Professional's Health in Epidemiological Crisis Covid-19

NCT04885478 | Unknown DMC

• 1 other identifier: 4R20-105
• Study Type: observational
• Target: 1,350
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; SARS-CoV-2

Keywords

COVID-19; Serological test; Kinetics; T cell; Citokines

Outcome Measures

Primary Outcomes (3)

• Creation prospective cohort of health care workers

  Include 675 exposed HCW participants and 675 infected HCW participants againts SARS-CoV-2, cohorts will be compared at each time point in terms of sociodemographic, epidemiological, clinical, and immunological information available. an exploratory bivariate analysis will be performed using the tests of Chi Square, ANOVA, Kruskall-Walis, depending on the application conditions assumptions.

  Baseline, to 12 months after the beginning of the study

• Cohort description demografics ( age, sex, academic level, housing characteristics, work variables )

  Descriptive analysis of the participants will be performed using the number and percentage for categorical variables, and mean and standard deviation or median and quartiles 1 and 3 for quantitative variables, an exploratory bivariate analysis will be performed using the tests of Chi Square, ANOVA, Kruskall-Walis, depending on the application conditions assumptions.

  Baseline, to 12 months after the beginning of the study

• Cohort description clinical spectrum (asymptomatic, mild-moderate Illness, severe-critical)

  Cohort comparison , an exploratory bivariate analysis will be performed using the tests of Chi Square, ANOVA, Kruskall-Walis, depending on the application conditions assumptions.

  Baseline, to 12 months after the beginning of the study

Secondary Outcomes (7)

• Kinetics of SARS-CoV-2. IgM Nucleocapside

  Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study

• Kinetics of SARS-CoV-2. IgG Nucleocapside

  Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study

• Kinetics of SARS-CoV-2. IgG Spike

  Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study

• Kinetics of SARS-CoV-2. T-Cell

  Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study

• To assess the relation between clinical variables and initial RT-PCR results in the whole sample and by sex.

  Baseline, to 12 months after the beginning of the study

Study Arms (2)

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

Other: Immune response monitoring , blood samples

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

Other: Immune response monitoring , blood samples

Interventions

Immune response monitoring , blood samples 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

Healthy health care workers; Infected health care workers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Fundació Institut Germans Trias i Pujol: collaborator
• IrsiCaixa: collaborator
• Institut Catala de Salut: collaborator

Study Sites (1)

Jordi Gol i Gurina Foundation

Mataró, Barcelona, 08303, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 32026148 BACKGROUND

• 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.

  PMID: 16479513 BACKGROUND

• 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.

  PMID: 2170159 BACKGROUND

• 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.

  PMID: 32880381 RESULT

• 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.

  PMID: 32943637 RESULT

• 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.

  PMID: 36057544 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Serum , plasma, nasopharyngeal swabs.

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Concepción Violán Fors, MD, PhD

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Concepción Violán Fors, MD, PhD

CONTACT

+34 629566936; cviolanf.mn.ics@gencat.cat

Pere Monteagudo Zaragoza

CONTACT

+3493 482 42 53; ugp@idiapjgol.info

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family Physician

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 13, 2021
• Study Start: March 30, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 21, 2021

Record last verified: 2021-05

Locations

ES (1)