COVID-19TetrixNCT04393324
The Critical Care Response to the COVID-19 Pandemic in Madrid
An observational study of COVID-19 and ARDS, Human, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Description of the adaptation of ICUs in the region of Madrid to que surge in demand of critical care due to COVID-19 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19, ARDS, Human
- How many people
- 2,500 participants
- Where
- 1 siteSpain
- Study dates
- 24 Apr 2020to 30 Jun 2020
- How long will I take part?
- 9 Weeks
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Critically ill patients admitted to ICUs in Madrid for COVID-19
Who may be able to join
- Admitted to ICU in Madrid with COVID-19
Who cannot join
- Admitted to ICU without COVID-19
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
Miguel Sanchez Garcia, MD. PhD, 913303223, miguelsanchez.hcsc@gmail.com
About this study
Official title: The Critical Care Resources Adaptation to the SARS-CoV-2 Pandemic in Madrid
Description of the adaptation of ICUs in the region of Madrid to que surge in demand of critical care due to COVID-19
Read the detailed description
Background
The worldwide SARS-CoV-2 pandemic has put healthcare systems under the extreme pressure, with intensive care units being faced with a previously unseen number of patients with severe respiratory failure requiring admission for endotracheal intubation and mechanical ventilation.
Methods
The study describes how the critical care resources adapted to the sudden surge of severe Covid-19 in the province of Madrid, which developed at the beginning of March 2020. The response consisted of a swift increase in ICU capacity and the relocation of patients. ICU beds were mounted outside the usual intensive care areas. Transfer of critically ill intubated patients with COVID-19 was managed in an instant messenger service group composed of representatives of 53 intensive care units and performed by the Madrid Emergency Medical Systems (EMS). The investigators will compare transferred with non-transferred patients matched for risk factors for cardiovascular and respiratory complications.
- Conditions
- COVID-19, ARDS, Human
- Keywords
- COVID-19, ARDS, Relocation, ICU capacity
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
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 |
|---|---|---|
| Transferred patients | A subgroup of Critically ill intubated patients with COVID-19 associated ARDS were transferred from overwhelmed ICUs to other with available free beds | |
| Matched Non-transferred patients | A subgroup from the global cohort, matched for risk factors will be compared with transferred patients for outcome variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
ICU mortality
Measured: 9 weeks
Secondary outcomes (1)
Length of ICU stay
From admission to discharge or death
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start24 Apr 2020
- Primary completion31 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Other
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 9 Weeks
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
- Responsible party
- Principal investigator, Miguel Sanchez Garcia, Hospital San Carlos, Madrid
- Investigators
- Miguel Sánchez García, MD, Principal investigator, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393324
- Sponsor's protocol ID
- Madrid COVID Tetrix
- Acronym
- Tetrix
- Status last verified
- May 2020
- First submitted
- 17 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Critical Care Resources Adaptation to the SARS-CoV-2 Pandemic in Madrid
- ClinicalTrials.gov ID
- NCT04393324
- Acronym / sponsor ID
- Tetrix / Madrid COVID Tetrix
- Conditions
- COVID-19, ARDS, Human
- Keywords
- COVID-19, ARDS, Relocation, ICU capacity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 19 May 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.
Description of the adaptation of ICUs in the region of Madrid to que surge in demand of critical care due to COVID-19
Detailed description
Background
The worldwide SARS-CoV-2 pandemic has put healthcare systems under the extreme pressure, with intensive care units being faced with a previously unseen number of patients with severe respiratory failure requiring admission for endotracheal intubation and mechanical ventilation.
Methods
The study describes how the critical care resources adapted to the sudden surge of severe Covid-19 in the province of Madrid, which developed at the beginning of March 2020. The response consisted of a swift increase in ICU capacity and the relocation of patients. ICU beds were mounted outside the usual intensive care areas. Transfer of critically ill intubated patients with COVID-19 was managed in an instant messenger service group composed of representatives of 53 intensive care units and performed by the Madrid Emergency Medical Systems (EMS). The investigators will compare transferred with non-transferred patients matched for risk factors for cardiovascular and respiratory complications.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 9 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transferred patients | – | –A subgroup of Critically ill intubated patients with COVID-19 associated ARDS were transferred from overwhelmed ICUs to other with available free beds |
| Matched Non-transferred patients | – | –A subgroup from the global cohort, matched for risk factors will be compared with transferred patients for outcome variables |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients admitted to ICUs in Madrid for COVID-19
Key inclusion criteria (1 listed)
- Admitted to ICU in Madrid with COVID-19
Key exclusion criteria (1 listed)
- Admitted to ICU without COVID-19
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
Mortality
Time frame: 9 weeks
ICU mortality
1 secondary outcome
Length of ICU stay
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
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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.
Miguel Sánchez García, MD principal investigator
Hospital San Carlos, Madrid
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 COVID-19 and ARDS, Human, run by Hospital San Carlos, Madrid 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 1 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: status not confirmed, as of the sponsor's last update on 28 May 2020. 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 Miguel S Sanchez Garcia, MD (+34913303223, miguelsanchez.hcsc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2020.