Early CPAP in COVID-19 Patients With Respiratory Failure. (EC-COVID-RCT)
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|ClinicalTrials.gov Identifier: NCT04326075|
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|CPAP Ventilation COVID-19 Emergency Departments||Device: CPAP treatment||Not Applicable|
Eligible patients will be randomized to two treatment arms: current clinical practice (control arm) and early treatment with CPAP in addition to current clinical practice (experimental arm). To deal with the current emergency situation, the study will adopt an adaptive design with a Bayesian continuous monitoring. Such design allows to stop the study as soon as the data provide sufficient evidence of efficacy or ineffectiveness of the studied treatment.
The primary endpoint of the study is the combination of intubation or death within 7 days of randomization. The secondary endpoint is 30-day mortality.
All patients arriving at the ED will be evaluated to verify the presence of inclusion and exclusion criteria. Randomization will be performed through an ad-hoc electronic case report form (eCRF). Eligible patients should be randomized as soon as possible, possibly immediately after the ED triage.
Patients randomized to the control arm will be treated according to current clinical practice, which currently does not involve the use of CPAP. Therefore, these patients should not start treatment with CPAP immediately after randomization. CPAP treatment, however, is allowed at a later stage, if deemed appropriate according to clinical judgment.
Patients randomized to the experimental arm should begin treatment with CPAP as soon as possible. CPAP should only be performed with a helmet, using a positive end-expiratory pressure (PEEP) between 8 and 14 cmH2O and an inspired oxygen fraction (FiO2) between 40 and 60%. FiO2 and PEEP must be modulated, within the limits indicated above, so as to obtain a saturation > 94%. Whenever this goal cannot be achieved, the patient should be referred to the intensivist.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||EC-COVID-RCT. Early CPAP in COVID Patients With Respiratory Failure. A Randomized Clinical Trial|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: Early CPAP treatment
Early treatment with CPAP in addition to current clinical practice
Device: CPAP treatment
CPAP should be performed as soon as possible and only with a helmet, using a positive end-expiratory pressure (PEEP) between 8 and 14 cmH2O and an inspired oxygen fraction (FiO2) between 40 and 60%.
No Intervention: Control
Current clinical practice, which currently does not involve the use of CPAP.
- Death or need of intubation [ Time Frame: 7 days since ED arrival ]The study outcomes will be death or need of intubation within 7 days since ED arrival.
- 30-day mortality [ Time Frame: 30 days since ED arrival ]30-day mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326075
|Contact: Guido Bertolini, MD||+39 035 4554 firstname.lastname@example.org|
|Contact: Elena Garbero, M.Sc.||+39 035 4554 email@example.com|
|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico||Recruiting|
|Milan, Italy, 20122|
|Contact: Giorgio Costantino 02 99.95.99 firstname.lastname@example.org|
|Principal Investigator:||Guido Bertolini, MD||Istituto di Ricerche Farmacologiche Mario Negri IRCCS|