There is one clinical trial.
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.
Description: Number of participants needing mechanical ventilation over total number of participants per arm.Measure: Incidence of Mechanical Ventilation Time: 72 hours
Description: Number of participants with supplemental oxygen requirements.Measure: Number of participants with supplemental oxygen requirements Time: 72 hours
Description: Mean oxyhemoglobin saturation (percentage) measured over a 24-hour period.Measure: Mean oxyhemoglobin saturation Time: At 24, 48 and 72 hours
Description: Mean oxyhemoglobin saturation (percentage) measured over an 8-hour period (between 10pm and 6am).Measure: Mean Nocturnal Oxyhemoglobin Saturation Time: Measured between 10pm and 6am daily, up to 72 hours
Description: Heart Rate (beats per minute) on Routine Vital Sign Assessment.Measure: Heart Rate Time: At 10, 24, 48 and 72 hours
Description: Respiratory Rate (cycles per minute) on Routine Vital Sign Assessment.Measure: Respiratory Rate Time: At 10, 24, 48 and 72 hours
Description: Percentage of time participants stay in the assigned position will be used to determine adherence.Measure: Percentage of time in the assigned position Time: 72 hours
Description: Mean oxyhemoglobin saturation (percentage) during final 7 minutes in a position.Measure: Acute change in oxyhemoglobin saturation Time: During the final 7 minutes at each position, up to 72 hours
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports