Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Thalidomide: Drug - Thalidomide
Dose - 100 mg, single tablet
Frequency - Once daily
Route of administration - Oral
Duration of therapy - 7 days
Control Intervention1: N/A: N/A
Sponsors
Dr Abhijit R Lodha
Eligibility
Inclusion criteria
Inclusion criteria: i. Adult patients between the ages of 18-65 diagnosed with swab-positive covid-19 pneumonia (with moderate and moderate to severe disease) ii. Radiographic evidence of pulmonary involvement iii. Requiring any external respiratory assistance (either supplementary oxygen or bipap) iv. PaO2/FiO2 ratio 100 v. Already on standard therapy including dexamethasone and remdesivir in standard doses as prescribed by ICMR vi. Patients with raised inflammatory mediators (including interleukin-6) who are considered candidates for routinely used immunomodulators such as tocilizumab but unable to afford it
Exclusion criteria
Exclusion criteria: i. Pregnant women ii. Women of child-bearing age where pregnancy cannot be unequivocally excluded iii. Patients who have received colony stimulating factors, blood transfusions, or have other systemic conditions that could confound the measured inflammatory markers. iv. Patients with hepatic dysfunction v. Patients requiring invasive ventilatory support, irrespective of their PaO2/FiO2 ratio vi. Pre-existing uncontrolled comorbidities including, but not limited to, COPD, asthma, interstitial lung disease, pulmonary hypertension, cardiac failure, hepatorenal failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Interleukin-6 levelsTimepoint: Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 7-point WHO ordinal scale for clinical improvementTimepoint: At time of discharge or death | — |
Countries
India
Contacts
Public ContactDr Abhijit R Lodha
Ruby Hall Clinic
Outcome results
None listed