COVID-19 Acute Respiratory Distress SyndromePRoVAcT-COVIDNCT05954351
PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients.
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients. An observational study of ventilation practice and adjunctive therapies in critically ill, invasively ventilated COVID-19 patients during the first and second surge of COVID-19 in the Netherlands. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- How many people
- 2,465 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2022to 1 Jul 2023
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: invasively ventilation COVID-19 patients, admitted between March 1 to June 1, 2020, and October 1 to December 31, 2020, to one of the 22 participating ICU's in the Netherlands.
Who may be able to join
- receiving invasive ventilation or high-flow nasal oxygen for COVID-19 for SARS-CoV-2
- admitted to one of the ICUs of the participating hospitals
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
About this study
Official title: PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients; What is the Optimal Ventilation Strategy in Critically Ill COVID-19 Patients, in Particular PEEP and the Moment of Switch to Pressure Support?
PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients. An observational study of ventilation practice and adjunctive therapies in critically ill, invasively ventilated COVID-19 patients during the first and second surge of COVID-19 in the Netherlands.
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Measured: 90 days from inclusion
Secondary outcomes (4)
Duration of ventilation
Measured: 90 days from inclusion
28-day ventilator free days
Measured: 90 days from inclusion
28-day, 90-day mortality
Measured: 90 days from inclusion
ICU and hospital length of stay
Measured: 90 days from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 May 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 2,465 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954351
- Sponsor's protocol ID
- PRoVAcT-COVID
- Acronym
- PRoVAcT-COVID
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients; What is the Optimal Ventilation Strategy in Critically Ill COVID-19 Patients, in Particular PEEP and the Moment of Switch to Pressure Support?
- ClinicalTrials.gov ID
- NCT05954351
- Acronym / sponsor ID
- PRoVAcT-COVID / PRoVAcT-COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,465 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 20 Jul 2023 (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.
PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients. An observational study of ventilation practice and adjunctive therapies in critically ill, invasively ventilated COVID-19 patients during the first and second surge of COVID-19 in the Netherlands.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- invasively ventilation COVID-19 patients, admitted between March 1 to June 1, 2020, and October 1 to December 31, 2020, to one of the 22 participating ICU's in the Netherlands.
Key inclusion criteria (2 listed)
- receiving invasive ventilation or high-flow nasal oxygen for COVID-19 for SARS-CoV-2
- admitted to one of the ICUs of the participating hospitals
Key exclusion criteria (1 listed)
- none
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
ICU mortality
Time frame: 90 days from inclusion
4 secondary outcomes
Duration of ventilation
Time frame: 90 days from inclusion
28-day ventilator free days
Time frame: 90 days from inclusion
28-day, 90-day mortality
Time frame: 90 days from inclusion
ICU and hospital length of stay
Time frame: 90 days from inclusion
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 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Respiratory Distress Syndrome, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 3 Jul 2024. 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 Netherlands. 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?
ICU mortality (time frame: 90 days from inclusion). 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 3 Jul 2024.