Covid19COVID-ScopeNCT05046769
COVID-19: A Scope Research on Epidemiology and Clinical Course
An observational study of Covid19 and SARS CoV 2 Infection, run by Instituto de Saude Publica da Universidade do Porto at 1 site in Portugal.
Trial summary
Severe Acute Respiratory Syndrome (SARS) Coronavirus (CoV) 2 infection and the associated coronavirus disease 2019 (COVID-19) are the most recent international health threat challenging our ability to protect populations, to avoid severe outcomes and to understand both the population dynamics of this new condition and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, SARS CoV 2 Infection, Sequelae of; Infection
- How many people
- 5,000 participants
- Where
- 1 sitePortugal
- Study dates
- 28 Apr 2020to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients with SARS-CoV-2 infection diagnosed at Centro Hospitalar Universitário São João, a level III hospital center, from March 1, 2020. A sample of individuals who underwent the test for diagnosis of infection by SARS-CoV-2 with negative result.
Who may be able to join
- Individuals diagnosed with SARS-2-CoV-2 infection treated at CHUSJ and cohabitants able to give informed consent;
- individuals who underwent the test for diagnosis of infection by SARS-CoV-2 at CHUSJ with negative result able to give informed consent.
Who cannot join
- Inability to obtain informed consent;
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar De São João
Porto, 4200-319
Margarida Tavares, +351225512389, margarida.tavares@chsj.min-saude.pt
About this study
Severe Acute Respiratory Syndrome (SARS) Coronavirus (CoV) 2 infection and the associated coronavirus disease 2019 (COVID-19) are the most recent international health threat challenging our ability to protect populations, to avoid severe outcomes and to understand both the population dynamics of this new condition and the breath of individual responses. Gathering information on the clinical course of the disease and the risk of transmission is essential to design effective therapeutic solutions and preventive measures. The aim of the study proposed, to be carried out at University Hospital Center of "São João" (CHUSJ), is to recruit and follow-up a cohort of patients diagnosed with SARS-CoV-2 infection, to evaluate the clinical course of SARS-CoV-2 infection and COVID-19 cases, to identify prognostic factors and to measure the risk of reinfection. Additionally, researchers intend to characterize the patients and household contacts to describe the dynamics of infection, to calculate household infection attack rate, and to perform the genetic sequencing of SARS-CoV-2 to understand determinants of disease course (namely long-term effects) and risk of household transmission. A sample of participants, identified during the process of evaluation of symptomatic individuals, at the same institution, and negative for SARS-CoV-2 will be selected as negative controls.
Participants will be consecutively recruited and the study is expected to enroll patients as long as the pandemic remains. Information will be gathered based on clinical individual charts, hospital data-bases (example: for administrative data) and individual computer assisted interviews to be performed at pre-defined intervals (3, 12 and 24 months) or according to clinical needs.
The project was approved by the local Ethical Committee and the Data Protection relevant authorities.
- Conditions
- Covid19, SARS CoV 2 Infection, Sequelae of; Infection
- Keywords
- Covid19, Cohort Studies, Long COVID, Secondary Attack Rate, Serology, Epidemiology
- Medical subject headings
- COVID-19, Infections, Post-Acute COVID-19 Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical, biological, psychosocial characteristics
Describe the clinical, biological and psychosocial characteristics SARS-CoV-2 infected inpatients or outpatients identified in our hospital center
Measured: 24 months
Secondary outcomes (4)
Household contacts infection attack rate
Characterize the dynamics of infection
Measured: 3 months
Genome sequence of SARS-CoV-2
Identify variants of SARS-CoV-2
Measured: 24 months
Reinfection rate
Number and characteristics of reinfections
Measured: 24 months
Prognostic factors of course of disease
Identify clinical, biological and social associated with course of disease
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start28 Apr 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Saude Publica da Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto
- Responsible party
- Principal investigator, Margarida Fernandes Tavares, Instituto de Saude Publica da Universidade do Porto
- Investigators
- Margarida Tavares, MD, MPH, Principal investigator, Centro Hospitalar Universitário São João & ISPUP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046769
- Sponsor's protocol ID
- 102-20
- Acronym
- COVID-Scope
- Status last verified
- Sep 2021
- First submitted
- 5 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: A Scope Research on Epidemiology and Clinical Course
- ClinicalTrials.gov ID
- NCT05046769
- Acronym / sponsor ID
- COVID-Scope / 102-20
- Conditions
- Covid19, SARS CoV 2 Infection, Sequelae of; Infection
- Keywords
- Covid19, Cohort Studies, Long COVID, Secondary Attack Rate, Serology, Epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Instituto de Saude Publica da Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Sep 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.
Severe Acute Respiratory Syndrome (SARS) Coronavirus (CoV) 2 infection and the associated coronavirus disease 2019 (COVID-19) are the most recent international health threat challenging our ability to protect populations, to avoid severe outcomes and to understand both the population dynamics of this new condition and the breath of individual responses. Gathering information on the clinical course of the disease and the risk of transmission is essential to design effective therapeutic solutions and preventive measures. The aim of the study proposed, to be carried out at University Hospital Center of "São João" (CHUSJ), is to recruit and follow-up a cohort of patients diagnosed with SARS-CoV-2 infection, to evaluate the clinical course of SARS-CoV-2 infection and COVID-19 cases, to identify prognostic factors and to measure the risk of reinfection. Additionally, researchers intend to characterize the patients and household contacts to describe the dynamics of infection, to calculate household infection attack rate, and to perform the genetic sequencing of SARS-CoV-2 to understand determinants of disease course (namely long-term effects) and risk of household transmission. A sample of participants, identified during the process of evaluation of symptomatic individuals, at the same institution, and negative for SARS-CoV-2 will be selected as negative controls.
Participants will be consecutively recruited and the study is expected to enroll patients as long as the pandemic remains. Information will be gathered based on clinical individual charts, hospital data-bases (example: for administrative data) and individual computer assisted interviews to be performed at pre-defined intervals (3, 12 and 24 months) or according to clinical needs.
The project was approved by the local Ethical Committee and the Data Protection relevant authorities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with SARS-CoV-2 infection diagnosed at Centro Hospitalar Universitário São João, a level III hospital center, from March 1, 2020. A sample of individuals who underwent the test for diagnosis of infection by SARS-CoV-2 with negative result.
Key inclusion criteria (2 listed)
- Individuals diagnosed with SARS-2-CoV-2 infection treated at CHUSJ and cohabitants able to give informed consent;
- individuals who underwent the test for diagnosis of infection by SARS-CoV-2 at CHUSJ with negative result able to give informed consent.
Key exclusion criteria (1 listed)
- Inability to obtain informed consent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical, biological, psychosocial characteristics
Time frame: 24 months
Describe the clinical, biological and psychosocial characteristics SARS-CoV-2 infected inpatients or outpatients identified in our hospital center
4 secondary outcomes
Household contacts infection attack rate
Time frame: 3 months
Genome sequence of SARS-CoV-2
Time frame: 24 months
Reinfection rate
Time frame: 24 months
Prognostic factors of course of disease
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
Margarida Tavares, MD, MPH principal investigator
Centro Hospitalar Universitário São João & ISPUP
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 Covid19 and SARS CoV 2 Infection, run by Instituto de Saude Publica da Universidade do Porto at 1 site in Portugal.
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 2 inclusion and 1 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 16 Sep 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 Portugal. 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 Margarida Tavares, MD, MPH (+351222061820, mftavares@ispup.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical, biological, psychosocial characteristics (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2021.