COVID Clinical Trial
— UPSATOfficial title:
UPright Incline Positioning in COVID-19 Patients for Oxygen SATuration Improvement With Hypoxemic Respiratory Failure (UPSAT)
NCT number | NCT04344561 |
Other study ID # | IRB00246834 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 25, 2020 |
Est. completion date | May 1, 2022 |
Verified date | June 2022 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | May 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - COVID-19 positive - Pneumonia defined as hospitalization for acute (< 7 days) onset of symptoms (cough, sputum production, or dyspnea). - Hypoxemia defined as = 2 L/min oxygen Exclusion Criteria: - Intubation - Inability to lie supine |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Bayview Hospital | Baltimore | Maryland |
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acute change in oxyhemoglobin saturation | Mean oxyhemoglobin saturation (percentage) during final 7 minutes in a position. | During the final 7 minutes at each position, up to 72 hours | |
Primary | Incidence of Mechanical Ventilation | Number of participants needing mechanical ventilation over total number of participants per arm. | 72 hours | |
Secondary | Number of participants with supplemental oxygen requirements | Number of participants with supplemental oxygen requirements. | 72 hours | |
Secondary | Mean oxyhemoglobin saturation | Mean oxyhemoglobin saturation (percentage) measured over a 24-hour period. | At 24, 48 and 72 hours | |
Secondary | Mean Nocturnal Oxyhemoglobin Saturation | Mean oxyhemoglobin saturation (percentage) measured over an 8-hour period (between 10pm and 6am). | Measured between 10pm and 6am daily, up to 72 hours | |
Secondary | Heart Rate | Heart Rate (beats per minute) on Routine Vital Sign Assessment. | At 10, 24, 48 and 72 hours | |
Secondary | Respiratory Rate | Respiratory Rate (cycles per minute) on Routine Vital Sign Assessment. | At 10, 24, 48 and 72 hours | |
Secondary | Percentage of time in the assigned position | Percentage of time participants stay in the assigned position will be used to determine adherence. | 72 hours |
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