NCT04719182: PRoAcT-COVID

Practice of Adjunctive Treatments in Intensive Care Unit Patients With COVID-19

Completed Last updated 10 January 2023

What this trial tests

trial testing Adjunctive therapies in Covid19 in 1,011 participants. Completed in 1 April 2021.

Timeline

1 September 2020

Primary endpoint
1 April 2021

1 April 2021

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,011
Start date	1 September 2020
Primary completion	1 April 2021
Estimated completion	1 April 2021
Sites	2 locations across Netherlands

Drugs / interventions tested

• Adjunctive therapies

Conditions studied

• Covid19 — all drugs for Covid19 →
• Pneumonia — all drugs for Pneumonia →
• Thrombosis — all drugs for Thrombosis →
• Thromboembolism — all drugs for Thromboembolism →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

18 and older, any sex, with Covid19 or Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   van der Ven FLIM, Valk CMA, Blok S, Brouwer MG, et al · · 2023 · cited 12× · PMID 37452196 · DOI 10.1186/s13613-023-01161-6
2. Oxygen Consumption with High-Flow Nasal Oxygen versus Mechanical Ventilation- An International Multicenter Observational Study in COVID-19 Patients (PROXY-COVID).
   Botta M, Caritg O, van Meenen DMP, Pacheco A, et al · · 2023 · cited 6× · PMID 36972693 · DOI 10.4269/ajtmh.22-0793
3. Practice of adjunctive treatments in critically ill COVID-19 patients-rational for the multicenter observational PRoAcT-COVID study in The Netherlands.
   Valk CMA, Swart P, Boers LS, Botta M, et al · · 2021 · cited 6× · PMID 34268426 · DOI 10.21037/atm-21-764
4. Practice of Awake Prone Positioning in Critically Ill COVID-19 Patients-Insights from the PRoAcT-COVID Study.
   Stilma W, Valk CMA, van Meenen DMP, Morales L, et al · · 2022 · cited 4× · PMID 36498564 · DOI 10.3390/jcm11236988
5. Differences in Ventilation Management and Outcomes between the Two First Waves of the COVID-19 Pandemic-A Comparison between Two Nationwide Observational Studies in The Netherlands.
   Hol L, Schultz MJ, Martin-Loeches I, van Meenen DMP, et al · · 2023 · cited 3× · PMID 37445542 · DOI 10.3390/jcm12134507
6. The PROtective VEntilation (PROVE) Network - advancing research and collaboration in mechanical ventilation.
   Schultz MJ, Ball L, Bernardi M, Battaglini D, et al · · 2025 · PMID 40929471 · DOI 10.62675/2965-2774.20250399
7. Incidence of Air Leaks in Critically Ill Patients with Acute Hypoxemic Respiratory Failure Due to COVID-19.
   Goossen RL, Verboom M, Blacha M, Smesseim I, et al · · 2023 · PMID 36980464 · DOI 10.3390/diagnostics13061156