SARS-CoV2 InfectionGETCOV-2NCT04948242
Characteristics of Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection (COVID-19)
An observational study of SARS-CoV2 Infection, run by Hospital Universitari Joan XXIII de Tarragona. at 1 site in Spain.
Trial summary
A multicenter observational, prospective cohort study that consisted of a large-scale data source of hospital ICU admissions and patient-level clinical data in Spain. The main objective is to develop a national database belonging to SEMICYUC (Spanish Society of Critical Care) to describe epidemiological and clinical… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- SARS-CoV2 Infection
- How many people
- 5,000 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2019to 31 Dec 2023
- How long will I take part?
- 5 Years
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill patients with community-acquired pneumonia due to SARS-CoV-2 infection
Who may be able to join
- Severe community-acquired pneumonia due SARS CoV-2 infection and acute respiratory failure with microbiological confirmation (RT-PCR) according international guidelines
- Age >= 16 years without upper limit
Who cannot join
- Age < 16 years
- Patients with SARS-CoV-2 infection without acute respiratory failure
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Tarragona Joan XXIII
Tarragona, 43007
Alejandro Rodríguez Oviedo, MD,PhD,MsC, +34977295818, ahr1161@yahoo.es
Sandra Trefler Crespo, BsC,PhD, +34977295818, sitrefler@yahoo.es
About this study
Official title: Epidemiologic, Clinical Characteristics and Risk Factors of Critical Ill Patients Admitted to the ICU for Severe Acute Respiratory Syndrome Coronavirus 2 Infection (COVID-19)
A multicenter observational, prospective cohort study that consisted of a large-scale data source of hospital ICU admissions and patient-level clinical data in Spain.
The main objective is to develop a national database belonging to SEMICYUC (Spanish Society of Critical Care) to describe epidemiological and clinical characteristics and risk factors related to ICU mortality in critically ill patients admitted to ICU due to severe COVID-19 in Spain.
Read the detailed description
Design: A multicenter observational, prospective cohort study
Setting: Intensive Care Units
Subjects: Adult Critical patients admitted to ICU with severe community-acquired pneumonia due to confirmed SARS CoV-2 infection (COVID-19).
Data Collection and Validation Data was obtained from a voluntary registry created by Spanish Society of Intensive Care Medicine-SEMICYUC. All consecutive cases admitted to the ICU were collected.
There were no patients excluded from the analysis that was enrolled to participating ICU and met criteria.
Data were collected using a paper CRF (case Report Form). CRF collect and record all protocol-required information, which is transcribed from patient source documents, such as hospital records and laboratory reports during the patient's participation in the study. Before being sent to the National Study Coordinator (AR) this data was de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number. We implemented a double data entry model for potential errors in real-time. Data was entered twice by two different Data Entry personnel based on the same set of data collected in the paper CRFs. All data were reviewed, and values that appeared incongruent or out of range were manually validated by confirming the accuracy of the data with the Study Coordinator (AR). The database was validated and cleaned before the statistical analysis and the study database was locked to prevent any further changes, and to ensure data consistency and integrity for the statistical reporting and analysis.
Sample size calculation:
No statistical sample size calculation was performed a priori, and sample size was equal to the number of patients admitted to the participant's ICUs with confirmed COVID-19 during the study period.
- Conditions
- SARS-CoV2 Infection
- Keywords
- COVID-19, Severe SARS-CoV-2 infection, Critically ill patients, ADRS, Viral pneumonia
- Medical subject headings
- COVID-19, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Consecutive critically ill patients admitted to ICU with severe SARS-CoV-2 infection | Consecutive adult patients (> 16 years) with laboratory confirmed SARS-CoV-2 infection, detected by RT-PCR positive test of nasopharyngeal, oropharyngeal , swab or invasive respiratory samples according to the WHO recommendations. The follow-up of patients was to ICU discharge or death whichever occurred first. No interventions will be made. Only anonymized demographic data, clinical data, laboratory data and ventilatory support data will be collected. There is no standardized pharmacological treatment protocol. Only basic data are collected about the different treatments administered by the attending physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiologic and Clinical Characteristics and risk factors for ICU mortality in critically ill patients with COVID-19 in Spain
To determine demographics and clinical factors associated with ICU mortality at days-28 and ICU discharge
Measured: Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge
Secondary outcomes (2)
Support respiratory type and prognosis
Association between respiratory support used at ICU admission and ICU mortality
Measured: Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge
Comorbidities and prognosis
Association between different comorbidities (diabetes, obesity, hypertension, etc) and ICU mortality
Measured: Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start12 Dec 2019
- Primary completion17 Apr 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV2 InfectionStudies 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)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Joan XXIII de Tarragona.
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Medicina Intensiva,critica y unidades coronarias
- Responsible party
- Principal investigator, Alejandro Rodriguez Oviedo , MD, Hospital Universitari Joan XXIII de Tarragona.
- Investigators
- Alejandro Rodriguez Oviedo, MD,PhD,MsC, Study director, Hospital Universitari de Tarragona Joan XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948242
- Sponsor's protocol ID
- COVID-19/SEMICYUC
- Acronym
- GETCOV-2
- Status last verified
- Apr 2023
- First submitted
- 29 Jun 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berenguer J, Ryan P, Rodriguez-Bano J, Jarrin I, Carratala J, Pachon J, Yllescas M, Arriba JR; COVID-19@Spain Study Group; Fundacion SEIMC-GESIDA; Hospital General Universitario Gregorio Maranon; Hospital Universitario La Paz; Hospital Infanta Leonor; Complejo Hospitalario Virgen de la Salud; Hospital Universitario Rafael Mendez; Hospital Universitario de Cruces; Hospital de Melilla; Hospital San Eloy de Barakaldo; Hospital Universitario Central de Asturias; Hospital General Universitario de Alicante; Hospital Virgen de la Victoria; Hospital Universitario Puerto Real; EOXI Pontevedra e Salnes; Hospital de Figueres; Hospital Sant Jaume de Calella; Hospital del Mar; Hospital Virgen de la Arrixaca; Hospital de Can Misses; Hospital de Sagunto; Hospital Clinico San Cecilio; Hospital Universitario Principe de Asturias; Parc Sanitari Sant Joan de Deu; Hospital Nuestra Senora de Gracia; HC Marbella Internacional Hospital; Hospital La Princesa; Hospital Josep Trueta; Hospital Dos de Maig; Hospital Arnau de Vilanova-Lliria; Hospital General Universitario de Elche; Hospital Clinico Universitario de Valencia; Complejo Asistencial de Avila; Hospital Comarcal de Alcaniz; Hospital Universitario Marques de Valdecilla; Hospital Quiron-Salud de Torrevieja; Hospital Universitario Miguel Servet; SCIAS, Hospital de Barcelona; Fundacion Hospital Universitario Alcorcon; Hospital Alvaro Cunqueiro; Complejo Asistencial Universitario de Salamanca; Hospital Universitario Severo Ochoa; Hospital CIMA-Sanitas; Hospital HLA Inmaculada; Hospital Universitario Rio Hortega; Hospital de Guadalajara; Hospital Universitario Infanta Sofia; Hospital Comarcal de Blanes; Hospital Universitari de Tarragona Joan XXIII; Hospital Universitario Basurto; Hospital Universitario de Canarias; Hospital Universitario de Gran Canaria Dr Negrin; Hospital Son Espases; Hospital Universitario de Mostoles; Complejo Hospitalario Universitario A Coruna; Hospital Costa del Sol; Hospital Clinico Universitario Lozano Blesa; Hospital Mutua de Terrassa; Hospital de la Plana; Hospital Virgen de la Concha-Complejo Asistencial de Zamora; Complejo Hospitalario Universitario Insular Materno-Infantil; Hospital de la Marina Baixa; Hospital Universitario Virgen Macarena; Hospital Universitari de Bellvitge; Hospital Universitario y Politecnico la Fe; Hospital Universitario del Vinalopo; Hospital de Sabadell (Parc Tauli); Hospital Clinic de Barcelona; Hospital Universitario de la Ribera; Fundacion Jimenez Diaz; Hospital Clinico Universitario de Valladolid; Hospital Clinico San Carlos; Hospital Santa Creu i Sant Pau; Clinica Universitaria de Navarra-Campus Madrid; Hospital Son Llatzer; Hospital General de la Defensa Gomez Ulla; Hospital Universitario de Alava; Hospital Santos Reyes; Hospital Dr Jose Molina Orosa; Hospital Vall d'Hebron; Hospital Universitario Rey Juan Carlos; Complejo Hospitalario Universitario Santa Lucia; Hospital Santa Barbara; Complejo Hospitalario Universitario de Ferrol; Hospital de l'Esperit Sant; Hospital Universitario los Arcos del Mar Menor; Hospital HLA Universitario Moncloa; Hospital Virgen del Puerto; Hospital Marina Salud de Denia; Hospital Universitario de Jerez; Hospital Reina Sofia de Tudela; Hospital Clinico Universitario de Santiago de Compostela; Hospital Universitario del Henares; Hospital Universitario Lucus Augusti; Hospital de Donostia; Hospital de Urduliz Alfredo Espinosa; Hospital de Mendaro; Hospital Juan Ramon Jimenez; Hospital de Tortosa Virgen de la Cinta; Hospital Riotinto; Hospital Vega Baja; Hospital Puerta de Hierro; Hospital Universitario de Getafe; Hospital General de la Palma; Hospital El Bierzo; Fundacion Hospital de Calahorra; Hospital Alto Deba; Hospital Universitario San Juan de Alicante; Hospital de Guadarrama; Hospital Universitario de Jaen; Hospital de Mataro; Hospital de Palamos; Hospital Universitario de Valme; Clinica Universitaria de Navarra-Campus Navarra; Hospital Clinica Benidorm; Hospital Doce de Octubre; Hospital Universitario Virgen del Rocio; Hospital Universitario Ramon y Cajal; Hospital Universitario San Pedro; Hospital Quiron A Coruna; HM Sanchinarro; Hospital Francesc de Borja; Complejo Hospitalario Universitario Nuestra Senora de La Candelaria; Hospital Universitario HM Monteprincipe; Hospital Universitario HM Puerta del Sur; Hospital Universitario HM Torrelodones; Hospital Universitario HM Madrid; Hospital Don Benito-Villanueva de la Serena; Hospital de Viladecans; Centro Nacional de Epidemiologia. Characteristics and predictors of death among 4035 consecutively hospitalized patients with COVID-19 in Spain. Clin Microbiol Infect. 2020 Nov;26(11):1525-1536. doi: 10.1016/j.cmi.2020.07.024. Epub 2020 Aug 4.
PubMed 32758659Berenguer J, Borobia AM, Ryan P, Rodriguez-Bano J, Bellon JM, Jarrin I, Carratala J, Pachon J, Carcas AJ, Yllescas M, Arribas JR; COVID-19@Spain and COVID@HULP Study Groups. Development and validation of a prediction model for 30-day mortality in hospitalised patients with COVID-19: the COVID-19 SEIMC score. Thorax. 2021 Sep;76(9):920-929. doi: 10.1136/thoraxjnl-2020-216001. Epub 2021 Feb 25.
PubMed 33632764Rodriguez A, Ruiz-Botella M, Martin-Loeches I, Jimenez Herrera M, Sole-Violan J, Gomez J, Bodi M, Trefler S, Papiol E, Diaz E, Suberviola B, Vallverdu M, Mayor-Vazquez E, Albaya Moreno A, Canabal Berlanga A, Sanchez M, Del Valle Ortiz M, Ballesteros JC, Martin Iglesias L, Marin-Corral J, Lopez Ramos E, Hidalgo Valverde V, Vidaur Tello LV, Sancho Chinesta S, Gonzales de Molina FJ, Herrero Garcia S, Sena Perez CC, Pozo Laderas JC, Rodriguez Garcia R, Estella A, Ferrer R; COVID-19 SEMICYUC Working Group. Deploying unsupervised clustering analysis to derive clinical phenotypes and risk factors associated with mortality risk in 2022 critically ill patients with COVID-19 in Spain. Crit Care. 2021 Feb 15;25(1):63. doi: 10.1186/s13054-021-03487-8.
PubMed 33588914Manrique S, Claverias L, Magret M, Masclans JR, Bodi M, Trefler S, Canadell L, Diaz E, Sole-Violan J, Bisbal-Andres E, Natera RG, Moreno AA, Vallverdu M, Ballesteros JC, Socias L, Vidal FG, Sancho S, Martin-Loeches I, Rodriguez A. Timing of intubation and ICU mortality in COVID-19 patients: a retrospective analysis of 4198 critically ill patients during the first and second waves. BMC Anesthesiol. 2023 Apr 27;23(1):140. doi: 10.1186/s12871-023-02081-5.
PubMed 37106321
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic, Clinical Characteristics and Risk Factors of Critical Ill Patients Admitted to the ICU for Severe Acute Respiratory Syndrome Coronavirus 2 Infection (COVID-19)
- ClinicalTrials.gov ID
- NCT04948242
- Acronym / sponsor ID
- GETCOV-2 / COVID-19/SEMICYUC
- Conditions
- SARS-CoV2 Infection
- Keywords
- COVID-19, Severe SARS-CoV-2 infection, Critically ill patients, ADRS, Viral pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Hospital Universitari Joan XXIII de Tarragona.University, hospital or other
- Collaborators
- Sociedad Española de Medicina Intensiva,critica y unidades coronarias
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Jul 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.
A multicenter observational, prospective cohort study that consisted of a large-scale data source of hospital ICU admissions and patient-level clinical data in Spain.
The main objective is to develop a national database belonging to SEMICYUC (Spanish Society of Critical Care) to describe epidemiological and clinical characteristics and risk factors related to ICU mortality in critically ill patients admitted to ICU due to severe COVID-19 in Spain.
Detailed description
Design: A multicenter observational, prospective cohort study
Setting: Intensive Care Units
Subjects: Adult Critical patients admitted to ICU with severe community-acquired pneumonia due to confirmed SARS CoV-2 infection (COVID-19).
Data Collection and Validation Data was obtained from a voluntary registry created by Spanish Society of Intensive Care Medicine-SEMICYUC. All consecutive cases admitted to the ICU were collected.
There were no patients excluded from the analysis that was enrolled to participating ICU and met criteria.
Data were collected using a paper CRF (case Report Form). CRF collect and record all protocol-required information, which is transcribed from patient source documents, such as hospital records and laboratory reports during the patient's participation in the study. Before being sent to the National Study Coordinator (AR) this data was de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number. We implemented a double data entry model for potential errors in real-time. Data was entered twice by two different Data Entry personnel based on the same set of data collected in the paper CRFs. All data were reviewed, and values that appeared incongruent or out of range were manually validated by confirming the accuracy of the data with the Study Coordinator (AR). The database was validated and cleaned before the statistical analysis and the study database was locked to prevent any further changes, and to ensure data consistency and integrity for the statistical reporting and analysis.
Sample size calculation:
No statistical sample size calculation was performed a priori, and sample size was equal to the number of patients admitted to the participant's ICUs with confirmed COVID-19 during the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive critically ill patients admitted to ICU with severe SARS-CoV-2 infection | – | –Consecutive adult patients (> 16 years) with laboratory confirmed SARS-CoV-2 infection, detected by RT-PCR positive test of nasopharyngeal, oropharyngeal , swab or invasive respiratory samples according to the WHO recommendations. The follow-up of patients was to ICU discharge or death whichever occurred first. No interventions will be made. Only anonymized demographic data, clinical data, laboratory data and ventilatory support data will be collected. There is no standardized pharmacological treatment protocol. Only basic data are collected about the different treatments administered by the attending physician. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients with community-acquired pneumonia due to SARS-CoV-2 infection
Key inclusion criteria (2 listed)
- Severe community-acquired pneumonia due SARS CoV-2 infection and acute respiratory failure with microbiological confirmation (RT-PCR) according international guidelines
- Age >= 16 years without upper limit
Key exclusion criteria (2 listed)
- Age < 16 years
- Patients with SARS-CoV-2 infection without acute respiratory failure
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
Epidemiologic and Clinical Characteristics and risk factors for ICU mortality in critically ill patients with COVID-19 in Spain
Time frame: Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge
To determine demographics and clinical factors associated with ICU mortality at days-28 and ICU discharge
2 secondary outcomes
Support respiratory type and prognosis
Time frame: Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge
Comorbidities and prognosis
Time frame: Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Background: PubMed 32758659Berenguer J, Ryan P, Rodriguez-Bano J, Jarrin I, Carratala J, Pachon J, Yllescas M, Arriba JR; COVID-19@Spain Study Group; Fundacion SEIMC-GESIDA; Hospital General Universitario Gregorio Maranon; Hospital Universitario La Paz; Hospital Infanta Leonor; Complejo Hospitalario Virgen de la Salud; Hospital Universitario Rafael Mendez; Hospital Universitario de Cruces; Hospital de Melilla; Hospital San Eloy de Barakaldo; Hospital Universitario Central de Asturias; Hospital General Universitario de Alicante; Hospital Virgen de la Victoria; Hospital Universitario Puerto Real; EOXI Pontevedra e Salnes; Hospital de Figueres; Hospital Sant Jaume de Calella; Hospital del Mar; Hospital Virgen de la Arrixaca; Hospital de Can Misses; Hospital de Sagunto; Hospital Clinico San Cecilio; Hospital Universitario Principe de Asturias; Parc Sanitari Sant Joan de Deu; Hospital Nuestra Senora de Gracia; HC Marbella Internacional Hospital; Hospital La Princesa; Hospital Josep Trueta; Hospital Dos de Maig; Hospital Arnau de Vilanova-Lliria; Hospital General Universitario de Elche; Hospital Clinico Universitario de Valencia; Complejo Asistencial de Avila; Hospital Comarcal de Alcaniz; Hospital Universitario Marques de Valdecilla; Hospital Quiron-Salud de Torrevieja; Hospital Universitario Miguel Servet; SCIAS, Hospital de Barcelona; Fundacion Hospital Universitario Alcorcon; Hospital Alvaro Cunqueiro; Complejo Asistencial Universitario de Salamanca; Hospital Universitario Severo Ochoa; Hospital CIMA-Sanitas; Hospital HLA Inmaculada; Hospital Universitario Rio Hortega; Hospital de Guadalajara; Hospital Universitario Infanta Sofia; Hospital Comarcal de Blanes; Hospital Universitari de Tarragona Joan XXIII; Hospital Universitario Basurto; Hospital Universitario de Canarias; Hospital Universitario de Gran Canaria Dr Negrin; Hospital Son Espases; Hospital Universitario de Mostoles; Complejo Hospitalario Universitario A Coruna; Hospital Costa del Sol; Hospital Clinico Universitario Lozano Blesa; Hospital Mutua de Terrassa; Hospital de la Plana; Hospital Virgen de la Concha-Complejo Asistencial de Zamora; Complejo Hospitalario Universitario Insular Materno-Infantil; Hospital de la Marina Baixa; Hospital Universitario Virgen Macarena; Hospital Universitari de Bellvitge; Hospital Universitario y Politecnico la Fe; Hospital Universitario del Vinalopo; Hospital de Sabadell (Parc Tauli); Hospital Clinic de Barcelona; Hospital Universitario de la Ribera; Fundacion Jimenez Diaz; Hospital Clinico Universitario de Valladolid; Hospital Clinico San Carlos; Hospital Santa Creu i Sant Pau; Clinica Universitaria de Navarra-Campus Madrid; Hospital Son Llatzer; Hospital General de la Defensa Gomez Ulla; Hospital Universitario de Alava; Hospital Santos Reyes; Hospital Dr Jose Molina Orosa; Hospital Vall d'Hebron; Hospital Universitario Rey Juan Carlos; Complejo Hospitalario Universitario Santa Lucia; Hospital Santa Barbara; Complejo Hospitalario Universitario de Ferrol; Hospital de l'Esperit Sant; Hospital Universitario los Arcos del Mar Menor; Hospital HLA Universitario Moncloa; Hospital Virgen del Puerto; Hospital Marina Salud de Denia; Hospital Universitario de Jerez; Hospital Reina Sofia de Tudela; Hospital Clinico Universitario de Santiago de Compostela; Hospital Universitario del Henares; Hospital Universitario Lucus Augusti; Hospital de Donostia; Hospital de Urduliz Alfredo Espinosa; Hospital de Mendaro; Hospital Juan Ramon Jimenez; Hospital de Tortosa Virgen de la Cinta; Hospital Riotinto; Hospital Vega Baja; Hospital Puerta de Hierro; Hospital Universitario de Getafe; Hospital General de la Palma; Hospital El Bierzo; Fundacion Hospital de Calahorra; Hospital Alto Deba; Hospital Universitario San Juan de Alicante; Hospital de Guadarrama; Hospital Universitario de Jaen; Hospital de Mataro; Hospital de Palamos; Hospital Universitario de Valme; Clinica Universitaria de Navarra-Campus Navarra; Hospital Clinica Benidorm; Hospital Doce de Octubre; Hospital Universitario Virgen del Rocio; Hospital Universitario Ramon y Cajal; Hospital Universitario San Pedro; Hospital Quiron A Coruna; HM Sanchinarro; Hospital Francesc de Borja; Complejo Hospitalario Universitario Nuestra Senora de La Candelaria; Hospital Universitario HM Monteprincipe; Hospital Universitario HM Puerta del Sur; Hospital Universitario HM Torrelodones; Hospital Universitario HM Madrid; Hospital Don Benito-Villanueva de la Serena; Hospital de Viladecans; Centro Nacional de Epidemiologia. Characteristics and predictors of death among 4035 consecutively hospitalized patients with COVID-19 in Spain. Clin Microbiol Infect. 2020 Nov;26(11):1525-1536. doi: 10.1016/j.cmi.2020.07.024. Epub 2020 Aug 4.
- Background: PubMed 33632764Berenguer J, Borobia AM, Ryan P, Rodriguez-Bano J, Bellon JM, Jarrin I, Carratala J, Pachon J, Carcas AJ, Yllescas M, Arribas JR; COVID-19@Spain and COVID@HULP Study Groups. Development and validation of a prediction model for 30-day mortality in hospitalised patients with COVID-19: the COVID-19 SEIMC score. Thorax. 2021 Sep;76(9):920-929. doi: 10.1136/thoraxjnl-2020-216001. Epub 2021 Feb 25.
- Results publication: PubMed 33588914Rodriguez A, Ruiz-Botella M, Martin-Loeches I, Jimenez Herrera M, Sole-Violan J, Gomez J, Bodi M, Trefler S, Papiol E, Diaz E, Suberviola B, Vallverdu M, Mayor-Vazquez E, Albaya Moreno A, Canabal Berlanga A, Sanchez M, Del Valle Ortiz M, Ballesteros JC, Martin Iglesias L, Marin-Corral J, Lopez Ramos E, Hidalgo Valverde V, Vidaur Tello LV, Sancho Chinesta S, Gonzales de Molina FJ, Herrero Garcia S, Sena Perez CC, Pozo Laderas JC, Rodriguez Garcia R, Estella A, Ferrer R; COVID-19 SEMICYUC Working Group. Deploying unsupervised clustering analysis to derive clinical phenotypes and risk factors associated with mortality risk in 2022 critically ill patients with COVID-19 in Spain. Crit Care. 2021 Feb 15;25(1):63. doi: 10.1186/s13054-021-03487-8.
- Derived from this study: PubMed 37106321Manrique S, Claverias L, Magret M, Masclans JR, Bodi M, Trefler S, Canadell L, Diaz E, Sole-Violan J, Bisbal-Andres E, Natera RG, Moreno AA, Vallverdu M, Ballesteros JC, Socias L, Vidal FG, Sancho S, Martin-Loeches I, Rodriguez A. Timing of intubation and ICU mortality in COVID-19 patients: a retrospective analysis of 4198 critically ill patients during the first and second waves. BMC Anesthesiol. 2023 Apr 27;23(1):140. doi: 10.1186/s12871-023-02081-5.
- Spanisho Society of Critical Care webLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Alejandro Rodriguez Oviedo, MD,PhD,MsC study director
Hospital Universitari de Tarragona Joan XXIII
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 SARS-CoV2 Infection, run by Hospital Universitari Joan XXIII de Tarragona. 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 2 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. 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 Alejandro Rodríguez Oviedo, MD,PhD,MsC (+34977295818, ahr1161@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiologic and Clinical Characteristics and risk factors for ICU mortality in critically ill patients with COVID-19 in Spain (time frame: Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge). 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 NCT04948242, which also lists 4 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 20 Apr 2023.