Early CPAP in COVID-19 Confirmed or Suspected Patients
Atslēgvārdi
Abstrakts
Apraksts
The study team proposes a randomized controlled trial of CPAP (n=100) vs. control (n=100) in COVID-19 suspected or confirmed patients with pneumonia or respiratory illness. The overarching aim of this proposal is to determine if early use of CPAP at home will reduce hypoxemic events or reduce the need for hospital admission or death in COVID-19 suspected or confirmed patients. The study team will include adult patients (age>18) who live alone or have more than one bedroom at home, with serologically confirmed or suspected COVID-19 infection, who have one or more of the following: fever (>38ºC), sore throat, myalgia or flu-like illness AND have one or more of the following additional symptom or diagnostic criteria: abnormal chest x-ray, new onset cough, mild hypoxemia at rest (saturation less than 96%), abnormal lung exam, chest tightness or shortness of breath AND who are without need for hospital admission. Patients with preexisting pulmonary diseases such as advanced COPD, advanced parenchymal lung disease, history of pneumothorax etc. will be excluded. Participants in both arms will be shipped a pulse oximeter to monitor oxygen saturation and a disposable home sleep apnea monitor (WatchPAT) to track blood oxygen level continuously for 12 hours with data feed into a cloud based platform. Additionally, 100 patients will be randomized to receive CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc). The CPAP pressure will be adjusted based on patient's comfort but will not deviate from the range of 8-10cm. While the study protocol will end at 72 hours, patients who wish to continue CPAP will be allowed to do so for symptomatic benefit up to 7 days from randomization. All CPAP recipients will be given a full-face mask and will be asked to stay in quarantine for the duration of the protocol to avoid risk of infecting family members with aerosol (separate consent to be obtained from household members who are elderly or with comorbidities.) The study team hypothesizes that early low-grade fixed CPAP in COVID infected patients who have respiratory abnormalities will reduce hypoxemic events and decrease the risk of subsequent hospitalization or death in 14 days from randomization. The study will also address whether use of CPAP in the home increases the risk of infecting household family members.
Datumi
| Pēdējoreiz pārbaudīts: | 04/30/2020 |
| Pirmais iesniegtais: | 05/11/2020 |
| Paredzētā reģistrācija iesniegta: | 05/12/2020 |
| Pirmais izlikts: | 05/14/2020 |
| Pēdējais atjauninājums iesniegts: | 05/12/2020 |
| Pēdējā atjaunināšana ievietota: | 05/14/2020 |
| Faktiskais studiju sākuma datums: | 05/06/2020 |
| Paredzamais primārās pabeigšanas datums: | 03/31/2021 |
| Paredzamais pētījuma pabeigšanas datums: | 04/30/2021 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Device: Continuous Positive Airway Pressure (CPAP)
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Experimental: Continuous Positive Airway Pressure (CPAP) Patients will be given CPAP at fixed pressure of 8-10 cm water pressure for 72 hours continuously | Device: Continuous Positive Airway Pressure (CPAP) CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc). |
| No Intervention: Control Patients in this arm will be not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days. |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | All |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | Inclusion criteria: 1. Adults > 18 years old 2. Patients living alone or with more than one room at home 3. COVID confirmed or suspected 4. To be discharged home or already discharged 5. One or more of these: fever (>38oC), sore throat, myalgia or flu-like illness 6. 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 Exclusion criteria: 1. Unable to self quarantine for 72 hours if in the CPAP arm 2. Preexisting pulmonary diseases such as advanced COPD, advanced parenchymal lung disease, history of pneumothorax etc. 3. Claustrophobic and unable to tolerate CPAP mask 4. Evidence of hypercapnia 5. Recent heart of lung surgery within 3 months 6. Individuals without access to smart phones or wireless connection or internet access 7. Prior history of aspiration 8. Speech or swallowing impairment (risk of aspiration) 9. History of stroke with significant neurologic deficit 10. Advanced symptomatic heart failure 11. Unable to provide informed consent 12. household with young children and child care responsibilities 13. household with high-risk individuals (defined as over 60 or with comorbidities (e.g. heart disease, diabetes, pulmonary)) |
Rezultāts
Primārie rezultāti
1. Efficacy Endpoint composite score [14 days]
Sekundārie iznākuma mērījumi
1. Time to ICU admission [14 days from randomization]
2. Time to Intubation and mechanical ventilation [14 days from randomization]
3. 14 day and 28 day mortality [14-28 days from randomization]
4. Conversion rate of COVID household members in CPAP vs control [14 days from randomization]
5. Clinical COPD Questionnaire (CCQ) [14 days from randomization]
6. Percentage of patients electing to continue CPAP for greater than 72 hours [7 days from randomization]
7. Degree of improvement in oxygen saturation [14 days from randomization]
8. Time to hospital admission or ED [14 days from randomization]
