Covid19NCT04824677
Risk Factors and Prognoses in Patients Hospitalized for COVID-19
An observational study of Covid19, run by Sociedad Española de Neumología y Cirugía Torácica at 2 sites in Spain.
Trial summary
Multicenter and observational study. The study will include patients admitted to hospitals in the Lleida health region with confirmed COVID-19. Follow-up will be carried out up to six months after hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Hospital treatment of COVID disease
- How many people
- 971 participants
- Where
- 2 sitesSpain
- Study dates
- 18 May 2020to 31 Dec 2022
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the participating centers of the Lleida health region, with a positive laboratory diagnosis for COVID19.
Who may be able to join
- Laboratory confirmed COVID-19 infection.
- Hospitalization in a center in the Lleida healthcare region.
Who cannot join
- Patients admitted with repeatedly negative COVID-19 test results.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitari Arnau de Vilanova
Lleida, 25198
Hospital Universitari Santa Maria
Lleida, 25198
About this study
Multicenter and observational study. The study will include patients admitted to hospitals in the Lleida health region with confirmed COVID-19. Follow-up will be carried out up to six months after hospital discharge.
Through the analysis of clinical data and biological parameters, it is possible to identify in advance patients who will evolve in an unfavorable prognosis in relation to COVID-19, either because they present criteria of severe disease or because they present thrombotic complications associated with the disease. The final aim is to make anticipated and individualized therapeutic decisions that reduce the morbidity and mortality associated with the disease.
Read the detailed description
The main objective is to develop a predictive model of adverse events in hospitalized COVID-19 patients (death, initiation of mechanical ventilation, ICU admission and thrombotic event). An additional analyses will be performed for each individualized outcome.
Metodology: Prospective case-only study. The variables that will be collected are:
- Previous epidemiological data of the patient.
- Clinical and biological data and treatment upon admission to the hospital.
- Clinical and biological evolutionary data (Increases in the values of certain biological variables in a defined period of time (> 48 h) during admission):
- Baseline epidemiological and clinical variables
- Baseline biological variables
- Complications and clinical evolutionary variables
- Evolutionary biological variables
- Clinical evolutionary data of final outcomes, including death (at 30, 90 days and at 6 months), initiation of mechanical ventilation, ICU admission and thrombotic event.
- For future studies of new biological and epigenetic variables, blood samples will be collected from hospitalized patients under the CIBER coverage.
- Conditions
- Covid19
- Being tested
- Hospital treatment of COVID disease
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital treatment of COVID diseaseOther
Hospital treatment of COVID disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint (death, initiation of mechanical ventilation, ICU admission and thrombotic event)
Development of a predictive model of adverse events (death, initiation of mechanical ventilation, ICU admission and thrombotic event).
Measured: 18 months
Secondary outcomes (4)
Death
Development of a predictive model for mortality risk.
Measured: 18 months
Mechanical ventilation
Development of a predictive model for the need of mechanical ventilation.
Measured: 18 months
ICU admission
Development of a predictive model for admission at the ICU.
Measured: 18 months
Thrombotic event
Development of a predictive model for the risk of thrombotic events.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start18 May 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 971 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Ferran Barbé, MD, Principal investigator, Spanish Respiratory Society (SEPAR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824677
- Sponsor's protocol ID
- COVID-Ponent
- Status last verified
- Nov 2023
- First submitted
- 24 Mar 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Belmonte T, Perez-Pons M, Benitez ID, Molinero M, Garcia-Hidalgo MC, Rodriguez-Munoz C, Gort-Paniello C, Moncusi-Moix A, Made A, Devaux Y, Martelli F, Ortega A, Gonzalez J, Torres G, Barbe F, de Gonzalo-Calvo D. Addressing the unsolved challenges in microRNA-based biomarker development: Suitable endogenous reference microRNAs for SARS-CoV-2 infection severity. Int J Biol Macromol. 2024 Jun;269(Pt 2):131926. doi: 10.1016/j.ijbiomac.2024.131926. Epub 2024 Apr 28.
PubMed 38688344
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Prognoses in Patients Hospitalized for COVID-19
- ClinicalTrials.gov ID
- NCT04824677
- Acronym / sponsor ID
- COVID-Ponent
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 971 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Apr 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.
Multicenter and observational study. The study will include patients admitted to hospitals in the Lleida health region with confirmed COVID-19. Follow-up will be carried out up to six months after hospital discharge.
Through the analysis of clinical data and biological parameters, it is possible to identify in advance patients who will evolve in an unfavorable prognosis in relation to COVID-19, either because they present criteria of severe disease or because they present thrombotic complications associated with the disease. The final aim is to make anticipated and individualized therapeutic decisions that reduce the morbidity and mortality associated with the disease.
Detailed description
The main objective is to develop a predictive model of adverse events in hospitalized COVID-19 patients (death, initiation of mechanical ventilation, ICU admission and thrombotic event). An additional analyses will be performed for each individualized outcome.
Metodology: Prospective case-only study. The variables that will be collected are:
- Previous epidemiological data of the patient.
- Clinical and biological data and treatment upon admission to the hospital.
- Clinical and biological evolutionary data (Increases in the values of certain biological variables in a defined period of time (> 48 h) during admission):
- Baseline epidemiological and clinical variables
- Baseline biological variables
- Complications and clinical evolutionary variables
- Evolutionary biological variables
- Clinical evolutionary data of final outcomes, including death (at 30, 90 days and at 6 months), initiation of mechanical ventilation, ICU admission and thrombotic event.
- For future studies of new biological and epigenetic variables, blood samples will be collected from hospitalized patients under the CIBER coverage.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the participating centers of the Lleida health region, with a positive laboratory diagnosis for COVID19.
Key inclusion criteria (2 listed)
- Laboratory confirmed COVID-19 infection.
- Hospitalization in a center in the Lleida healthcare region.
Key exclusion criteria (1 listed)
- Patients admitted with repeatedly negative COVID-19 test results.
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 |
|---|---|---|
| Hospital treatment of COVID diseaseHospital treatment of COVID disease | Other | – |
Primary outcome
Composite endpoint (death, initiation of mechanical ventilation, ICU admission and thrombotic event)
Time frame: 18 months
Development of a predictive model of adverse events (death, initiation of mechanical ventilation, ICU admission and thrombotic event).
4 secondary outcomes
Death
Time frame: 18 months
Mechanical ventilation
Time frame: 18 months
ICU admission
Time frame: 18 months
Thrombotic event
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 38688344Belmonte T, Perez-Pons M, Benitez ID, Molinero M, Garcia-Hidalgo MC, Rodriguez-Munoz C, Gort-Paniello C, Moncusi-Moix A, Made A, Devaux Y, Martelli F, Ortega A, Gonzalez J, Torres G, Barbe F, de Gonzalo-Calvo D. Addressing the unsolved challenges in microRNA-based biomarker development: Suitable endogenous reference microRNAs for SARS-CoV-2 infection severity. Int J Biol Macromol. 2024 Jun;269(Pt 2):131926. doi: 10.1016/j.ijbiomac.2024.131926. Epub 2024 Apr 28.
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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.
Ferran Barbé, MD principal investigator
Spanish Respiratory Society (SEPAR)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Sociedad Española de Neumología y Cirugía Torácica at 2 sites 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 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: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint (death, initiation of mechanical ventilation, ICU admission and thrombotic event) (time frame: 18 months). 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 NCT04824677, which also lists 1 linked publication.
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 22 Nov 2023.