Coronavirus InfectionsMexCOVID-19NCT04336345
Outcomes of Patients With COVID-19 in the Intensive Care Unit
An observational study of Coronavirus Infections and COVID-19, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 2 sites in Mexico.
Trial summary
The objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit. A Multicenter Observational Study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infections, COVID-19, Viral Pneumonia Human Coronavirus
- How many people
- 150 participants
- Where
- 2 sitesMexico
- Study dates
- 1 Apr 2020to 4 Jun 2020
- How long will I take part?
- 1 Month
- 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: Critically ill patients aged over 18 years with a positive for SARS-CoV-2 result required admission to an intensive care unit or critical care in other areas of the hospital (critical care surge capacity).
Who may be able to join
- Confirmed case: Critically ill patient who meets the operational definition of a suspected case and who has a confirmed diagnosis by the National Network of Public Health Laboratories recognized by the Institute of Epidemiological Diagnosis and Reference (Indre) (Mexico).
Who cannot join
- If a negative for SARS-CoV-2 result is obtained from a critically ill patient with a high index of suspicion for COVID-19 virus infection.
- Patients who had participated in another observational study in the last 30 days prior to inclusion.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
All centres from Mexico willing to contribute are Welcome.
México
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14000
About this study
Official title: Outcomes of Patients With COVID-19 in the Intensive Care Unit: A National Observational Study (Mexico COVID-19 ICU Study)
The objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit.
A Multicenter Observational Study.
Read the detailed description
As of 23 March 2020, a cumulative total of 332,930 confirmed cases of coronavirus disease 2019 (COVID-19) were reported in 189 countries and territories worldwide. As of this time, there had been 367 total confirmed cases of COVID-19, including four deaths in Mexico. The clinical manifestations of patients with COVID-19 are wide, asymptomatic infection, mild upper respiratory tract illness, and approximately 5% of critically ill patients with COVID-19 have presented rapidly progressive respiratory failure, development of acute respiratory distress syndrome (ARDS), and intensive care unit (ICU) admission. On March 24, 2020, the Secretary of Health of Mexico, formally declared the beginning of phase 2. It has been estimated that many confirmed cases of COVID-19 would occur, thus would result in a significant increase of hospital and ICU admissions.
- Keywords
- Intensive care unit, Critical care, Outcomes, Epidemiology
- Medical subject headings
- Coronavirus Infections, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Mortality 30 days following hospital admission
Measured: 30 days
Secondary outcomes (1)
Length of stay in the intensive care unit
The number of calendar days from the day of admission (counted as 1 day) to day of intensive care unit discharge
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Apr 2020
- Study completion4 Jun 2020
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 Coronavirus InfectionsStudies 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
- Cross-sectional
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvio A. Ñamendys-Silva, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Silvio A. Ñamendys-Silva, MD, MSc, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranGuillermo Dominguez-Cherit, MD, Study director, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranEduardo Rivero-Sigarroa, MD, Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336345
- Sponsor's protocol ID
- 3336
- Acronym
- MexCOVID-19
- Status last verified
- Oct 2020
- First submitted
- 2 Apr 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All IPD that underlie could results in a publication.
Publications
Namendys-Silva SA, Alvarado-Avila PE, Dominguez-Cherit G, Rivero-Sigarroa E, Sanchez-Hurtado LA, Gutierrez-Villasenor A, Romero-Gonzalez JP, Rodriguez-Bautista H, Garcia-Briones A, Garnica-Camacho CE, Cruz-Ruiz NG, Gonzalez-Herrera MO, Garcia-Guillen FJ, Guerrero-Gutierrez MA, Salmeron-Gonzalez JD, Romero-Gutierrez L, Canto-Castro JL, Cervantes VH; Mexico COVID-19 Critical Care Collaborative Group. Outcomes of patients with COVID-19 in the intensive care unit in Mexico: A multicenter observational study. Heart Lung. 2021 Jan-Feb;50(1):28-32. doi: 10.1016/j.hrtlng.2020.10.013. Epub 2020 Oct 21.
PubMed 33138974
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Patients With COVID-19 in the Intensive Care Unit: A National Observational Study (Mexico COVID-19 ICU Study)
- ClinicalTrials.gov ID
- NCT04336345
- Acronym / sponsor ID
- MexCOVID-19 / 3336
- Keywords
- Intensive care unit, Critical care, Outcomes, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 7 Apr 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 objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit.
A Multicenter Observational Study.
Detailed description
As of 23 March 2020, a cumulative total of 332,930 confirmed cases of coronavirus disease 2019 (COVID-19) were reported in 189 countries and territories worldwide. As of this time, there had been 367 total confirmed cases of COVID-19, including four deaths in Mexico. The clinical manifestations of patients with COVID-19 are wide, asymptomatic infection, mild upper respiratory tract illness, and approximately 5% of critically ill patients with COVID-19 have presented rapidly progressive respiratory failure, development of acute respiratory distress syndrome (ARDS), and intensive care unit (ICU) admission. On March 24, 2020, the Secretary of Health of Mexico, formally declared the beginning of phase 2. It has been estimated that many confirmed cases of COVID-19 would occur, thus would result in a significant increase of hospital and ICU admissions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients aged over 18 years with a positive for SARS-CoV-2 result required admission to an intensive care unit or critical care in other areas of the hospital (critical care surge capacity).
Key inclusion criteria (1 listed)
- Confirmed case: Critically ill patient who meets the operational definition of a suspected case and who has a confirmed diagnosis by the National Network of Public Health Laboratories recognized by the Institute of Epidemiological Diagnosis and Reference (Indre) (Mexico).
Key exclusion criteria (2 listed)
- If a negative for SARS-CoV-2 result is obtained from a critically ill patient with a high index of suspicion for COVID-19 virus infection.
- Patients who had participated in another observational study in the last 30 days prior to inclusion.
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
Hospital mortality
Time frame: 30 days
Mortality 30 days following hospital admission
1 secondary outcome
Length of stay in the intensive care unit
Time frame: Through study completion, an average of 30 days
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 10 Nov 2020.
- Results publication: PubMed 33138974Namendys-Silva SA, Alvarado-Avila PE, Dominguez-Cherit G, Rivero-Sigarroa E, Sanchez-Hurtado LA, Gutierrez-Villasenor A, Romero-Gonzalez JP, Rodriguez-Bautista H, Garcia-Briones A, Garnica-Camacho CE, Cruz-Ruiz NG, Gonzalez-Herrera MO, Garcia-Guillen FJ, Guerrero-Gutierrez MA, Salmeron-Gonzalez JD, Romero-Gutierrez L, Canto-Castro JL, Cervantes VH; Mexico COVID-19 Critical Care Collaborative Group. Outcomes of patients with COVID-19 in the intensive care unit in Mexico: A multicenter observational study. Heart Lung. 2021 Jan-Feb;50(1):28-32. doi: 10.1016/j.hrtlng.2020.10.013. Epub 2020 Oct 21.
- Individual participant dataSharing planned: Undecided. All IPD that underlie could results in a 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.
Silvio A. Ñamendys-Silva, MD, MSc principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Guillermo Dominguez-Cherit, MD study director
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Eduardo Rivero-Sigarroa, MD study chair
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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 Coronavirus Infections and COVID-19, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 2 sites in Mexico.
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 1 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 10 Nov 2020. 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 Mexico. 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?
Hospital mortality (time frame: 30 days). 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 NCT04336345, 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 10 Nov 2020.