Early CPAP in COVID-19 Patients With Respiratory Failure.

NCT04326075 | Completed DMC

• 1 other identifier: EC-COVID-RCT-Fenice
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

CPAP Ventilation; COVID-19; Emergency Departments

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 30-day mortality

  30 days since ED arrival

Study Arms (2)

Early CPAP treatment

EXPERIMENTAL

Early treatment with CPAP in addition to current clinical practice

Device: CPAP treatment

Control

NO INTERVENTION

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

Interventions

CPAP treatment 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%.

Early CPAP treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• BPCO patients
• Age \> 70 years
• Pregnant status
• Contraindications for CPAP

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

MeSH Terms

Conditions

COVID-19; Emergencies

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Guido Bertolini, MD

  Istituto Di Ricerche Farmacologiche Mario Negri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: December 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 15, 2022
• Last Updated: December 19, 2022

Record last verified: 2021-12

Locations

IT (1)