Professional's Health in Epidemiological Crisis Covid-19

NCT ID: NCT04885478

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-30
• Study Completion Date: 2022-06-30

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.

Conditions

COVID-19; SARS-CoV-2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy health care workers

≥ 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

RT-PCR (SARS-CoV2), negative at baseline or follow up

Anti-SARS-CoV-2 IgG and IgM antibodies (Nucleopcapside), negative positive at baseline or follow up

Immune response monitoring , blood samples

Intervention Type: OTHER

In both cohorts:

-SARS-CoV-2 IgG and IgM antibodies, ( Nucleocapside, Spike) in 8 visits during a year.

Infected HCW:

• Cytokines and T-Cell determination at baseline, 30, 60,180 days, 365 after positive test ( RT-PCR or SARS-CoV-2 antibodies )
• Covid-19 Symptoms, clinical monitoring

Infected health care workers

≥ 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

RT-PCR (SARS-CoV2), positive at baseline or follow up

Anti-SARS-CoV-2 IgG and IgM antibodies (Nucleopcapside), positive at baseline or follow up

Immune response monitoring , blood samples

Intervention Type: OTHER

In both cohorts:

-SARS-CoV-2 IgG and IgM antibodies, ( Nucleocapside, Spike) in 8 visits during a year.

Infected HCW:

• Cytokines and T-Cell determination at baseline, 30, 60,180 days, 365 after positive test ( RT-PCR or SARS-CoV-2 antibodies )
• Covid-19 Symptoms, clinical monitoring

Interventions

Immune response monitoring , blood samples

In both cohorts:

-SARS-CoV-2 IgG and IgM antibodies, ( Nucleocapside, Spike) in 8 visits during a year.

Infected HCW:

• Cytokines and T-Cell determination at baseline, 30, 60,180 days, 365 after positive test ( RT-PCR or SARS-CoV-2 antibodies )
• Covid-19 Symptoms, clinical monitoring

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut Germans Trias i Pujol

OTHER

Sponsor Role: collaborator

IrsiCaixa

OTHER

Sponsor Role: collaborator

Institut Catala de Salut

OTHER_GOV

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Pere Toran, MN

Family Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Concepción Violán Fors, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Locations

Jordi Gol i Gurina Foundation

Mataró, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Concepción Violán Fors, MD, PhD

Role: CONTACT

cviolanf.mn.ics@gencat.cat

+34 629566936

Pere Monteagudo Zaragoza

Role: CONTACT

ugp@idiapjgol.info

+3493 482 42 53

Facility Contacts

Concepción Violán Fors

Role: primary

+34 629566936

Pere Monteagudo Zaragoza

Role: backup

ugp@idiapjgol.info

+34 93 482 42 53

References

Chen ZM, Fu JF, Shu Q, Chen YH, Hua CZ, Li FB, Lin R, Tang LF, Wang TL, Wang W, Wang YS, Xu WZ, Yang ZH, Ye S, Yuan TM, Zhang CM, Zhang YY. Diagnosis and treatment recommendations for pediatric respiratory infection caused by the 2019 novel coronavirus. World J Pediatr. 2020 Jun;16(3):240-246. doi: 10.1007/s12519-020-00345-5. Epub 2020 Feb 5.

Reference Type: BACKGROUND

PMID: 32026148 (View on PubMed)

Liu W, Fontanet A, Zhang PH, Zhan L, Xin ZT, Baril L, Tang F, Lv H, Cao WC. Two-year prospective study of the humoral immune response of patients with severe acute respiratory syndrome. J Infect Dis. 2006 Mar 15;193(6):792-5. doi: 10.1086/500469. Epub 2006 Feb 9.

Reference Type: BACKGROUND

PMID: 16479513 (View on PubMed)

Callow KA, Parry HF, Sergeant M, Tyrrell DA. The time course of the immune response to experimental coronavirus infection of man. Epidemiol Infect. 1990 Oct;105(2):435-46. doi: 10.1017/s0950268800048019.

Reference Type: BACKGROUND

PMID: 2170159 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32880381 (View on PubMed)

Huang AT, Garcia-Carreras B, Hitchings MDT, Yang B, Katzelnick LC, Rattigan SM, Borgert BA, Moreno CA, Solomon BD, Trimmer-Smith L, Etienne V, Rodriguez-Barraquer I, Lessler J, Salje H, Burke DS, Wesolowski A, Cummings DAT. A systematic review of antibody mediated immunity to coronaviruses: kinetics, correlates of protection, and association with severity. Nat Commun. 2020 Sep 17;11(1):4704. doi: 10.1038/s41467-020-18450-4.

Reference Type: RESULT

PMID: 32943637 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36057544 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

4R20-105

Identifier Type: -

Identifier Source: org_study_id