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NCT04344561 · ClinicalTrials.gov registry record · NA

Incline Positioning in COVID-19 Patients for Improvement in Oxygen Saturation

A NA study, sponsored by Johns Hopkins University.

Terminated
Registry status
NA
Development phase
7
Enrollment target

NCT04344561: Clinical Trial NA study, sponsored by Johns Hopkins University.

NCT04344561 is a NA study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04344561, a NA study, was terminated before completion, sponsored by Johns Hopkins University.

TERMINATED
Registry status
NA
Development phase
7 participants
Enrollment target

Study Summary

COVID-19 is a respiratory illness caused by SARS-CoV-2 with a range of symptoms from mild, self-limiting respiratory tract infections to severe progressive pneumonia, multiorgan dysfunction and death. A portion of individuals with COVID-19 experience life-threatening hypoxia requiring supplemental oxygen and mechanical ventilation. Management of hypoxia in this population is complicated by contraindication of non-invasive ventilation and limitations in access to mechanical ventilation and critical care staff given the clinical burden of disease. Positional therapy is readily deployable and may ultimately be used to treat COVID-19 related respiratory failure in resources limited settings; and, it has been demonstrated to improve oxygenation and is easy to implement in the clinical setting. The overall goal of this randomized controlled trial is to establish the feasibility of performing a randomized trial using a simple, minimally invasive positional therapy approach to improve hypoxia and reduce progression to mechanical ventilation. The objectives are to examine the effectiveness and feasibility of maintaining an inclined position in patients with confirmed or suspected COVID-19 associated hypoxemic respiratory failure. The investigators hypothesize that (1) oxyhemoglobin saturation will improve with therapy, (2) participants will tolerate and adhere to the intervention, and that (3) participants who adhere to positional therapy will have reduced rates of mechanical ventilation at 72 hours. If successful, this feasibility trial will demonstrate that a simple, readily deployed nocturnal postural maneuver is well tolerated and reverses underlying defects in ventilation and oxygenation due to COVID-19. It will also inform the design of a pivotal Phase III trial with estimates of sample sizes for clinically relevant outcomes.

Interventions

  • OTHER Postural Positioning

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2020-05-25
Est. Completion 2022-05-01
Phase NA

Sponsor

Johns Hopkins University

1,448 total trials

What the Registry Record Tells You About NCT04344561

The ClinicalTrials.gov registry entry for NCT04344561 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Postural Positioning is the first listed.

NCT04344561 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04344561 about?

NCT04344561 is a clinical study titled "Incline Positioning in COVID-19 Patients for Improvement in Oxygen Saturation". COVID-19 is a respiratory illness caused by SARS-CoV-2 with a range of symptoms from mild, self-limiting respiratory tract infections to severe progressive pneumonia, multiorgan dysfunction and death. A portion of individuals with COVID-19 experience life-threatening hypoxia requiring supplemental o...

What is the current status of trial NCT04344561?

This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2020-05-25. Estimated completion is 2022-05-01.

What interventions are being tested in trial NCT04344561?

The interventions under investigation include: Postural Positioning (OTHER).

Who is sponsoring clinical trial NCT04344561?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.