Early CPAP in COVID-19 Patients With Respiratory Failure.

COVID-19 Clinical Trial

— EC-COVID-RCT  

Official title:

EC-COVID-RCT. Early CPAP in COVID Patients With Respiratory Failure. A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326075
• Other study ID #: EC-COVID-RCT-Fenice
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: December 2021
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims at clarifying whether early treatment with continuous positive airway pressure (CPAP) ventilation is able to reduce the need for intubation or death in patients visiting an emergency department (ED) with known or suspected COVID-19 infection and insufficiency respiratory.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 15, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

ED patients positive to or suspected of COVID-19 infection with at least one of the following symptoms:

• fever

• cough/dyspnea

• respiratory symptoms or ED arrival for respiratory reason and for whom there are the following conditions:

• SpO2 < 95% in ambient air or positive Quick Walk Test

• PaO2/FiO2 > 200 in ambient air or with Venturi mask, evaluated in 1 hour from ED arrival.

Exclusion Criteria:

• BPCO patients

• Age > 70 years

• Pregnant status

• Contraindications for CPAP

Related Conditions & MeSH terms

• COVID-19
• CPAP Ventilation
• Emergencies
• Emergency Departments
• Respiratory Insufficiency

Intervention

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%.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or need of intubation	The study outcomes will be death or need of intubation within 7 days since ED arrival.	7 days since ED arrival
Secondary	30-day mortality	30-day mortality	30 days since ED arrival