|drug2112||Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR Wiki||1.00|
There is one clinical trial.
There is surge in COVID infected patients in New York City with a shortage of hospital beds, ICU beds and ventilators. Strategies to reduce the need for all of the above are immediately needed. Further, few interventions are targeted in COVID infected patients early in the course of their disease and especially in the community/home settings. Respiratory decompensation appears to occur later in the disease process (i.e. 7-10 days after becoming symptomatic) therefore many patients are sent home from the Emergency Room and they subsequently decompensate later at home. Some patients die at home and others are returning to the Emergency Room with hypoxemic respiratory failure. There is no treatment offered to this population of patients, i.e. COVID suspected or confirmed and with respiratory symptoms or abnormal chest x-ray at the time of presentation. Based on experience across the globe, these patients are likely to worsen at home. The study team therefore proposes a prospective, single-center, parallel group, open-label, randomized clinical trial to assess the efficacy of fixed low continuous positive airway pressure therapy (CPAP) (FDA approved and often used for treatment of sleep apnea) in COVID confirmed or suspected patients with abnormal chest x-ray or respiratory symptoms who do not require hospital admission and are discharged home from the emergency room.
Description: Non-weighted composite score comprised of the following components: All-cause mortality within 14 days of randomization, hospital Admission (including ED visit) within 14 days of randomization, oxygen saturation less than 90 during the 72-hour observation period from randomization, absolute reduction in oxygen saturation of more than 4% during the 72-hour observation period from randomization.Measure: Efficacy Endpoint composite score Time: 14 days
Description: The time from randomization to an admission to the intensive care unit within 14 days from randomizationMeasure: Time to ICU admission Time: 14 days from randomization
Description: The time from randomization to the patient needing to be intubated and needing mechanical ventilation within 14 days from randomizationMeasure: Time to Intubation and mechanical ventilation Time: 14 days from randomization
Description: The time from randomization to death within 14 and 28 days from randomizationMeasure: 14 day and 28 day mortality Time: 14-28 days from randomization
Description: The conversation rate of household members from being COVID negative to COVID positive in the CPAP arm vs the control arm within 14 days from randomizationMeasure: Conversion rate of COVID household members in CPAP vs control Time: 14 days from randomization
Description: If there is any improvement in respiratory symptoms of cough or shortness of breath etc. assessed via a respiratory symptom questionnaire within 14 days from randomization. The CCQ is a 10-item instrument, full scale from 0 to 6, with higher score indicating lower health status.Measure: Clinical COPD Questionnaire (CCQ) Time: 14 days from randomization
Description: Percentage of the patients in the CPAP arm elect to continue using the CPAP after the initial 72 hour period.Measure: Percentage of patients electing to continue CPAP for greater than 72 hours Time: 7 days from randomization
Description: The degree of improvement in oxygen saturation within 14 days of randomization.Measure: Degree of improvement in oxygen saturation Time: 14 days from randomization
Description: Time to hospital admission or ED within 14 days of randomizationMeasure: Time to hospital admission or ED Time: 14 days from randomization
Data processed on December 13, 2020.