COVID-19ProHEpiC-19NCT04885478
Professional's Health in Epidemiological Crisis Covid-19
An observational study of COVID-19 and SARS-CoV-2, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- Immune response monitoring , blood samples
- How many people
- 1,350 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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.
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Jordi Gol i Gurina Foundation
Mataró, Barcelona, 08303
Concepción Violán Fors, +34 629566936
Pere Monteagudo Zaragoza, +34 93 482 42 53, ugp@idiapjgol.info
About this study
Official title: SARS-CoV-2 Infection Among Healthcare Professionals: Demographic Characteristics and Serological and Immune Responses Related to Progression's Phenotype (ProHEPiC-19)
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.
Read the 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:
- To determine the kinetics of SARS-CoV-2 antibodies and cellular immune response in early, mid, and long periods of immunization.
- 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.
- 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
- Being tested
- Immune response monitoring , blood samples
- Keywords
- COVID-19, Serological test, Kinetics, T cell, Citokines
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune response monitoring , blood samplesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Immune response monitoring , blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, to 12 months after the beginning of the study
Secondary outcomes (7)
Kinetics of SARS-CoV-2. IgM Nucleocapside
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
Measured: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study
Kinetics of SARS-CoV-2. IgG Nucleocapside
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
Measured: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study
Kinetics of SARS-CoV-2. IgG Spike
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
Measured: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study
Kinetics of SARS-CoV-2. T-Cell
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).
Measured: 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.
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
Measured: Baseline, to 12 months after the beginning of the study
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
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.
Measured: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study
Cytokines as biomarkers of disease progression in early, mid, and long periods of immunization.
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)
Measured: Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start30 Mar 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol, IrsiCaixa, Institut Catala de Salut
- Responsible party
- Principal investigator, Pere Toran, MN, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- Concepción Violán Fors, MD, PhD, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885478
- Sponsor's protocol ID
- 4R20-105
- Acronym
- ProHEpiC-19
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32026148Liu 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.
PubMed 16479513Callow 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.
PubMed 2170159Garcia-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.
PubMed 32880381Huang 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.
PubMed 32943637Toran-Monserrat P, Lamonja-Vicente N, Costa-Garrido A, Carrasco-Ribelles LA, Quirant B, Boigues M, Molina X, Chacon C, Dacosta-Aguayo R, Armestar F, Martinez Caceres EM, Prado JG, Violan C; ProHEpiC-19 study group. SARS-CoV-2 Infection Risk by Vaccine Doses and Prior Infections Over 24 Months: ProHEpiC-19 Longitudinal Study. JMIR Public Health Surveill. 2024 Nov 22;10:e56926. doi: 10.2196/56926.
PubMed 39648969Violan 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.
PubMed 36057544
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Infection Among Healthcare Professionals: Demographic Characteristics and Serological and Immune Responses Related to Progression's Phenotype (ProHEPiC-19)
- ClinicalTrials.gov ID
- NCT04885478
- Acronym / sponsor ID
- ProHEpiC-19 / 4R20-105
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- COVID-19, Serological test, Kinetics, T cell, Citokines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol, IrsiCaixa, Institut Catala de Salut
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the kinetics of SARS-CoV-2 antibodies and cellular immune response in early, mid, and long periods of immunization.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy health care workers | – | Other: Immune response monitoring , blood samples≥ 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 |
| Infected health care workers | – | Other: Immune response monitoring , blood samples≥ 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- ≥ 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.
Key exclusion criteria (3 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune response monitoring , blood samplesIn 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 | Other | Healthy health care workers, Infected health care workers |
Primary outcome
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.
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.
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.
7 secondary outcomes
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
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
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
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
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 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Background: PubMed 32026148Chen 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.
- Background: PubMed 16479513Liu 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.
- Background: PubMed 2170159Callow 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.
- Results publication: PubMed 32880381Garcia-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.
- Results publication: PubMed 32943637Huang 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.
- Derived from this study: PubMed 39648969Toran-Monserrat P, Lamonja-Vicente N, Costa-Garrido A, Carrasco-Ribelles LA, Quirant B, Boigues M, Molina X, Chacon C, Dacosta-Aguayo R, Armestar F, Martinez Caceres EM, Prado JG, Violan C; ProHEpiC-19 study group. SARS-CoV-2 Infection Risk by Vaccine Doses and Prior Infections Over 24 Months: ProHEpiC-19 Longitudinal Study. JMIR Public Health Surveill. 2024 Nov 22;10:e56926. doi: 10.2196/56926.
- Derived from this study: PubMed 36057544Violan 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.
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COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Concepción Violán Fors, MD, PhD principal investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Concepción Violán Fors, MD, PhD (+34 629566936, cviolanf.mn.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation prospective cohort of health care workers (time frame: Baseline, to 12 months after the beginning of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04885478, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.