NCT04537338

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2022

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 27, 2020

Last Update Submit

September 1, 2020

Conditions

COVID-19

Keywords

COVID-19Immune Response

Outcome Measures

Primary Outcomes (1)

  • 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

    2-year study

Study Arms (3)

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.

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

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.

Genetic: 1. Characterize the immune response after infection with SARS-CoV-2

Interventions

1. Characterize the immune response after infection with SARS-CoV-2GENETIC

1\. 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

Active / Recovered CasesCommunity control groupHousehold survey

Eligibility Criteria

Age6 Months - 100 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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);

You may not qualify if:

  • 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
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 40102764DERIVED

  • Loria 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.

    PMID: 38070892DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva specimen, serum, plasma

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Rolando Herrerro, Médico

    Agencia Costarricense de Investigaciones Biomedicas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Viviana Loría, Médica

CONTACT

50688653647vloria@acibcr.com

Rebeca Ocampo, Médica

CONTACT

50688163880rocampo@acibcr.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 3, 2020

Study Start

September 14, 2020

Primary Completion

September 14, 2022

Study Completion

September 14, 2022

Last Updated

September 3, 2020

Record last verified: 2020-08