Clinical trial NCT04885478: Professional's Health in Epidemiological Crisis Covid-19
Official title: SARS-CoV-2 Infection Among Healthcare Professionals: Demographic Characteristics and Serological and Immune Responses Related to Progression's Phenotype (ProHEPiC-19)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
SARS-CoV-2
Keywords: COVID-19
Serological test
Kinetics
T cell
Citokines
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Fundació Institut Germans Trias i Pujol
name: IrsiCaixa
name: Institut Catala de Salut
First posted: 2021-05-13
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a multicenter study (public primary care centers set in Mataró, Sabadell and Santa Perpètua and the public third level hospital Hospital Germans Tries i Pujol located in Badalona) with HCW cohorts recruited from Gerència Territorial Metropolitana Nord of the Catalan Institute of Health (ICS), which consists of 7,776 HCW, including physicians, nurses, COVID-19 researchers, medical residents and other essential workers in direct contact with patients during present and future pandemic waves.

Brief summary: Introduction: Coronavirus Disease 2019 (COVID-19) has caused a global pandemic. Epidemiological and clinical inter-individual differences, symptomatology, recovery and humoral response against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) are key factors to better understand and predict the course of the pandemic. As Health Care Workers (HCWs) are caring for infected patients they are more susceptible to infection, which not only is critical for their own health but also because it results in a shortage of HCWs that seriously affects health services. Thus, maintaining the health and welfare of HCWs and enabling their rapid return to work is vital to overcome this crisis. The ProHEpiC-19 cohort presents data on the immune response of HCWs infected with SARS-CoV-2. This dynamic cohort was started in March 2020 and still continues including participants.

Detailed description: Objectives:

Primary: To consolidate a prospective cohort of Health Care Workers (HCWs) to generate epidemiological and clinical high quality data. This information will be relevant to improve health policies and clinical COVID-19 protocols. This cohort will also be used as an ongoing platform to implement SARS-CoV-2 research projects with particular emphasis on incidence rate, reinfection, vaccines, and long term immune response.

Secondary:

1. To determine the kinetics of SARS-CoV-2 antibodies and cellular immune response in early, mid, and long periods of immunization.
2. To assess the relation between clinical variables and initial RT-PCR results with the interindividual differences in the immune response in early, mid, and long periods of immunization.
3. To analyze differentially expressed cytokines as biomarkers of disease progression in early, mid, and long periods of immunization.

Methods and analysis: Longitudinal, dynamic, prospective cohort study with a 12-month follow-up, which is being conducted in 4 primary-care centres and one hospital of Northern Metropolitana Nord of Barcelona (Spain). For now, the study consists of 1350 participants divided into 2 cohorts: 1) Healthy-Exposed HCWs: 675 not infected by SARS-CoV-2 (RT-PCR with a negative result and negative SARS-CoV-2 antibodies at baseline) and 2) Infected HCWs: 675 symptomatic participants (those with new persistent cough, temperature ≥37.5°C, anosmia, or ageusia or other compatible symptoms with COVID-19) or asymptomatic participants diagnosed by positive RT-PCR test and/or SARS-CoV-2 antibodies (IgM, IgG at baseline). Primary outcomes include: humoral and cellular immune response, quantitative antibodies to SARS-Cov-2, SARS-CoV-2 antibody levels related to progression phenotype, clinical spectrum of SARS-Cov-2, symptomatology, demographics and other variables that may be predictive of immune response.

Follow-up: baseline, 15 days, 1, 3, 6, 9 and 12 months. Findings to date: Current literature has shown that the immune response is maintained for a minimum of 2 months. Nevertheless little is known about the association between the immune response and the progression phenotype of COVID-19 .

Future plans: This prospective cohort offers the possibility to study associations between immune response and progression phenotype according to age and gender as well as long-term immune response. In turn, we will be able to examine possible cumulative effects, taking into account several clinical variables. The study is ongoing and we plan to extend it to increase the size of the cohort until 2024.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki.
* To be a health care professional worker infected or exposed to SARS-CoV-2.

Exclusion Criteria:

* \< 18 years old
* Not to accept to take part in the study and/or not to sign the informed consent according to the Declaration of Helsinki.
* Not to be a health care professional worker exposed to SARS-CoV-2

Primary outcomes:
measure: Creation prospective cohort of health care workers
timeFrame: Baseline, to 12 months after the beginning of the study
measure: Cohort description demografics ( age, sex, academic level, housing characteristics, work variables )
timeFrame: Baseline, to 12 months after the beginning of the study
measure: Cohort description clinical spectrum (asymptomatic, mild-moderate Illness, severe-critical)
timeFrame: Baseline, to 12 months after the beginning of the study
Secondary outcomes:
measure: Kinetics of SARS-CoV-2. IgM Nucleocapside
timeFrame: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study
measure: Kinetics of SARS-CoV-2. IgG Nucleocapside
timeFrame: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study
measure: Kinetics of SARS-CoV-2. IgG Spike
timeFrame: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study
measure: Kinetics of SARS-CoV-2. T-Cell
timeFrame: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study
measure: To assess the relation between clinical variables and initial RT-PCR results in the whole sample and by sex.
timeFrame: Baseline, to 12 months after the beginning of the study
measure: To analyse the relation between clinical variables and the interindividual differences in the immune response in early, mid, and long periods of immunization in the whole sample and by sex
timeFrame: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study
measure: Cytokines as biomarkers of disease progression in early, mid, and long periods of immunization.
timeFrame: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Jordi Gol i Gurina Foundation
state: Barcelona
Study officials:
affiliation: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
name: Concepción Violán Fors, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Garcia-Sierra RM, Badia Perich E, Manresa Dominguez JM, Moreno Millan N, Sabate Cintas V, Romero Martinez M, Moreno Gabriel E, Pera G, Seda Gombau G, Montella Jordana N, Violan Fors C, Argerich Gonzalez MJ, Bonet Simo JM, Prat Gil N, Toran Monserrat P. [Descriptive study of the health service workers of a Primary Care Department confined by Covid-19.]. Rev Esp Salud Publica. 2020 Sep 3;94:e202009106. Spanish.
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citation: Violan C, Toran-Monserrat P, Quirant B, Lamonja-Vicente N, Carrasco-Ribelles LA, Chacon C, Manresa-Dominguez JM, Ramos-Roure F, Dacosta-Aguayo R, Palacios-Fernandez C, Roso-Llorach A, Pujol A, Ouchi D, Monteagudo M, Montero-Alia P, Garcia-Sierra R, Armestar F, Dolade M, Prat N, Bonet JM, Clotet B, Blanco I, Boigues-Pons M, Moreno-Millan N, Prado JG, Caceres EMM; ProHEpiC-19 study. Kinetics of humoral immune response over 17 months of COVID-19 pandemic in a large cohort of healthcare workers in Spain: the ProHEpiC-19 study. BMC Infect Dis. 2022 Sep 3;22(1):721. doi: 10.1186/s12879-022-07696-6.