Overview

Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 Pneumonia

Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
Summary
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival. The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
BB 1101
Dexamethasone
Dexamethasone acetate
Criteria
Inclusion Criteria:

1. Age ≥ 18 years

2. Admitted to ICU within 48 hours

3. Confirmed or highly suspected COVID-19 infection

4. Acute hypoxemic respiratory failure (PaO2 <70 mmHg or SpO2<90% on room air or
tachypnea>30/min or labored breathing or respiratory distress; need for oxygen flow
>=6L/min)

5. Any treatment intended to treat the SARS-CoV-2 infection in the absence of
contraindications (either as a compassionate use or in the context of a clinical
trial, i.e remdesivir, lopinavir/ritonavir, favipiravir, hydroxychloroquine and any
other new drug with potential activity).

Non-inclusion Criteria:

1. Moribund status

2. Pregnancy or breastfeeding

3. Long term corticotherapy at a dose of 0.5mg/kg/j or higher

4. Active and untreated bacterial, fungal or parasitic infection

5. Not Written informed consent from the patient or a legal representative if appropriate
. If absence a legal representative the patient may be included in emergency procedure

6. hypersensitivity to dexamethasone or to any of the excipients

7. Not Affiliation to the French social security