Covid19PRoAcT-COVIDNCT04719182
Practice of Adjunctive Treatments in Intensive Care Unit Patients With COVID-19
An observational study of Covid19 and Pneumonia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial summary
Rationale Many patients with coronavirus disease (COVID-19) need hospital admission for oxygen supplementation. A substantial number of patients need intensive care unit (ICU) admission for escalation of care. ICU doctors and nurses are struggling to provide the best care for patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Pneumonia, Thrombosis
- What is being tested?
- Adjunctive therapies
- How many people
- 1,011 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Sep 2020to 1 Apr 2021
- 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: Patients with severe coronavirus disease 2019 (COVID-19) admitted to intensive care units (ICUs) in the Netherlands between September 2020 and January 2021 (i.e. during the second surge of COVID-19 patients).
Who may be able to join
- COVID-19, confirmed with PCR; and
- Admission to one of the participating ICUs, or an emergency location that serves as an ICU during the pandemic.
Who cannot join
- Age < 18 years
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Amsterdam UMC location AMC
Amsterdam, 1105AZ
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam
About this study
Official title: Practice of Adjunctive Treatments in Intensive Care Unit Patients With Coronavirus Disease 2019 (PRoAcT-COVID) - an Observational Study in the Netherlands
Rationale Many patients with coronavirus disease (COVID-19) need hospital admission for oxygen supplementation. A substantial number of patients need intensive care unit (ICU) admission for escalation of care. ICU doctors and nurses are struggling to provide the best care for patients with COVID-19. Practice of adjunctive and supportive treatments remains uncertain.
Objective To determine and compare practice of adjunctive and supportive treatments for COVID-19 in the Netherlands, and to determine their independent associations with outcome.
Read more
Hypotheses Practice of adjunctive and supportive treatments for COVID-19 varies substantially. Adjunctive and supportive treatments have an independent association with outcome in ICU patients with COVID-19.
Study design National/international, multicenter, retrospective observational study. Study population Intensive care unit (ICU) patients with COVID-19.
Methods In this study we will collect data on diverse treatments during the first 28 days in ICU, including (a) the types of oxygen support* and awake prone positioning; (b) the types of ventilatory support, (c) rescue therapies for refractory hypoxemia during invasive ventilation (prone positioning, ventilator adjustments, continuous muscle paralysis, and extracorporeal membrane oxygenation); (d) adjunctive treatments, including thromboprophylaxis and anticoagulation, antiviral and immunomodulating therapies, and (e) experimental supportive treatments. Outcomes include duration of each adjunctive treatment, duration of ventilation, incidence of tracheostomy, duration of stay in ICU and mortality until day 90.
Study endpoints A combination of adjunctive treatments, including types of oxygen support, ventilatory support and rescue therapies for refractory hypoxemia during invasive ventilation (primary), other adjunctive and supportive treatments, tracheostomy rate; duration of ventilation and ventilator-free days and alive at day 28 (VFD-28), duration of ICU and hospital stay, and ICU, hospital and 90-day mortality.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness Retrospective collection of data regarding adjunctive treatments, and clinical endpoints is without risk for ICU patients.
*In a subset of patients we will collect granular data (every two hours) regarding oxygenation (FiO2, inspiratory tidal volume, air flow, respiratory rate, SpO2, PaO2, and PEEP) over the first 2 full calendar days of ICU admission. The primary endpoint of this sub-analysis will be the amount of oxygen used with different respiratory support interventions. The statistical analysis plan for the analysis of these data that were collected in two ICUs that participated in the national study, and one additional ICU in Spain is uploaded in the document section (filename Statistical Analysis Plan PROXY-COVID)
- Conditions
- Covid19, Pneumonia, Thrombosis, Thromboembolism, Anticoagulants; Increased, ARDS, Human
- Being tested
- Adjunctive therapies
- Keywords
- ARDS, COVID-19, Lungembolism, DVT, PPI, Adjunctive therapies, Mechanical ventilation, Prone positioning
- Medical subject headings
- COVID-19, Pneumonia, Thrombosis, Thromboembolism, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive therapiesOther
Determine and compare practice of adjunctive and supportive treatments for COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 90 days
ICU, hospital and 90-day mortality
Measured: 90 days
Ventilator-free days and alive at day 28
Measured: 28 days
ICU length of stay
Measured: 90 days
Hospital length of stay
Measured: 90 days
Secondary outcomes (6)
Proven deep vein thrombosis (DVT)
Measured: 28 days
Incidence of gastrointestinal bleeding
Measured: 28 days
Development of acute kidney injury (AKI)
Measured: 28 days
Incidence of tracheostomy
Measured: 28 days
Use of renal replacement therapy (RRT)
Measured: 28 days
Proven pulmonary embolism (PE)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Sep 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- 1,011 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719182
- Sponsor's protocol ID
- PRoAcT-COVID
- Acronym
- PRoAcT-COVID
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van der Ven FLIM, Valk CMA, Blok S, Brouwer MG, Go DM, Lokhorst A, Swart P, van Meenen DMP, Paulus F, Schultz MJ; PRoAcT-COVID study investigators. Broadening the Berlin definition of ARDS to patients receiving high-flow nasal oxygen: an observational study in patients with acute hypoxemic respiratory failure due to COVID-19. Ann Intensive Care. 2023 Jul 14;13(1):64. doi: 10.1186/s13613-023-01161-6.
PubMed 37452196Valk CMA, Swart P, Boers LS, Botta M, Bos LDJ, de Abreu MG, Hol L, Hollmann MW, Horn J, Martin-Loeches I, Mazzinari G, Myatra SN, Nijbroek SG, Rosenberg NM, Stilma W, Tsonas AM, van der Ven WH, Neto AS, Schultz MJ, Paulus F. Practice of adjunctive treatments in critically ill COVID-19 patients-rational for the multicenter observational PRoAcT-COVID study in The Netherlands. Ann Transl Med. 2021 May;9(9):813. doi: 10.21037/atm-21-764.
PubMed 34268426
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice of Adjunctive Treatments in Intensive Care Unit Patients With Coronavirus Disease 2019 (PRoAcT-COVID) - an Observational Study in the Netherlands
- ClinicalTrials.gov ID
- NCT04719182
- Acronym / sponsor ID
- PRoAcT-COVID / PRoAcT-COVID
- Conditions
- Covid19, Pneumonia, Thrombosis, Thromboembolism, Anticoagulants; Increased, ARDS, Human
- Keywords
- ARDS, COVID-19, Lungembolism, DVT, PPI, Adjunctive therapies, Mechanical ventilation, Prone positioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 22 Jan 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.
Rationale Many patients with coronavirus disease (COVID-19) need hospital admission for oxygen supplementation. A substantial number of patients need intensive care unit (ICU) admission for escalation of care. ICU doctors and nurses are struggling to provide the best care for patients with COVID-19. Practice of adjunctive and supportive treatments remains uncertain.
Objective To determine and compare practice of adjunctive and supportive treatments for COVID-19 in the Netherlands, and to determine their independent associations with outcome.
Hypotheses Practice of adjunctive and supportive treatments for COVID-19 varies substantially. Adjunctive and supportive treatments have an independent association with outcome in ICU patients with COVID-19.
Study design National/international, multicenter, retrospective observational study. Study population Intensive care unit (ICU) patients with COVID-19.
Methods In this study we will collect data on diverse treatments during the first 28 days in ICU, including (a) the types of oxygen support* and awake prone positioning; (b) the types of ventilatory support, (c) rescue therapies for refractory hypoxemia during invasive ventilation (prone positioning, ventilator adjustments, continuous muscle paralysis, and extracorporeal membrane oxygenation); (d) adjunctive treatments, including thromboprophylaxis and anticoagulation, antiviral and immunomodulating therapies, and (e) experimental supportive treatments. Outcomes include duration of each adjunctive treatment, duration of ventilation, incidence of tracheostomy, duration of stay in ICU and mortality until day 90.
Study endpoints A combination of adjunctive treatments, including types of oxygen support, ventilatory support and rescue therapies for refractory hypoxemia during invasive ventilation (primary), other adjunctive and supportive treatments, tracheostomy rate; duration of ventilation and ventilator-free days and alive at day 28 (VFD-28), duration of ICU and hospital stay, and ICU, hospital and 90-day mortality.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness Retrospective collection of data regarding adjunctive treatments, and clinical endpoints is without risk for ICU patients.
*In a subset of patients we will collect granular data (every two hours) regarding oxygenation (FiO2, inspiratory tidal volume, air flow, respiratory rate, SpO2, PaO2, and PEEP) over the first 2 full calendar days of ICU admission. The primary endpoint of this sub-analysis will be the amount of oxygen used with different respiratory support interventions. The statistical analysis plan for the analysis of these data that were collected in two ICUs that participated in the national study, and one additional ICU in Spain is uploaded in the document section (filename Statistical Analysis Plan PROXY-COVID)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe coronavirus disease 2019 (COVID-19) admitted to intensive care units (ICUs) in the Netherlands between September 2020 and January 2021 (i.e. during the second surge of COVID-19 patients).
Key inclusion criteria (2 listed)
- COVID-19, confirmed with PCR; and
- Admission to one of the participating ICUs, or an emergency location that serves as an ICU during the pandemic.
Key exclusion criteria (1 listed)
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjunctive therapiesDetermine and compare practice of adjunctive and supportive treatments for COVID-19 | Other | – |
Primary outcome
Mortality
Time frame: 90 days
ICU, hospital and 90-day mortality
Time frame: 90 days
Ventilator-free days and alive at day 28
Time frame: 28 days
ICU length of stay
Time frame: 90 days
Hospital length of stay
Time frame: 90 days
6 secondary outcomes
Proven deep vein thrombosis (DVT)
Time frame: 28 days
Incidence of gastrointestinal bleeding
Time frame: 28 days
Development of acute kidney injury (AKI)
Time frame: 28 days
Incidence of tracheostomy
Time frame: 28 days
Use of renal replacement therapy (RRT)
Time frame: 28 days
Proven pulmonary embolism (PE)
Time frame: 28 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 Jan 2023.
- Derived from this study: PubMed 37452196van der Ven FLIM, Valk CMA, Blok S, Brouwer MG, Go DM, Lokhorst A, Swart P, van Meenen DMP, Paulus F, Schultz MJ; PRoAcT-COVID study investigators. Broadening the Berlin definition of ARDS to patients receiving high-flow nasal oxygen: an observational study in patients with acute hypoxemic respiratory failure due to COVID-19. Ann Intensive Care. 2023 Jul 14;13(1):64. doi: 10.1186/s13613-023-01161-6.
- Derived from this study: PubMed 34268426Valk CMA, Swart P, Boers LS, Botta M, Bos LDJ, de Abreu MG, Hol L, Hollmann MW, Horn J, Martin-Loeches I, Mazzinari G, Myatra SN, Nijbroek SG, Rosenberg NM, Stilma W, Tsonas AM, van der Ven WH, Neto AS, Schultz MJ, Paulus F. Practice of adjunctive treatments in critically ill COVID-19 patients-rational for the multicenter observational PRoAcT-COVID study in The Netherlands. Ann Transl Med. 2021 May;9(9):813. doi: 10.21037/atm-21-764.
- 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.
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 Covid19 and Pneumonia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites 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 10 Jan 2023. 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 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?
Mortality (time frame: 90 days). The study lists 5 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 NCT04719182, which also lists 2 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 10 Jan 2023.