COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04390191

Neomi Shah, MD, MPH, MS

neomi.shah@mssm.edu

2020-05-15

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: adults > 18 years old patients living alone or with more than one room at home covid confirmed or suspected to be discharged home or already discharged one or more of these: fever (>38oc), sore throat, myalgia or flu-like illness one or more of the following: abnormal chest x-ray, new onset cough, mild hypoxemia (saturation between 92-96%), abnormal lung exam, chest tightness or shortness of breath

unable to self quarantine for 72 hours if in the cpap arm preexisting pulmonary diseases such as advanced copd, advanced parenchymal lung disease, history of pneumothorax etc. claustrophobic and unable to tolerate cpap mask evidence of hypercapnia recent heart of lung surgery within 3 months individuals without access to smart phones or wireless connection or internet access prior history of aspiration speech or swallowing impairment (risk of aspiration) history of stroke with significant neurologic deficit advanced symptomatic heart failure unable to provide informed consent household with young children and child care responsibilities household with high-risk individuals (defined as over 60 or with comorbidities (e.g. heart disease, diabetes, pulmonary))

2

Icahn School of Medicine at Mount Sinai

18

None

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

4

Number of Participants Who Met the Efficacy Endpoint

None

Not reported

[{"arm_notes": "", "treatment_id": 320, "treatment_name": "Continuous positive airway pressure", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]