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COVID-19NCT05102708

Study of COVID-19 Prognostic Factors in Hospitalized Patients

An observational study of COVID-19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Severe COVID-19 prognostic factors have been studied worldwide throughout the pandemic, but there is considerable variability. Therefore, the investigators will summarize the identified prognostic factors in the international literature and will conduct a retrospective cohort study to identify the prognostic factors… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Prognostic factors of severe COVID-19
How many people
3,725 participants
Where
1 siteSpain
Study dates
25 Nov 2021to 28 May 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult COVID-19 patients hospitalized at the San Pau Hospital of Barcelona between March 2020 and February 2021.

Who may be able to join

  • Equal or older than 18 years old
  • Hospitalized between March 1st, 2020, and February 28th, 2021.
  • Be diagnosed with COVID-19 disease

Who cannot join

  • Underaged patients
  • > 16h stay in the Emergency Unit

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

Other trials in Spain

About this study

Severe COVID-19 prognostic factors have been studied worldwide throughout the pandemic, but there is considerable variability. Therefore, the investigators will summarize the identified prognostic factors in the international literature and will conduct a retrospective cohort study to identify the prognostic factors of severe COVID-19 in hospitalized patients of the Hospital de la Santa Creu i Sant Pau in Barcelona (Spain) between March 2020 and February 2021, compare them with those mentioned in the international literature and establish those most adequate to our population.

Read the detailed description

Background: Spain is one of the European countries most affected by the SARS-CoV-2 pandemic, with a fatality rate of 2.2%. Faced with the significant number of patients requiring intensive care, the number of beds increased considerably in the span of 11 months to respond to the situation. There is still no drug treatment or specific prognostic factors for COVID-19 that allow its proper management.

Objective: To study the prognostic factors of severity due to COVID-19 in hospitalized patients at Hospital de la Santa Creu i Sant Pau, and their comparison with the prognostic factors identified in the literature review.

Methods: In a first phase, the published studies will be reviewed to identify the existing prognostic factors through various platforms (MEDLINE, EMBASE, Cochrane). A retrospective cohort study will subsequently be carried out to determine the patients' characteristics and to identify the prognostic factors of severity. Patients over 18 years of age, diagnosed with COVID-19 and hospitalized between March 01, 2020 and February 28, 2021 will be included. A descriptive analysis of the cohort will firstly be performed, followed by an analysis of the possible prognostic factors through bivariate tests and multivariate analyzes. The occurrence of admission to intensive care, mortality, and hospital stay > 30 days will be calculated with logistic regression (p <0.05, a = 0.05, 95% confidence interval). Finally, the prognostic factors identified in the literature review will be compared with those determined in the cohort.

Conditions
COVID-19
Being tested
Prognostic factors of severe COVID-19
Keywords
Prognostic Factors, COVID-19, Hospitalization, Critical care, All-cause mortality
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prognostic factors of severe COVID-19Other

    prognostic factors: patients´ epidemiological characteristics (such as age, sex), comorbidities, length of hospitalization, critical care admission, treatments received, laboratory results, vital signs.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    All cause mortality of COVID-19 inpatients

    Measured: one year

  2. Critical care admission

    Critical care admission of COVID-19 inpatients

    Measured: one year

  3. Length of stay

    length of hospital stay equal or longer than 30 days

    Measured: one year

  4. 30-day all cause mortality

    30-day all cause mortality of COVID-19 inpatients

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2021
  2. Study start25 Nov 2021
  3. Primary completion31 Dec 2021
  4. Study completion28 May 2022

Resources

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
Retrospective
Enrolment
3,725 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05102708
Sponsor's protocol ID
IIBSP-COV-2021-75
Status last verified
Aug 2022
First submitted
27 Oct 2021
Last updated
6 Sep 2022
Results posted
No
Individual data sharing
Undecided

Publications

  • Cevik M, Tate M, Lloyd O, Maraolo AE, Schafers J, Ho A. SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis. Lancet Microbe. 2021 Jan;2(1):e13-e22. doi: 10.1016/S2666-5247(20)30172-5. Epub 2020 Nov 19.

    PubMed 33521734

  • Wang Y, Tian H, Zhang L, Zhang M, Guo D, Wu W, Zhang X, Kan GL, Jia L, Huo D, Liu B, Wang X, Sun Y, Wang Q, Yang P, MacIntyre CR. Reduction of secondary transmission of SARS-CoV-2 in households by face mask use, disinfection and social distancing: a cohort study in Beijing, China. BMJ Glob Health. 2020 May;5(5):e002794. doi: 10.1136/bmjgh-2020-002794.

    PubMed 32467353

  • Kronbichler A, Kresse D, Yoon S, Lee KH, Effenberger M, Shin JI. Asymptomatic patients as a source of COVID-19 infections: A systematic review and meta-analysis. Int J Infect Dis. 2020 Sep;98:180-186. doi: 10.1016/j.ijid.2020.06.052. Epub 2020 Jun 17.

    PubMed 32562846

  • Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

    PubMed 32007143

  • Nussbaumer-Streit B, Mayr V, Dobrescu AI, Chapman A, Persad E, Klerings I, Wagner G, Siebert U, Christof C, Zachariah C, Gartlehner G. Quarantine alone or in combination with other public health measures to control COVID-19: a rapid review. Cochrane Database Syst Rev. 2020 Apr 8;4(4):CD013574. doi: 10.1002/14651858.CD013574.

    PubMed 32267544

  • Chu DK, Akl EA, Duda S, Solo K, Yaacoub S, Schunemann HJ; COVID-19 Systematic Urgent Review Group Effort (SURGE) study authors. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. Lancet. 2020 Jun 27;395(10242):1973-1987. doi: 10.1016/S0140-6736(20)31142-9. Epub 2020 Jun 1.

    PubMed 32497510

  • Piechotta V, Chai KL, Valk SJ, Doree C, Monsef I, Wood EM, Lamikanra A, Kimber C, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Jul 10;7(7):CD013600. doi: 10.1002/14651858.CD013600.pub2.

    PubMed 32648959

  • Jain V, Yuan JM. Predictive symptoms and comorbidities for severe COVID-19 and intensive care unit admission: a systematic review and meta-analysis. Int J Public Health. 2020 Jun;65(5):533-546. doi: 10.1007/s00038-020-01390-7. Epub 2020 May 25.

    PubMed 32451563

  • Zhou Y, Yang Q, Chi J, Dong B, Lv W, Shen L, Wang Y. Comorbidities and the risk of severe or fatal outcomes associated with coronavirus disease 2019: A systematic review and meta-analysis. Int J Infect Dis. 2020 Oct;99:47-56. doi: 10.1016/j.ijid.2020.07.029. Epub 2020 Jul 25.

    PubMed 32721533

  • Hatmi ZN. A Systematic Review of Systematic Reviews on the COVID-19 Pandemic. SN Compr Clin Med. 2021;3(2):419-436. doi: 10.1007/s42399-021-00749-y. Epub 2021 Jan 26.

    PubMed 33521564

  • Reddy RK, Charles WN, Sklavounos A, Dutt A, Seed PT, Khajuria A. The effect of smoking on COVID-19 severity: A systematic review and meta-analysis. J Med Virol. 2021 Feb;93(2):1045-1056. doi: 10.1002/jmv.26389. Epub 2020 Aug 13.

    PubMed 32749705

  • Moreno G, Carbonell R, Bodi M, Rodriguez A. Systematic review of the prognostic utility of D-dimer, disseminated intravascular coagulation, and anticoagulant therapy in COVID-19 critically ill patients. Med Intensiva (Engl Ed). 2021 Jan-Feb;45(1):42-55. doi: 10.1016/j.medin.2020.06.006. Epub 2020 Jun 17.

    PubMed 32646669

  • Lazarus G, Audrey J, Wangsaputra VK, Tamara A, Tahapary DL. High admission blood glucose independently predicts poor prognosis in COVID-19 patients: A systematic review and dose-response meta-analysis. Diabetes Res Clin Pract. 2021 Jan;171:108561. doi: 10.1016/j.diabres.2020.108561. Epub 2020 Dec 9.

    PubMed 33310127

  • Martha JW, Wibowo A, Pranata R. Prognostic value of elevated lactate dehydrogenase in patients with COVID-19: a systematic review and meta-analysis. Postgrad Med J. 2022 Jun;98(1160):422-427. doi: 10.1136/postgradmedj-2020-139542. Epub 2021 Jan 15.

    PubMed 33452143

  • Martha JW, Wibowo A, Pranata R. Hypocalcemia is associated with severe COVID-19: A systematic review and meta-analysis. Diabetes Metab Syndr. 2021 Jan-Feb;15(1):337-342. doi: 10.1016/j.dsx.2021.01.003. Epub 2021 Jan 18.

    PubMed 33493853

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 2 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 6 Sep 2022. 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?

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?

All cause mortality (time frame: one year). The study lists 4 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 NCT05102708, which also lists 20 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 6 Sep 2022.

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