2021to 30 Sep 2021
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Advertising and recruitment in this province will mainly be via word of mouth using health staff and the local village chiefs to communicate to the general public when and where the mobile unit will be sampling. Large signs and banners will be made to hang wherever the mobile unit set up in the designated area. We anticipate having to screen no more than 2,500 individuals per year to enroll our target of 2,000 participants per year over the next 3 years. We have no pre-set male:female ratios or age structures. We do plan to sample many different small clusters from the majority of Phnom Penh s administrative districts. Up to 200 household contacts may also be enrolled each year, bringing the overall total to 2,200 individuals enrolled per year. To account for screen failures, our total accrual ceiling over 3 years is 8,100.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 - 65 years of age.
- Residing in Phnom Penh since January 1, 2020.
- Ability to provide consent.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any acute illness requiring a visit to a clinic or hospital on the same day as study enrollment.
- Any underlying, chronic, or current medical condition that, in the opinion of the investigator, would interfere with participation in the study (e.g., inability or great difficulty in drawing blood).
Trial locations and contacts
2 sites in 1 country.
Cambodia2 sites
Cambodian Center for Communicable Disease (CCDC), Ministry of Health (MOH)
Phnom Penh
National Malaria Center (CNM), Ministry of Health (MOH)
Phnom Penh
About this study
Official title: Defining the COVID-19 Immunity Denominator in the Mekong: a Cross-Sectional Seroprevalence Study of SARS-CoV-2 in Healthy Volunteers
Background:
In early 2020, many people thought Cambodia would have a serious COVID-19 outbreak due to the high number of Chinese travelers going to Cambodia. But as of June 14, 2020, only 128 cases of COVID-19 have been identified in the country. Many of these cases have been from people who had traveled in Europe. Researchers want to do antibody tests on blood from a sampling of people in Phnom Penh to learn the infection risks for people in the greater Phnom Penh area.
Read more
Objective:
To estimate the level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the blood of people living in Phnom Penh, Cambodia.
Eligibility:
Healthy males and females age 18-65 living in Phnom Penh since January 2020.
Design:
A mobile unit will travel to schools, shopping areas, parks, and pagodas around Phnom Penh.
Participants will be screened with questions about their age and where they live. They will have blood taken via fingerstick. About 80 uL of blood will be taken. It will be tested for SARS-CoV-2. This visit will take about 30 minutes.
If the test result is positive, participants will be contacted by phone. They will be asked to have a second blood draw. This time, 20 mL of blood will be taken. They can have this visit at their home or in a clinic. This visit will take about 30 minutes.
If a participant has an adverse event, the mobile units and at-home units will have the tools needed to aid the participant. If needed, the participant will be sent to a nearby clinic.
Read the detailed description
This is a cross-sectional study performed annually over 3 years to procure blood samples by fingerstick from healthy individuals living in the Phnom Penh area to evaluate seroprevalence to SARS-CoV-2. A mobile unit will move between various markets, schools, hospitals, clinics, parks, and other public places with local authority permissions. Participants with a positive result on the screening SARS-CoV-2 ELISA will be contacted via telephone (since there is not reliable mail in Cambodia) and invited to undergo an additional blood draw via venipuncture during a home visit by the mobile team within 180 days of the initial sample collection. This visit may also be conducted by CCDC/CNM/MOH study staff at a local clinic. Up to 10 of their adult household contacts will be invited to enroll and screen at this time via fingerstick for SARS-CoV-2 ELISA as part of an enriched sampling scheme to boost the probability of identifying SARSCoV- 2 immune individuals; those with positive results will be invited to undergo follow-up venipuncture as described above. Venipuncture samples will be used to study the immune responses of Cambodians to the novel coronavirus.
- Conditions
- Healthy Volunteers
- Keywords
- Mobile Units, SARS-CoV-2 Immunoglobulin-Positive, Antibody-Based Tests, ELISA, Phnom Penh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Any adult aged 18 to 65 years of age living in Phnom Penh that is sufficiently healthy and willing to undergo fingerstick by the mobile unit for SARS-CoV-2 ELISA assays. | |
| Household contacts | Adult relatives of the healthy volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of SARSCoV-2 immunoglobulin in participant sera by ELISA optical density change.
Using convenience sampling at randomized points across Phnom Penh, ELISAs to the SARS-CoV-2 full-length spike and ribonucleocapsid protein (RNP) antigens will be used as these are the most sensitive and specific to be interpreted in the setting of any background noise introduced by Cambodian sera, and because they are less expensive and amenable to high-throughput processing.
Measured: Enrollment Day 1 (and Study Visit 2 if applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start24 Sep 2021
- Primary completion24 Sep 2021
- Study completion30 Sep 2021
Why it stopped: Study never initiated in Cambodia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jessica E Manning, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594395
- Sponsor's protocol ID
- 10000083
- Other IDs
- 000083-I
- Status last verified
- Oct 2021
- First submitted
- 17 Oct 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
Publications
Lang Z, Reiczigel J. Confidence limits for prevalence of disease adjusted for estimated sensitivity and specificity. Prev Vet Med. 2014 Jan 1;113(1):13-22. doi: 10.1016/j.prevetmed.2013.09.015.
PubMed 24416798
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the COVID-19 Immunity Denominator in the Mekong: a Cross-Sectional Seroprevalence Study of SARS-CoV-2 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04594395
- Acronym / sponsor ID
- 10000083
- Conditions
- Healthy Volunteers
- Keywords
- Mobile Units, SARS-CoV-2 Immunoglobulin-Positive, Antibody-Based Tests, ELISA, Phnom Penh
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never initiated in Cambodia
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 20 Oct 2020 (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.
Background:
In early 2020, many people thought Cambodia would have a serious COVID-19 outbreak due to the high number of Chinese travelers going to Cambodia. But as of June 14, 2020, only 128 cases of COVID-19 have been identified in the country. Many of these cases have been from people who had traveled in Europe. Researchers want to do antibody tests on blood from a sampling of people in Phnom Penh to learn the infection risks for people in the greater Phnom Penh area.
Objective:
To estimate the level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the blood of people living in Phnom Penh, Cambodia.
Eligibility:
Healthy males and females age 18-65 living in Phnom Penh since January 2020.
Design:
A mobile unit will travel to schools, shopping areas, parks, and pagodas around Phnom Penh.
Participants will be screened with questions about their age and where they live. They will have blood taken via fingerstick. About 80 uL of blood will be taken. It will be tested for SARS-CoV-2. This visit will take about 30 minutes.
If the test result is positive, participants will be contacted by phone. They will be asked to have a second blood draw. This time, 20 mL of blood will be taken. They can have this visit at their home or in a clinic. This visit will take about 30 minutes.
If a participant has an adverse event, the mobile units and at-home units will have the tools needed to aid the participant. If needed, the participant will be sent to a nearby clinic.
Detailed description
This is a cross-sectional study performed annually over 3 years to procure blood samples by fingerstick from healthy individuals living in the Phnom Penh area to evaluate seroprevalence to SARS-CoV-2. A mobile unit will move between various markets, schools, hospitals, clinics, parks, and other public places with local authority permissions. Participants with a positive result on the screening SARS-CoV-2 ELISA will be contacted via telephone (since there is not reliable mail in Cambodia) and invited to undergo an additional blood draw via venipuncture during a home visit by the mobile team within 180 days of the initial sample collection. This visit may also be conducted by CCDC/CNM/MOH study staff at a local clinic. Up to 10 of their adult household contacts will be invited to enroll and screen at this time via fingerstick for SARS-CoV-2 ELISA as part of an enriched sampling scheme to boost the probability of identifying SARSCoV- 2 immune individuals; those with positive results will be invited to undergo follow-up venipuncture as described above. Venipuncture samples will be used to study the immune responses of Cambodians to the novel coronavirus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –Any adult aged 18 to 65 years of age living in Phnom Penh that is sufficiently healthy and willing to undergo fingerstick by the mobile unit for SARS-CoV-2 ELISA assays. |
| Household contacts | – | –Adult relatives of the healthy volunteers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Advertising and recruitment in this province will mainly be via word of mouth using health staff and the local village chiefs to communicate to the general public when and where the mobile unit will be sampling. Large signs and banners will be made to hang wherever the mobile unit set up in the designated area. We anticipate having to screen no more than 2,500 individuals per year to enroll our target of 2,000 participants per year over the next 3 years. We have no pre-set male:female ratios or age structures. We do plan to sample many different small clusters from the majority of Phnom Penh s administrative districts. Up to 200 household contacts may also be enrolled each year, bringing the overall total to 2,200 individuals enrolled per year. To account for screen failures, our total accrual ceiling over 3 years is 8,100.
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 - 65 years of age.
- Residing in Phnom Penh since January 1, 2020.
- Ability to provide consent.
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any acute illness requiring a visit to a clinic or hospital on the same day as study enrollment.
- Any underlying, chronic, or current medical condition that, in the opinion of the investigator, would interfere with participation in the study (e.g., inability or great difficulty in drawing blood).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence or absence of SARSCoV-2 immunoglobulin in participant sera by ELISA optical density change.
Time frame: Enrollment Day 1 (and Study Visit 2 if applicable)
Using convenience sampling at randomized points across Phnom Penh, ELISAs to the SARS-CoV-2 full-length spike and ribonucleocapsid protein (RNP) antigens will be used as these are the most sensitive and specific to be interpreted in the setting of any background noise introduced by Cambodian sera, and because they are less expensive and amenable to high-throughput processing.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Background: PubMed 24416798Lang Z, Reiczigel J. Confidence limits for prevalence of disease adjusted for estimated sensitivity and specificity. Prev Vet Med. 2014 Jan 1;113(1):13-22. doi: 10.1016/j.prevetmed.2013.09.015.
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Screening Protocol
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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.
Jessica E Manning, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Cambodia.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cambodia. 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 was withdrawn before enrolling participants, so there are no results.
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?
Presence or absence of SARSCoV-2 immunoglobulin in participant sera by ELISA optical density change. (time frame: Enrollment Day 1 (and Study Visit 2 if applicable)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04594395, which also lists 1 linked publication.
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 4 Oct 2021.