Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Methylprednesolone cohort: Systemic steroids given pre-emptively at Day 5 in addition to the standard care:
Methylprednisolone administered for 14 Days: 2 phases- prevention phase for 1
Sponsors
JK Hospital and LN Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or non-pregnant female adult >=â??18â??years of age at the time of enrolment 2.Confirmed diagnosis of SARS-CoV-2 infection, defined as either: a. SARS-CoV-2 PCR positive within 72â??h before randomization or b. In patients without PCR-confirmed diagnosis at inclusion, all efforts will be made to confirm definite SARS-CoV-2 infection (e.g., PCR on bronchial aspirate, PCR on BAL fluid or serologic testing). Participants whoâ??despite all effortsâ??do not have a confirmed diagnosis of COVID-19 will be excluded from the analysis. 3. Patients eligible for home isolation.
Exclusion criteria
Exclusion criteria: 1. Moderate to Severe type of disease, with at least one of the following criteria: o Frequency of breath > 24 per minute, which does not decrease after the body temperature drops to normal or subfebrile values; o Blood oxygen saturation (SpO2) o Chest involvement on HRCT o Partial pressure of oxygen in arterial blood (PaO2) o Oxygenation index (RaO2/FiO2) o Partial pressure of CO2 in arterial blood (PaCO2) o Septic shock. 2. Patients treated with lopinavir/ritonavir, ribavirin, arbidol, chloroquine, hydroxychloroquine, mefloquine, favipiravir within 7 days prior to screening. 3. Severe cardiovascular diseases currently or 6 months prior to trial. uncontrolled arterial hypertension with systolic blood pressure > 180 mm Hg and diastolic blood pressure > 110 mm Hg, pulmonary embolism or deep vein thrombosis. 4. Severe chronic renal impairment (GFR 5. A history of cirrhosis or an increase in alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) > 5 times Ã? upper limit of normal (ULN). 7. Significant uncontrolled concomitant disease, e.g. neurological, renal, hepatic, endocrinological or gastrointestinal disorder which according to the Investigator, could prevent the patient from participating in the study 8. Malignancies that require chemotherapy within 6 months prior to screening. 9. Known HIV infection. 10. Uncontrolled Diabetes Mellitus. 11. Participation in other clinical studies or taking other study drugs within 28 days prior to screening. 12. Pregnant or lactating women. 13. Patients not giving consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients requiring hospitalisation, supplemental oxygen and/or ICU care as compared to Standard of care protocol. Timepoint: Baseline, 7 days, 14 days and if applicable-ICU Status/ hospitalisation time | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost effectivenesss of the proposed protocolTimepoint: RT-PCR negative patients(2weeks and 4 weeks followup) | — |
Countries
India
Contacts
Public ContactPrakhar Gupta
JK Hospital and LN Medical College
Outcome results
None listed