Status:
TERMINATED
Dexamethasone Treatment for Severe Acute Respiratory Distress Syndrome Induced by COVID-19
Lead Sponsor:
Centre Chirurgical Marie Lannelongue
Conditions:
Respiratory Distress Syndrome, Adult
COVID-19
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Single blind randomized clinical trial designed to evaluate the efficacy of the combination of hydroxychloroquine and dexamethasone as treatment for severe Acute Respiratory Distress Syndrome (ARDS) r...
Detailed Description
The severe acute respiratory syndrome coronavirus 2 pandemic causing COVID-19 disease affects hundreds of thousands of patients. Of these, 5% will present with acute respiratory failure, the most seve...
Eligibility Criteria
Inclusion
- Patient over 18 years old
- Patient affiliated to a health insurance plan
- Patient who has given their free, informed and written consent or patient for whom an independent doctor has given their signed consent as part of an emergency procedure
- Kaliemia \> 3,5 mmol / L
- Patient diagnosed COVID-19 positive by reverse transcription-polymerase chain reaction (RT-PCR) and / or CT
- The diagnosis of COVID-19 will be made if:
- Patient with radiological images strongly suggestive of a chest scan associated with respiratory symptoms, without other obvious etiologies OR
- Patient with suggestive respiratory symptoms associated with a positive RT-PCR
- Patients admitted to intensive care with acute respiratory distress syndrome secondary to COVID-19, intubated for less than 5 days with:
- Either - Hypoxemia defined by a arterial partial pressure of oxygen / fraction of inspiratory oxygen ratio (PaO2 / FiO2) ratio \<100 after 2 sessions of prone position
- Either - An alteration in pulmonary compliance (tidal volume divided by plateau pressure minus positive expiratory pressure) immediately or over the first 96 hours after the start of ARDS defined by:
- immediately: impossibility of maintaining a plateau pressure \<30 cm of water in a ventilated patient with a tidal volume of 6 ml / kg of weight predicted by the size and a positive expiratory pressure at 10 cm of water
- during the course of the evolution: decrease in compliance by 20% compared to the initial compliance (day of treatment of the intubated and ventilated patient) We define the start date of ARDS by the day and time when the patient is intubated and ventilated with regard to our definition of COVID-19
Exclusion
- Patient under guardianship or curator
- Patient with plausible alternate diagnosis
- ARDS evolving for more than 4 days
- Contraindication to the Hydroxychloroquine : Known allergy or intolerance to the Hydroxychloroquine or to one of the excipients of the drug, in particular to lactose; documented QT prolongation and / or known risk factors for QT prolongation (including ongoing treatment with citalopram, escitalopram, hydroxyzine, domperidone or piperaquine), retinopathies
- Contraindication to Dexamethasone: Known allergy or intolerance to Dexamethasone or to one of the excipients of the drug, another evolving virosis (hepatitis, herpes, chickenpox, shingles), severe coagulation disorder
- Uncontrolled septic shock
- Untreated active infection or treated less than 24 hours
- Long-term patient treated with corticosteroids (\> 20 mg / day) or Hydroxychloroquine
- Immunocompromised patients: AIDS, bone marrow or solid organ transplant recipients
- Pregnant women
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04347980
Start Date
April 17 2020
End Date
August 7 2020
Last Update
August 12 2021
Active Locations (1)
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1
Reanimation adulte. Hopital Marie Lannelongue
Le Plessis-Robinson, France, 92350