Status:
UNKNOWN
Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 Pneumonia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Hypoxemic Respiratory Failure
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age ≥ 18 years
- Admitted to ICU within 48 hours
- Confirmed or highly suspected COVID-19 infection
- 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)
- 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:
- Moribund status
- Pregnancy or breastfeeding
- Long term corticotherapy at a dose of 0.5mg/kg/j or higher
- Active and untreated bacterial, fungal or parasitic infection
- 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
- hypersensitivity to dexamethasone or to any of the excipients
- Not Affiliation to the French social security
Exclusion
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT04344730
Start Date
April 10 2020
End Date
December 31 2021
Last Update
February 9 2021
Active Locations (1)
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1
Hopital Bichat - Aphp
Paris, France, 75018