Dexamethasone Treatment for Severe Acute Respiratory Distress Syndrome Induced by COVID-19

• Status: Terminated
• Trial end date: 2020-08-07
• Target enrollment: 0
• Participant gender: All

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) related to coronavirus disease 19 (COVID-19). We hypothesize that dexamethasone (20 mg for 5 days followed by 10 mg for 5 days) combined with 600 mg per day dose of hydroxychloroquine for 10 days will reduce the 28-day mortality compared to hydroxychloroquine alone in patients with severe ARDS related COVID-19.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Chirurgical Marie Lannelongue
• Treatments: Dexamethasone; Hydroxychloroquine

Criteria

Inclusion Criteria:

1. Patient over 18 years old

2. Patient affiliated to a health insurance plan

3. 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

4. Kaliemia > 3,5 mmol / L

5. 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 Criteria:

1. Patient under guardianship or curator

2. Patient with plausible alternate diagnosis

3. ARDS evolving for more than 4 days

4. 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

5. 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

6. Uncontrolled septic shock

7. Untreated active infection or treated less than 24 hours

8. Long-term patient treated with corticosteroids (> 20 mg / day) or Hydroxychloroquine

9. Immunocompromised patients: AIDS, bone marrow or solid organ transplant recipients

10. Pregnant women

11. Glucose-6-phosphate dehydrogenase (G6PD) deficiency