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NCT05012267: OmeLEtte

Duration of Prone Position in the Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19).

Completed NA Last updated 28 October 2021
What this trial tests

NA trial testing 16-hour PP in Ards in 61 participants. Completed in 27 October 2021.

Timeline
25 March 2021
Primary endpoint
27 October 2021
27 October 2021

Quick facts

Lead sponsorIgnacio Saez de la Fuente
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment61
Start date25 March 2021
Primary completion27 October 2021
Estimated completion27 October 2021
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Ignacio Saez de la Fuente

Who can join

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

Sponsor's own description

The OMELETTE study is a randomised, controlled, unicentric, open-label study to prove the noninferiority of reduced prone position (PP) sessions (more tan 16 hours) versus prolonged PP (48 hours).

Publications & conference data

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

  1. ESICM LIVES 2022: part 1.
    · 2022 · cited 4× · PMID 36258101 · DOI 10.1186/s40635-022-00468-1
  2. Optimal Prone Position Duration in Patients With ARDS Due to COVID-19: The Omelette Pilot Trial.
    Sáez de la Fuente I, Marcos Morales A, Muñoz Calahorro R, Álvaro Valiente E, et al · · 2024 · cited 3× · PMID 38531637 · DOI 10.4187/respcare.11192

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Other recruiting trials for Ards

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05012267.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing