Early CPAP in COVID-19 Patients With Respiratory Failure.

NCT ID: NCT04326075

Last Updated: 2022-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-12-15

Brief 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.

Detailed 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.

Conditions

CPAP Ventilation; COVID-19; Emergency Departments

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early CPAP treatment

Early treatment with CPAP in addition to current clinical practice

Group Type: EXPERIMENTAL

CPAP treatment

Intervention Type: DEVICE

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%.

Control

Current clinical practice, which currently does not involve the use of CPAP.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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%.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guido Bertolini, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Di Ricerche Farmacologiche Mario Negri

Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Countries

Italy

Other Identifiers

EC-COVID-RCT-Fenice

Identifier Type: -

Identifier Source: org_study_id