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NCT04381923: COVIDNOCHE

COVIDNOCHE Trial (HFNO Versus CPAP Helmet) in COVID-19 Pneumonia

Withdrawn NA Last updated 5 April 2022
What this trial tests

NA trial testing Helmet Continuous Positive Airway Pressure (CPAP) in Severe Acute Respiratory Syndrome Coronavirus 2. Withdrawn.

Timeline
15 November 2021
Primary endpoint
15 November 2022
15 December 2022

Quick facts

Lead sponsorUniversity of Pennsylvania
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposesupportive care
Start date15 November 2021
Primary completion15 November 2022
Estimated completion15 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with Severe Acute Respiratory Syndrome Coronavirus 2 or Hypoxemic Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the COVIDNOCHE trial (HFNO versus CPAP Helmet Evaluation in COVID-19 Pneumonia) is to evaluate the comparative effectiveness of standard care non-invasive respiratory support (helmet CPAP versus HFNO) for acute hypoxemic respiratory failure from COVID-19 pneumonia on ventilator-free days (primary outcome) and other clinical outcomes measured up to 90 days.

Publications & conference data

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

  1. Clinical Management of Adult Patients with COVID-19 Outside Intensive Care Units: Guidelines from the Italian Society of Anti-Infective Therapy (SITA) and the Italian Society of Pulmonology (SIP).
    Bassetti M, Giacobbe DR, Bruzzi P, Barisione E, et al · · 2021 · cited 29× · PMID 34328629 · DOI 10.1007/s40121-021-00487-7
  2. COVID-19 Critical Illness: A Data-Driven Review.
    Ginestra JC, Mitchell OJL, Anesi GL, Christie JD. · · 2022 · cited 24× · PMID 34520220 · DOI 10.1146/annurev-med-042420-110629
  3. Early Clinical Experience in Using Helmet Continuous Positive Airway Pressure and High-Flow Nasal Cannula in Overweight and Obese Patients With Acute Hypoxemic Respiratory Failure From Coronavirus Disease 2019.
    Gaulton TG, Bellani G, Foti G, Frazer MJ, et al · · 2020 · cited 16× · PMID 32984836 · DOI 10.1097/cce.0000000000000216
  4. High-Flow Nasal Oxygen and Noninvasive Ventilation for COVID-19.
    Al-Dorzi HM, Kress J, Arabi YM. · · 2022 · cited 4× · PMID 35667746 · DOI 10.1016/j.ccc.2022.01.006
  5. Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial.
    Arabi YM, Tlayjeh H, Aldekhyl S, Al-Dorzi HM, et al · · 2021 · cited 4× · PMID 34446500 · DOI 10.1136/bmjopen-2021-052169
  6. Noninvasive ventilation strategies for patients with severe or critical COVID-19: A rapid review of clinical outcomes
    Kelly SE, Wells GA. · · 2022 · DOI 10.1101/2022.05.25.22275586
  7. Helmet noninvasive ventilation for COVID-19 patients “Helmet-COVID”: study protocol for a multicenter randomized controlled trial
    Arabi Y, Tlayjeh H, Aldekhyl S, Al-Dorzi HM, et al · · 2021 · DOI 10.1101/2021.08.04.21260420

Verify or expand the search:

Other recruiting trials for Severe Acute Respiratory Syndrome Coronavirus 2

Currently open trials in the same condition.

Other University of Pennsylvania trials

Trials by the same sponsor.

Verify against primary sources

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/NCT04381923.

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