Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Professional's Health in Epidemiological Crisis Covid-19 (ProHEpiC-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04885478
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : May 21, 2021
Sponsor:
Collaborators:
Fundació Institut Germans Trias i Pujol
IrsiCaixa
Institut Catala de Salut
Information provided by (Responsible Party):
Pere Toran, MN, Jordi Gol i Gurina Foundation

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.

Condition or disease Intervention/treatment
COVID-19 SARS-CoV-2 Other: Immune response monitoring , blood samples

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SARS-CoV-2 Infection Among Healthcare Professionals: Demographic Characteristics and Serological and Immune Responses Related to Progression's Phenotype (ProHEPiC-19)
Actual Study Start Date : March 30, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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

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

Other: 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




Primary Outcome Measures :
  1. Creation prospective cohort of health care workers [ Time Frame: Baseline, to 12 months after the beginning of the study ]
    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.

  2. Cohort description demografics ( age, sex, academic level, housing characteristics, work variables ) [ Time Frame: Baseline, to 12 months after the beginning of the study ]
    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.

  3. Cohort description clinical spectrum (asymptomatic, mild-moderate Illness, severe-critical) [ Time Frame: Baseline, to 12 months after the beginning of the study ]
    Cohort comparison , an exploratory bivariate analysis will be performed using the tests of Chi Square, ANOVA, Kruskall-Walis, depending on the application conditions assumptions.


Secondary Outcome Measures :
  1. Kinetics of SARS-CoV-2. IgM Nucleocapside [ Time Frame: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study ]
    IgM (nucleocapside) ELISA kits (Inmunodiagnostic Limited ©). Positivity thresholds were provided by the assay manufacturers and were considered positive with an index value greater than 1.1, indeterminate from 0.9 to 1.1 and negative if <0.9 index units

  2. Kinetics of SARS-CoV-2. IgG Nucleocapside [ Time Frame: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study ]
    IgG (nucleocapside) ELISA kits (Inmunodiagnostic Limited ©). Positivity thresholds were provided by the assay manufacturers and were considered positive with an index value greater than 1.1, indeterminate from 0.9 to 1.1 and negative if <0.9 index units

  3. Kinetics of SARS-CoV-2. IgG Spike [ Time Frame: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study ]
    IgG (spike). ELISA kits DECOV1901 (Demeditec Diagnostics GmbH©). Positivity thresholds were provided by the assay manufacturers and were considered positive with an index value greater than 40, indeterminate from 32 to 40 and negative if <32 Ul/ml

  4. Kinetics of SARS-CoV-2. T-Cell [ Time Frame: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study ]
    SARS-CoV-2 specific CD4+ and CD8+ T-cell responses we performed an IFNγ ELISPOT assay. Wells will be considered positive if they contained at least 50 spot-forming cells per 106 PBMCs above the background level (2X mean + 3Xstandard deviation).

  5. To assess the relation between clinical variables and initial RT-PCR results in the whole sample and by sex. [ Time Frame: Baseline, to 12 months after the beginning of the study ]
    To study the differences between clinical spectrums and initial RT-PCR we will use ANOVAs or Kruskal-Wallis tests, after checking normality assumption using a Shapiro-test

  6. 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 [ Time Frame: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study ]
    To study the differences between clinical spectrums and immune response in early period we will use ANOVAs or Kruskal-Wallis tests, after checking normality assumption using a Shapiro-test . Similarly, to look for differences in antibody levels between sex, either a t-test or a Mann-Whitney test will be performed.

  7. Cytokines as biomarkers of disease progression in early, mid, and long periods of immunization. [ Time Frame: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study ]
    Cryopreserved plasma samples will be used in a 45-plex assay of soluble mediators. The plates will be read with a Luminex instrument (Luminex 200, Austin Luminex, USA).Appropriate statistical tests (i.e. t-test or Mann-Whitney to compare between sexes and ANOVA or Kruskal-Wallis to compare between clinical spectrums) will be used after checking for normality (Shapiro-test)


Biospecimen Retention:   Samples With DNA
Blood, Serum , plasma, nasopharyngeal swabs.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04885478


Contacts
Layout table for location contacts
Contact: Concepción Violán Fors, MD, PhD +34 629566936 cviolanf.mn.ics@gencat.cat
Contact: Pere Monteagudo Zaragoza +3493 482 42 53 ugp@idiapjgol.info

Locations
Layout table for location information
Spain
Jordi Gol i Gurina Foundation Recruiting
Mataró, Barcelona, Spain, 08303
Contact: Concepción Violán Fors    +34 629566936      
Contact: Pere Monteagudo Zaragoza    +34 93 482 42 53    ugp@idiapjgol.info   
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Fundació Institut Germans Trias i Pujol
IrsiCaixa
Institut Catala de Salut
Investigators
Layout table for investigator information
Principal Investigator: Concepción Violán Fors, MD, PhD Jordi Gol i Gurina Foundation
  Study Documents (Full-Text)

Documents provided by Pere Toran, MN, Jordi Gol i Gurina Foundation:
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Pere Toran, MN, Family Physician, Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT04885478    
Other Study ID Numbers: 4R20-105
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pere Toran, MN, Jordi Gol i Gurina Foundation:
COVID-19
Serological test
Kinetics
T cell
Citokines
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases