Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: INTRAVENOUS HIGH DOSE DEXAMETHASONE (20MG): Following admission in the COVID ICU, standard treatment according to the COVID management institutional protocol will be done. If there is d
Sponsors
Post Graduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or above of either gender 2. Confirmed SARS-CoV-2 (COVID-19) infection by RT-PCR with PaO2:FIO2 ratio of less than 200 on admission 3. Use of one of the following for hypoxia: a. Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system b. Non-invasive ventilation or HFNC OR c. Invasive mechanical ventilation 4. Within 48 hrs of initiation of standard therapy if a. PaO2:FIO2 ratio worsens by more than 50 from baseline value and b. Oxygenation or ventilation device is upgraded and c. Increasing or static CRP 5. Imaging with chest X-ray/CT-Chest suggestive of COVID 19 related lung opacities. 6. Signature of informed consent by the patient, family member or legal representative
Exclusion criteria
Exclusion criteria: 1. known history of dexamethasone or Tocilizumab allergy 2. Prior history of immunosuppression and use of immunosuppressive drugs 3. Use of corticosteroids for indications other than COVID-19 4. Invasive fungal infection 5. Active tuberculosis 6. Liver injury or failure (AST/ALT >= 5x Upper limit of normal) 7. Leukocytes 8. Thrombocytes 9. Severe bacterial infection (Procalcitonin > 3ng/ml) 10. Acute or chronic diverticulitis 11. unwilling or unable to participate or complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventilator free days (VFD) Timepoint: 0-28days following admission | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality at day 28 Number of participants with one or more serious adverse reactions WHO progression scale at day 7 and 14 [ Time Frame: day 7 and day 14 ] Days alive without circulatory support at day 28 Variation in SOFA over the first 10 days after randomization Use of prone position Serum C-reactive Protein variation All-cause mortality at day 90 ICU stay Viral shedding Duration of hospitalization Timepoint: Mortality-28 days Number of participants with one or more serious adverse reactions-28 days WHO progression scale-day 7 and day 14 Days alive without circulatory support-Day 28 Variation in SOFA over the first 10 days Use of prone position-10 days Serum C-reactive Protein variation-10 days Serum C-reactive Protein variation-10 days ICU stay- 28 days Viral shedding-28 days Duration of hospitalization - 28 and 90 days after hospital discharge. | — |
Countries
India
Contacts
Public ContactDr Naveen Naik B
Post Graduate Institute Of Medical Education And Research
Outcome results
None listed