COVID-19RESPIRANCT04537338
Evaluation of the Immune Response to SARS-CoV-2 Among Patients With Covid-19 in Costa Rica
An observational study of COVID-19, run by Agencia Costarricense de Investigaciones Biomedicas.
Trial summary
Describe the immune response of patients affected by SARS-CoV-2, including an assessment of the types of antibodies elicited by the infection, specifc antibody titers for the different isotypes, evolution of the antibody response over time, protective efficacy and immune correlates of protection. Read more about this study
- Who is it for?
- Ages 6 months to 100 years
- Conditions the study is for
- COVID-19
- What is being tested?
- 1. Characterize the immune response after infection with SARS-CoV-2
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2020to 14 Sep 2022
- 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 6 months to 100 years
- All sexes
- Child, Adult, Older adult
Study population: This observational study will involve the recruitment of a large series of cases from Costa Rica,including both patients who already recovered from the disease and newly diagnosed cases, regardless of the severity of the clinical presentation.
Who may be able to join
- Recruitment of cases Eligibility criteria Inclusion criteria
- Potential participants will be deemed eligible if they are:
- Diagnosed with Covid-19 disease by a positive PCR test in Costa Rica since March 2020
- Able to communicate with study personnel (or parents for children under 12);
- Able and willing to provide a blood sample (or parents);
- Not planning to move put of the study area in the next 12 months Exclusion criteria
Show all 17Show fewer
- Potential participants will be excluded or deferred from enrollment if:
- They are in critical clinical condition precluding enrollment at the discretion of the treating clinicians (deferral)
- The clinician determining eligibility in agreement with the principal investigator considers that there is a reason that precludes participation;
- The participant or her parent/legal guardian, as applicable, does not have an identification document.
- Enrollment of active cases Most of the cases of Covid-19 are treated at CCSS hospitals or clnics, where the it is a disease of mandatory reporting. Personnel of the Social Security or Ministry of Health will inform the potential participant case about the study and ask if they are willing to be contacted by study personnel to receive further information. The intention is to recruit all cases with the disease registered in Costa Rica.
- Enrollment of recovered cases
- Recovered cases are subjects previously diagnosed with Covid-19 via a positive PCR test who were considered recovered because they had two consecutive negative PCR tests. The first cases was diagnosed in March 2020. They will be contacted and recruited at home based on the registration lists of the CCSS and the Ministry of Health, their eligibility criteria and consent procedures will be similar to those of the active cases, but their specimen collection will be different Community control group selection and enrollment Inclusion criteria
- Potential participants will be deemed eligible if they are:
- Able to communicate with study personnel (or parents for children under 12);
- Able and willing to provide a blood sample (or parents);
- Not planning to move out of the study area in the next 12 months
Who cannot join
- Potential participants will be excluded or deferred from enrollment if:
- They have incapacitating or other conditions impeding participation as determined by the study team
- The participant or her parent/legal guardian, as applicable, does not have an identification document.
Trial locations and contacts
No sites are listed yet.
About this study
Describe the immune response of patients affected by SARS-CoV-2, including an assessment of the types of antibodies elicited by the infection, specifc antibody titers for the different isotypes, evolution of the antibody response over time, protective efficacy and immune correlates of protection.
investigate genetic determinants of Covid-19 and of the imune response to this condition.
Finally, the study will investigate secondary infection rate and its determinants among household contacts of Covid-19 patients.
Read the detailed description
The main objective of the study is to describe the immune response to the SARS-CoV-2 virus among patients with confirmed Covid-19 disease in terms of antibody levels, differences in response related to epidemiologic and clinical characteristics, duration of the antibody response and protective efficacy.
Of particular interest is the demonstration of seroconversion with neutralizing antibodies, their duration during a follow-up of two years and their ability to prevent subsequent infections and disease. If antibodies are demonstrated to protect against subsequent infections and that protection is long-lasting, this can be instrumental for the reincorporation of immune individuals into normal life and economic activities.
Additional secondary objectives include determination of population-prevalence of past infection and assessment of genetic determinants of the immune response and the clinical presentation of the disease. Finally, we will investigate secondary transmission in a sample of household contacts of Covid-19 cases.
This study will provide important information to define the use of specific types of antibodies and their potential utility for diagnosis, ascertainment of previous exposure and acquired immunity. The effort is being conducted by the Caja Costarricense de Seguro Social, the Costa Rican Ministry of Health and the Agencia Costarricense de Investigaciones Biomédicas (ACIB), in collaboration with the US National Cancer Institute, the US National Institute of Allergy and Infectious Diseases and the German Cancer Research Center and will be supervised by the Ethical Committee of the CCSS according to local regulations.
- Conditions
- COVID-19
- Being tested
- 1. Characterize the immune response after infection with SARS-CoV-2
- Keywords
- COVID-19, Immune Response
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Characterize the immune response after infection with SARS-CoV-2Genetic
- Characterize the immune response after infection with SARS-CoV-2 in terms of type of antibodies (IgM, IgG, IgA), seroconversion, maximum antibody levels, , and response to different viral proteins/antigens
| Study group | Role | What they receive |
|---|---|---|
| Active / Recovered Cases | Active Cases:
Diagnosed with Covid-19 disease by a positive PCR test in Costa Rica since March 2020.
Most of the cases of Covid-19 are treated at CCSS hospitals or clnics.
Recovered cases:
Are subjects previously diagnosed with Covid-19 via a positive PCR test who were considered recovered because they had two consecutive negative PCR tests. Receives: Genetic: 1. Characterize the immune response after infection with SARS-CoV-2 | |
| Community control group | The community control group will be frequency-matched on age, sex and area of residence. Two controls per case will be selected as follows Receives: Genetic: 1. Characterize the immune response after infection with SARS-CoV-2 | |
| Household survey | Are a household contact of a person diagnosed with Covid-19 disease by a positive PCR test in Costa Rica since March 2020.
A household will be defined as a group of persons living together who share a kitchen. To be considered eligible for inclusion a contact must have spent at least one night per week in the living area since onset in the index case. Receives: Genetic: 1. Characterize the immune response after infection with SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Seroconversion
Evaluation of patterns of antibody responses over time, correlation between measures ((IgM, IgG, IgA), and determinants of antibody responses for common exposures
Measured: 2-year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start14 Sep 2020 (estimated)
- Primary completion14 Sep 2022 (estimated)
- Study completion14 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agencia Costarricense de Investigaciones Biomedicas
- Sponsor type
- University, hospital or other
- Collaborators
- Caja Costarricense de Seguro Social, Fundación Inciensa, Ministerio de Salud de Costa Rica, Institutos Nacionales de Salud, USA Instituto Alemán del Cáncer, Agencia Costarricense de Investigaciones Biomedicas (ACIB)
- Responsible party
- Sponsor
- Investigators
- Rolando Herrerro, Médico, Principal investigator, Agencia Costarricense de Investigaciones Biomedicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537338
- Sponsor's protocol ID
- R020-SABI-00261
- Acronym
- RESPIRA
- Status last verified
- Aug 2020
- First submitted
- 27 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Herrero R, Fantin R, Loria V, Aparicio A, Prevots DR, Zuniga M, Wong R, Morera M, Butt J, Binder M, Abdelnour A, Calderon A, Castro R, Cortes B, Ocampo R, Vanegas JC, Gail MH, Pfeiffer RM, Flock J, Remans K, Eberhardt L, Rastgou S, Magalhaes V, Porras C, Hildesheim A, Waterboer T; RESPIRA study group. Time course and determinants of the antibody response to SARS-CoV-2 in Costa Rica: the RESPIRA study. BMC Infect Dis. 2025 Mar 18;25(1):376. doi: 10.1186/s12879-025-10742-8.
PubMed 40102764Loria V, Aparicio A, Hildesheim A, Cortes B, Barrientos G, Retana D, Sun K, Ocampo R, Prevots DR, Zuniga M, Waterboer T, Wong-McClure R, Morera M, Butt J, Binder M, Abdelnour A, Calderon A, Gail MH, Pfeiffer RM, Solis CB, Fantin R, Vanegas JC, Mercado R, Avila C, Porras C, Herrero R. Cohort profile: evaluation of immune response and household transmission of SARS-CoV-2 in Costa Rica: the RESPIRA study. BMJ Open. 2023 Dec 9;13(12):e071284. doi: 10.1136/bmjopen-2022-071284.
PubMed 38070892
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immune Response to SARS-CoV-2 Among Patients With Covid-19 in Costa Rica
- ClinicalTrials.gov ID
- NCT04537338
- Acronym / sponsor ID
- RESPIRA / R020-SABI-00261
- Conditions
- COVID-19
- Keywords
- COVID-19, Immune Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Agencia Costarricense de Investigaciones BiomedicasUniversity, hospital or other
- Collaborators
- Caja Costarricense de Seguro Social, Fundación Inciensa, Ministerio de Salud de Costa Rica, Institutos Nacionales de Salud, USA Instituto Alemán del Cáncer, Agencia Costarricense de Investigaciones Biomedicas (ACIB)
- Study start
- 14 Sep 2020 (estimated)
- Primary completion
- 14 Sep 2022 (estimated)
- Study completion
- 14 Sep 2022 (estimated)
- First posted
- 3 Sep 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.
Describe the immune response of patients affected by SARS-CoV-2, including an assessment of the types of antibodies elicited by the infection, specifc antibody titers for the different isotypes, evolution of the antibody response over time, protective efficacy and immune correlates of protection.
investigate genetic determinants of Covid-19 and of the imune response to this condition.
Finally, the study will investigate secondary infection rate and its determinants among household contacts of Covid-19 patients.
Detailed description
The main objective of the study is to describe the immune response to the SARS-CoV-2 virus among patients with confirmed Covid-19 disease in terms of antibody levels, differences in response related to epidemiologic and clinical characteristics, duration of the antibody response and protective efficacy.
Of particular interest is the demonstration of seroconversion with neutralizing antibodies, their duration during a follow-up of two years and their ability to prevent subsequent infections and disease. If antibodies are demonstrated to protect against subsequent infections and that protection is long-lasting, this can be instrumental for the reincorporation of immune individuals into normal life and economic activities.
Additional secondary objectives include determination of population-prevalence of past infection and assessment of genetic determinants of the immune response and the clinical presentation of the disease. Finally, we will investigate secondary transmission in a sample of household contacts of Covid-19 cases.
This study will provide important information to define the use of specific types of antibodies and their potential utility for diagnosis, ascertainment of previous exposure and acquired immunity. The effort is being conducted by the Caja Costarricense de Seguro Social, the Costa Rican Ministry of Health and the Agencia Costarricense de Investigaciones Biomédicas (ACIB), in collaboration with the US National Cancer Institute, the US National Institute of Allergy and Infectious Diseases and the German Cancer Research Center and will be supervised by the Ethical Committee of the CCSS according to local regulations.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active / Recovered Cases | – | Genetic: 1. Characterize the immune response after infection with SARS-CoV-2Active Cases: Diagnosed with Covid-19 disease by a positive PCR test in Costa Rica since March 2020. Most of the cases of Covid-19 are treated at CCSS hospitals or clnics. Recovered cases: Are subjects previously diagnosed with Covid-19 via a positive PCR test who were considered recovered because they had two consecutive negative PCR tests. |
| Community control group | – | Genetic: 1. Characterize the immune response after infection with SARS-CoV-2The community control group will be frequency-matched on age, sex and area of residence. Two controls per case will be selected as follows |
| Household survey | – | Genetic: 1. Characterize the immune response after infection with SARS-CoV-2Are a household contact of a person diagnosed with Covid-19 disease by a positive PCR test in Costa Rica since March 2020. A household will be defined as a group of persons living together who share a kitchen. To be considered eligible for inclusion a contact must have spent at least one night per week in the living area since onset in the index case. |
Who may qualify
- Ages
- 6 months to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This observational study will involve the recruitment of a large series of cases from Costa Rica,including both patients who already recovered from the disease and newly diagnosed cases, regardless of the severity of the clinical presentation.
Key inclusion criteria (17 listed)
- Recruitment of cases Eligibility criteria Inclusion criteria
- Diagnosed with Covid-19 disease by a positive PCR test in Costa Rica since March 2020
- Able to communicate with study personnel (or parents for children under 12);
- Able and willing to provide a blood sample (or parents);
- Not planning to move put of the study area in the next 12 months Exclusion criteria
Key exclusion criteria (3 listed)
- They have incapacitating or other conditions impeding participation as determined by the study team
- The participant or her parent/legal guardian, as applicable, does not have an identification document.
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 |
|---|---|---|
| 1. Characterize the immune response after infection with SARS-CoV-21. Characterize the immune response after infection with SARS-CoV-2 in terms of type of antibodies (IgM, IgG, IgA), seroconversion, maximum antibody levels, , and response to different viral proteins/antigens | Genetic | Active / Recovered Cases, Community control group, Household survey |
Primary outcome
COVID-19 Seroconversion
Time frame: 2-year study
Evaluation of patterns of antibody responses over time, correlation between measures ((IgM, IgG, IgA), and determinants of antibody responses for common exposures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 40102764Herrero R, Fantin R, Loria V, Aparicio A, Prevots DR, Zuniga M, Wong R, Morera M, Butt J, Binder M, Abdelnour A, Calderon A, Castro R, Cortes B, Ocampo R, Vanegas JC, Gail MH, Pfeiffer RM, Flock J, Remans K, Eberhardt L, Rastgou S, Magalhaes V, Porras C, Hildesheim A, Waterboer T; RESPIRA study group. Time course and determinants of the antibody response to SARS-CoV-2 in Costa Rica: the RESPIRA study. BMC Infect Dis. 2025 Mar 18;25(1):376. doi: 10.1186/s12879-025-10742-8.
- Derived from this study: PubMed 38070892Loria V, Aparicio A, Hildesheim A, Cortes B, Barrientos G, Retana D, Sun K, Ocampo R, Prevots DR, Zuniga M, Waterboer T, Wong-McClure R, Morera M, Butt J, Binder M, Abdelnour A, Calderon A, Gail MH, Pfeiffer RM, Solis CB, Fantin R, Vanegas JC, Mercado R, Avila C, Porras C, Herrero R. Cohort profile: evaluation of immune response and household transmission of SARS-CoV-2 in Costa Rica: the RESPIRA study. BMJ Open. 2023 Dec 9;13(12):e071284. doi: 10.1136/bmjopen-2022-071284.
- Individual participant dataSharing planned: Undecided
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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.
Rolando Herrerro, Médico principal investigator
Agencia Costarricense de Investigaciones Biomedicas
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Agencia Costarricense de Investigaciones Biomedicas.
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 17 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: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Viviana Loría, Médica (50688653647, vloria@acibcr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Seroconversion (time frame: 2-year study). 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 NCT04537338, which also lists 2 linked publications.
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 3 Sep 2020.