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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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants needing mechanical ventilation over total number of participants per arm.
Interventions
- OTHER Postural Positioning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-05-25 |
| Est. Completion | 2022-05-01 |
| Phase | NA |
Why NCT04344561 stopped before completion
NCT04344561 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Postural Positioning is the first listed.
NCT04344561 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04344561's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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