Acute Respiratory Distress SyndromeNCT04457505
One Year Follow-ups of Patients Admitted to Spanish Intensive Care Units Due to COVID-19
An observational study of Acute Respiratory Distress Syndrome and Severe Pneumonia, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 31 sites in Spain.
Trial summary
The latest epidemiological data published from Chine reports that up to 30% of hospital-admitted patients required admission to intensive care units (ICU). The cause for ICU admission for most patients is very severe respiratory failure; 80% of the patients present with severe acute respiratory distress syndrome… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Severe Pneumonia, Respiratory Failure
- How many people
- 8,500 participants
- Where
- 31 sitesSpain
- Study dates
- 8 May 2020to 31 Dec 2021
- How long will I take part?
- 1 Year
- 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: Patients admitted to Spanish ICUs.
Who may be able to join
- 1. Laboratory-confirmed COVID-19 infection with either real-time PCR or Next Generation Sequencing (NGS)
- 2. Admission to intensive care unit
Who cannot join
- 1. Patients admitted to COVID-19-negative ICU
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Spain31 sites
Hospital Universitario Sant Joan d'Alacant
Alicante, 03550
Clínica Sagrada Família
Barcelona, 08022
Hospital Sagrat Cor
Barcelona, 08029
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Vall d'Hebron University Hospital, Barcelona
Barcelona, 08035
Hospital Clinic
Barcelona, 08036
Hospital Burgos
Burgos, 09006
Hospital Infanta Margarita de Cabra
Cabra, Córdoba, 14940
Hospital San Pedro de Alcantara
Cáceres, 10003
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital de León
León, 24008
Hospital Arnau de Vilanova Lleida
Lleida, 25198
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27003
Hospital Infanta Leonor de Madrid
Madrid, 28031
Hospital Universitario La Paz
Madrid, 28046
Hospital de Mataró
Mataró, Barcelona, 08304
Complexo Hospitalario Universitario de Ourense
Ourense, 32005
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 30011
Complejo Asistencial Universitario de Palencia
Palencia, 34005
Hospital Son Llatzer
Palma de Mallorca, Mallorca, 07198
Hospital Montecelo
Pontevedra, 36071
Hospital Universitario Salamanca
Salamanca, 37007
Hospital General de Cataluña
Sant Cugat del Vallès, Barcelona, 08195
Hospital Universitari Virgen de Valme
Seville, 41014
Hospital Universitari de Tarragona Joan XXIII
Tarragona, 43005
Hospital Verge de la Cinta
Tortosa, Tarragona, 43500
Hospital Clínic Universitari de València
Valencia, 46010
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Hospital Universitario Valladolid
Valladolid, 47003
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36213
Hospital Nuestra Señora de Gracia
Zaragoza, 50004
About this study
Official title: Risk Factors, Personalized Prognoses and 1-year Follow-ups of Patients Admitted to Spanish Intensive Care Units Due to COVID-19
The latest epidemiological data published from Chine reports that up to 30% of hospital-admitted patients required admission to intensive care units (ICU). The cause for ICU admission for most patients is very severe respiratory failure; 80% of the patients present with severe acute respiratory distress syndrome (SARS) that requires protective mechanical ventilation.
Five percent of patients with SARS require extracorporeal circulation (ECMO) techniques. Global mortality data has been thus far reported in different individual publications from China. Without accounting for those patients still admitted to hospital, bona fide information (from a hospital in Wuhan) received by the PI of this project estimates that mortality of hospitalized patients is more than 10%. Evidently, mortality is concentrated in patients admitted to the ICU and those patients who require mechanical ventilation and present with SARS. As data in China was globally reported, risk factors and prognosis of patients with and without SARS who require mechanical ventilation are not definitively known. The efficacy of different treatments administered empirically or based on small, observation studies is also not known. With many still admitted at the time of publication, a recent study in JAMA about 1500 patients admitted to the ICU in the region of Lombardy (Italy) reported a crude mortality rate of 25%. The data published until the current date is merely observational, prospective or retrospective. Data has not been recorded by analysis performed with artificial intelligence (machine learning) in order to report much more personalized results. Furthermore, as it concerns patients admitted to the ICU who survive, respiratory and cardiovascular consequences, as well as quality of living are completely unknown.
Read more
The study further aims to investigate quality of life and different respiratory and cardiovascular outcomes at 6 months, as well as crude mortality within 1 year after discharge of patients with COVID-19 who survive following ICU admission. Lastly, with the objective to help personalize treatment in accordance with altered biological pathways in each patient, two types of studies will be performed: 1) epigenetics and 2) predictive enrichment of biomarkers in plasma.
Hypothesis
- A significant percentage of patients (20%) admitted to the hospital with COVID-19 infection is expected to require ICU admission, and need mechanical ventilation (80%) and, in a minor percentage (5%), ECMO.
- Patients who survive an acute episode during ICU hospitalization will have a yearly accumulated mortality of 40%. Those who then survive will have respiratory consequences, cardiovascular complications and poor quality of life (6 months).
Read the detailed description
Objective and Purpose of Study
- The main objective is to determine risks factors and prognosis of patients with COVID-19 infection who have been admitted to Spanish ICUs between the beginning and end of the pandemic in Spain. Special attention will be placed on identifying differential expression of prognostic factors based on sex.
- The second objective is to perform a follow-up of patients within 6 months after discharge from ICU and hospital in order to determine mortality (including at 1-year mark), functional respiratory and cardiovascular consequences, and quality of life.
- The third objective is to perform an epigenetic study in cases, in which a blood sample can be drawn. The aim of such undertaking is to define molecular signatures in liquid biopsies that can provide information regarding prognosis, and treatment monitoring and response to therapy.
- Lastly, predictive ability of response to therapy and mortality will be assessed from a panel of protein biomarkers that participate in key physiological pathways of the disease's pathogenesis. This could, in turn, help select prospective treatments with greater potential of being successful in each patient.
Principal and Secondary Variables
- Prior epidemiological data of the patient
- Biological and clinical data, including treatment administered upon hospital admission
- Biological and clinical data, including treatments administered upon and during ICU admission until either discharge from ICU or hospital, or death
- Specific data regarding artificial ventilation and ECMO since the beginning, as well as sequentially, from intubation to either extubation or death
- Biological and clinical data upon hospital discharge
- Clinical follow-up of patients who survive within 6 months, including: functional respiratory tests, echocardiograms and surveys regarding quality of life
- Intrahospital and intra-ICU mortality will be registered at 28- and 90-day marks, as well as within 6 months and 1 year
- 1000 blood samples will be drawn for the epigenetic study The molecular profile of a non-coding RNA (ncRNA), specifically the microRNA (miRNA) pattern in liquid biopsy, will be analyzed. A circulating miRNA signature is closer to the phenotype than genomic markers and can provide information regarding epigenetic regulation, cell activation, tissue repair, and metabolic processes in addition to that afforded by clinical predictors and classic risk factors. miRNAs offer appropriate biochemical properties that are highly stable; have a long half-life in biological samples used in clinical laboratories (serum/plasma); can be efficiently and relatively rapidly quantified with high sensitivity and specificity by RT-qPCR; and can serve as a profitable tool for the assessment of risks and disease control.
All of these characteristics have led distinct authors to propose the clinical application of miRNA in either the short or medium term.
The experimental design comprises two phases. In the first approximation, a screening of non-coding RNA (ncRNA) will be performed in a sub-population of patients (n=200). The number of samples surpasses the quantity recommended for this type of studies. (Schurch y cols., RNA, 2016). A quotation will be requested for the screening of ncRNA by HTG EdgeSeq miRNA Whole Transcriptome Assay system (HTG). Using next generation sequencing (NGS), this method allows for the quantification of 2083 human candidates. All of the procedure steps will be completed in suitable physical locations in accordance with code OP No. 0028. All of the samples will be prepared in accordance with code No. 0036.
Screening results will be validated in the validation cohort (n=800) with RT-qPCR, a gold-standard technique. The budget includes material necessary for RNA extraction (miRNeasy Serum/Plasma isolation kits, Qiagen; spike-in; carrier RNA; consumables) and expression quantification of ncRNA in biofluids (RT-qPCR miRCURY LNA Universal RT microRNA PCR System kits, Qiagen; endogenous controls; consumables. Studies will be carried out at the TRRM Group facilities in the IRBLleida. The laboratory has the necessary team and material to isolate and quantify RNA, and store reagents and samples (cold stores, freezers of 20ºC and -80ºC).
9.- For the study of prognostic biomarkers, concentration of biomarkers in plasma that are key to potentially useful drugs' mechanism of action in this disease will be assessed. This quantification could provide guidance on drug usage (lymphocyte count will be obtained from a blood count):
- Medical subject headings
- Respiratory Distress Syndrome, Pneumonia, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
One year mortality
People who died after one year of follow up
Measured: At 12 months of ICU admission
Six month mortality
People who died after one year of follow up
Measured: At 6 month of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start8 May 2020
- Primary completion30 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- 8,500 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Sponsor type
- Other government
- Collaborators
- Barcelona Supercomputing Center, Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- Antoni Torres, PhD, Principal investigator, Spanish Research Center for Respiratory Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457505
- Sponsor's protocol ID
- CIBERESUCICOVID
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2020
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD anonymized that underlie results in a publication will be available after publication.
Publications
Estella A, Tedim AP, Hader A, Ortega A, Garcia-Mateo N, de la Fuente A, Postigo T, Recuerda Nunez M, Sanchez Calvo JM, de Gonzalo-Calvo D, Torres A, Barbe F, Deinhardt-Emmer S, Bermejo-Martin JF. Poor control of pulmonary viral replication in COVID-19 patients with early respiratory failure. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101779. doi: 10.1016/j.accpm.2026.101779. Epub 2026 Feb 25.
PubMed 41759657Wendel-Garcia PD, Ceccato A, Motos A, Franch-Llasat D, Perez-Moreno MO, Domenech-Spanedda MF, Chamarro-Marti E, Ferrer R, Fernandez-Barat L, Riera J, Alvarez-Napagao S, Penuelas O, Lorente JA, Almansa R, Gabarrus A, de Gonzalo-Calvo D, Gonzalez J, Anon JM, Barbera C, Barberan J, Blandino-Ortiz A, Bustamante-Munguira E, Caballero J, Carbajales-Perez C, Carbonell N, Catalan-Gonzalez M, Barral-Segade P, Manez R, de la Torre MC, Diaz E, Estella A, Gallego E, Garcia-Garmendia JL, Garnacho-Montero J, Amaya-Villar R, Gomez JM, Huerta A, Jorge-Garcia RN, Loza-Vazquez A, Marin-Corral J, Martin-Delgado MC, de la Gandara AM, Martinez-Varela IY, Lopez-Messa J, Muniz-Albaiceta G, Novo MA, Penasco Y, Pozo-Laderas JC, Ricart P, Sanchez-Miralles A, Sancho S, Socias L, Sole-Violan J, Suarez-Sipmann F, Tamayo L, Trenado J, Barbe F, Torres A, Roche-Campo F; CIBERESUCICOVID Investigators. Empirical antibiotic therapy improves outcomes in mechanically ventilated patients with COVID-19: An emulated targeted trial within a prospective, multicentre cohort study. J Infect. 2025 Feb;90(2):106411. doi: 10.1016/j.jinf.2025.106411. Epub 2025 Jan 13.
PubMed 39814268Garcia-Hidalgo MC, Gonzalez J, Benitez ID, Carmona P, Santisteve S, Perez-Pons M, Moncusi-Moix A, Gort-Paniello C, Rodriguez-Jara F, Molinero M, Belmonte T, Torres G, Labarca G, Nova-Lamperti E, Caballero J, Bermejo-Martin JF, Ceccato A, Fernandez-Barat L, Ferrer R, Garcia-Gasulla D, Menendez R, Motos A, Penuelas O, Riera J, Torres A, Barbe F, de Gonzalo-Calvo D; CIBERESUCICOVID Project (COV20/00110, ISCIII). Identification of circulating microRNA profiles associated with pulmonary function and radiologic features in survivors of SARS-CoV-2-induced ARDS. Emerg Microbes Infect. 2022 Dec;11(1):1537-1549. doi: 10.1080/22221751.2022.2081615.
PubMed 35603455
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors, Personalized Prognoses and 1-year Follow-ups of Patients Admitted to Spanish Intensive Care Units Due to COVID-19
- ClinicalTrials.gov ID
- NCT04457505
- Acronym / sponsor ID
- CIBERESUCICOVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,500 participants (actual)
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)Other government
- Collaborators
- Barcelona Supercomputing Center, Carlos III Health Institute
- Study start
- 8 May 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Jul 2020 (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.
The latest epidemiological data published from Chine reports that up to 30% of hospital-admitted patients required admission to intensive care units (ICU). The cause for ICU admission for most patients is very severe respiratory failure; 80% of the patients present with severe acute respiratory distress syndrome (SARS) that requires protective mechanical ventilation.
Five percent of patients with SARS require extracorporeal circulation (ECMO) techniques. Global mortality data has been thus far reported in different individual publications from China. Without accounting for those patients still admitted to hospital, bona fide information (from a hospital in Wuhan) received by the PI of this project estimates that mortality of hospitalized patients is more than 10%. Evidently, mortality is concentrated in patients admitted to the ICU and those patients who require mechanical ventilation and present with SARS. As data in China was globally reported, risk factors and prognosis of patients with and without SARS who require mechanical ventilation are not definitively known. The efficacy of different treatments administered empirically or based on small, observation studies is also not known. With many still admitted at the time of publication, a recent study in JAMA about 1500 patients admitted to the ICU in the region of Lombardy (Italy) reported a crude mortality rate of 25%. The data published until the current date is merely observational, prospective or retrospective. Data has not been recorded by analysis performed with artificial intelligence (machine learning) in order to report much more personalized results. Furthermore, as it concerns patients admitted to the ICU who survive, respiratory and cardiovascular consequences, as well as quality of living are completely unknown.
The study further aims to investigate quality of life and different respiratory and cardiovascular outcomes at 6 months, as well as crude mortality within 1 year after discharge of patients with COVID-19 who survive following ICU admission. Lastly, with the objective to help personalize treatment in accordance with altered biological pathways in each patient, two types of studies will be performed: 1) epigenetics and 2) predictive enrichment of biomarkers in plasma.
Hypothesis
- A significant percentage of patients (20%) admitted to the hospital with COVID-19 infection is expected to require ICU admission, and need mechanical ventilation (80%) and, in a minor percentage (5%), ECMO.
- Patients who survive an acute episode during ICU hospitalization will have a yearly accumulated mortality of 40%. Those who then survive will have respiratory consequences, cardiovascular complications and poor quality of life (6 months).
Detailed description
Objective and Purpose of Study
- The main objective is to determine risks factors and prognosis of patients with COVID-19 infection who have been admitted to Spanish ICUs between the beginning and end of the pandemic in Spain. Special attention will be placed on identifying differential expression of prognostic factors based on sex.
- The second objective is to perform a follow-up of patients within 6 months after discharge from ICU and hospital in order to determine mortality (including at 1-year mark), functional respiratory and cardiovascular consequences, and quality of life.
- The third objective is to perform an epigenetic study in cases, in which a blood sample can be drawn. The aim of such undertaking is to define molecular signatures in liquid biopsies that can provide information regarding prognosis, and treatment monitoring and response to therapy.
- Lastly, predictive ability of response to therapy and mortality will be assessed from a panel of protein biomarkers that participate in key physiological pathways of the disease's pathogenesis. This could, in turn, help select prospective treatments with greater potential of being successful in each patient.
Principal and Secondary Variables
- Prior epidemiological data of the patient
- Biological and clinical data, including treatment administered upon hospital admission
- Biological and clinical data, including treatments administered upon and during ICU admission until either discharge from ICU or hospital, or death
- Specific data regarding artificial ventilation and ECMO since the beginning, as well as sequentially, from intubation to either extubation or death
- Biological and clinical data upon hospital discharge
- Clinical follow-up of patients who survive within 6 months, including: functional respiratory tests, echocardiograms and surveys regarding quality of life
- Intrahospital and intra-ICU mortality will be registered at 28- and 90-day marks, as well as within 6 months and 1 year
- 1000 blood samples will be drawn for the epigenetic study The molecular profile of a non-coding RNA (ncRNA), specifically the microRNA (miRNA) pattern in liquid biopsy, will be analyzed. A circulating miRNA signature is closer to the phenotype than genomic markers and can provide information regarding epigenetic regulation, cell activation, tissue repair, and metabolic processes in addition to that afforded by clinical predictors and classic risk factors. miRNAs offer appropriate biochemical properties that are highly stable; have a long half-life in biological samples used in clinical laboratories (serum/plasma); can be efficiently and relatively rapidly quantified with high sensitivity and specificity by RT-qPCR; and can serve as a profitable tool for the assessment of risks and disease control.
All of these characteristics have led distinct authors to propose the clinical application of miRNA in either the short or medium term.
The experimental design comprises two phases. In the first approximation, a screening of non-coding RNA (ncRNA) will be performed in a sub-population of patients (n=200). The number of samples surpasses the quantity recommended for this type of studies. (Schurch y cols., RNA, 2016). A quotation will be requested for the screening of ncRNA by HTG EdgeSeq miRNA Whole Transcriptome Assay system (HTG). Using next generation sequencing (NGS), this method allows for the quantification of 2083 human candidates. All of the procedure steps will be completed in suitable physical locations in accordance with code OP No. 0028. All of the samples will be prepared in accordance with code No. 0036.
Screening results will be validated in the validation cohort (n=800) with RT-qPCR, a gold-standard technique. The budget includes material necessary for RNA extraction (miRNeasy Serum/Plasma isolation kits, Qiagen; spike-in; carrier RNA; consumables) and expression quantification of ncRNA in biofluids (RT-qPCR miRCURY LNA Universal RT microRNA PCR System kits, Qiagen; endogenous controls; consumables. Studies will be carried out at the TRRM Group facilities in the IRBLleida. The laboratory has the necessary team and material to isolate and quantify RNA, and store reagents and samples (cold stores, freezers of 20ºC and -80ºC).
9.- For the study of prognostic biomarkers, concentration of biomarkers in plasma that are key to potentially useful drugs' mechanism of action in this disease will be assessed. This quantification could provide guidance on drug usage (lymphocyte count will be obtained from a blood count):
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to Spanish ICUs.
Key inclusion criteria (2 listed)
- 1. Laboratory-confirmed COVID-19 infection with either real-time PCR or Next Generation Sequencing (NGS)
- 2. Admission to intensive care unit
Key exclusion criteria (1 listed)
- 1. Patients admitted to COVID-19-negative ICU
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
One year mortality
Time frame: At 12 months of ICU admission
People who died after one year of follow up
Six month mortality
Time frame: At 6 month of ICU admission
People who died after one year of follow up
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 21 Jul 2022.
- Derived from this study: PubMed 41759657Estella A, Tedim AP, Hader A, Ortega A, Garcia-Mateo N, de la Fuente A, Postigo T, Recuerda Nunez M, Sanchez Calvo JM, de Gonzalo-Calvo D, Torres A, Barbe F, Deinhardt-Emmer S, Bermejo-Martin JF. Poor control of pulmonary viral replication in COVID-19 patients with early respiratory failure. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101779. doi: 10.1016/j.accpm.2026.101779. Epub 2026 Feb 25.
- Derived from this study: PubMed 39814268Wendel-Garcia PD, Ceccato A, Motos A, Franch-Llasat D, Perez-Moreno MO, Domenech-Spanedda MF, Chamarro-Marti E, Ferrer R, Fernandez-Barat L, Riera J, Alvarez-Napagao S, Penuelas O, Lorente JA, Almansa R, Gabarrus A, de Gonzalo-Calvo D, Gonzalez J, Anon JM, Barbera C, Barberan J, Blandino-Ortiz A, Bustamante-Munguira E, Caballero J, Carbajales-Perez C, Carbonell N, Catalan-Gonzalez M, Barral-Segade P, Manez R, de la Torre MC, Diaz E, Estella A, Gallego E, Garcia-Garmendia JL, Garnacho-Montero J, Amaya-Villar R, Gomez JM, Huerta A, Jorge-Garcia RN, Loza-Vazquez A, Marin-Corral J, Martin-Delgado MC, de la Gandara AM, Martinez-Varela IY, Lopez-Messa J, Muniz-Albaiceta G, Novo MA, Penasco Y, Pozo-Laderas JC, Ricart P, Sanchez-Miralles A, Sancho S, Socias L, Sole-Violan J, Suarez-Sipmann F, Tamayo L, Trenado J, Barbe F, Torres A, Roche-Campo F; CIBERESUCICOVID Investigators. Empirical antibiotic therapy improves outcomes in mechanically ventilated patients with COVID-19: An emulated targeted trial within a prospective, multicentre cohort study. J Infect. 2025 Feb;90(2):106411. doi: 10.1016/j.jinf.2025.106411. Epub 2025 Jan 13.
- Derived from this study: PubMed 35603455Garcia-Hidalgo MC, Gonzalez J, Benitez ID, Carmona P, Santisteve S, Perez-Pons M, Moncusi-Moix A, Gort-Paniello C, Rodriguez-Jara F, Molinero M, Belmonte T, Torres G, Labarca G, Nova-Lamperti E, Caballero J, Bermejo-Martin JF, Ceccato A, Fernandez-Barat L, Ferrer R, Garcia-Gasulla D, Menendez R, Motos A, Penuelas O, Riera J, Torres A, Barbe F, de Gonzalo-Calvo D; CIBERESUCICOVID Project (COV20/00110, ISCIII). Identification of circulating microRNA profiles associated with pulmonary function and radiologic features in survivors of SARS-CoV-2-induced ARDS. Emerg Microbes Infect. 2022 Dec;11(1):1537-1549. doi: 10.1080/22221751.2022.2081615.
- Individual participant dataSharing planned: Yes. All IPD anonymized that underlie results in a publication will be available after publication.
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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.
Antoni Torres, PhD principal investigator
Spanish Research Center for Respiratory Diseases
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Severe Pneumonia, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 31 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 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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?
One year mortality (time frame: At 12 months of ICU admission). The study lists 2 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 NCT04457505, which also lists 3 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 Jul 2022.