Official Title
Evaluation of the Immune Response to SARS-CoV-2 Among Patients With Covid-19 in Costa Rica
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.

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.

Not yet recruiting
COVID-19

Genetic: 1. Characterize the immune response after infection with SARS-CoV-2
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 Cases
Community control group
Household survey

Eligibility Criteria

Inclusion Criteria:

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

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

Exclusion criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 6 Months~Maximum: 100 Years
Contacts

Viviana Loría, Médica
50688653647
vloria@acibcr.com

Rebeca Ocampo, Médica
50688163880
rocampo@acibcr.com

Rolando Herrerro, Médico
Principal Investigator
Agencia Costarricense de Investigaciones Biomedicas

Agencia Costarricense de Investigaciones Biomedicas
Caja Costarricense de Seguro Social
Fundación INCIENSA (FUNIN)
Ministerio de Salud de Costa Rica
Institutos Nacionales de Salud, USA Instituto Alemán del Cáncer
Agencia Costarricense de Investigaciones Biomedicas (ACIB)
NCT Number
Keywords
Covid-19
immune response