Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Either male or female of age range 18-65 years 2. Patients with mild to moderate COVID-19 infection and RT-PCR confirmed diagnosis of COVID-19. 3. Subjects willing to give written informed consent and come for a regular follow up. 4. Subjects willing to abide by and comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients presenting severe multisystemic symptoms compatible with advanced Covid-19 and intercurrent acute or severe chronic diseases (i.e. active cancer). 2. Presence of acute hypoxic respiratory failure 3. Requires Intensive care unit (ICU) care for management of ongoing clinical status 4. Severe infection, defined as need for invasive or non-invasive ventilator support 5. Inability to intake or tolerate oral medication 6. Category 6 or 5 based on modified 7-category ordinal scale of clinical status 7. Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission 8. Pregnant or lactating subjects 9. With any secondary complication such as diabetes, cancer, HIV or hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in clinical cure based on clinicianâ??s global assessment of symptomsTimepoint: Day 1, Day 7, Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in C-Reactive Protein & IL-6Timepoint: Baseline and Day 28;Changes in chest X-ray and ECG testsTimepoint: Baseline and Day 28;Changes in Hematology, Biochemistry and urine analysis valuesTimepoint: Baseline and Day 28;Changes in RT-PCR test results from baselineTimepoint: Day 1 and Day 28;Disappearance of symptoms in timeTimepoint: Day 1 to Day 28;Improvement in Oxygen saturation levelsTimepoint: Day 1, Day 7, Day 14 and Day 28;Necessity of invasive assisted ventilation, Necessity of non-invasive assisted ventilation, Intensive care unit admissionTimepoint: Day 1 to Day 28;Post-anesthesia care unit admission, Hospital admission, Medical consultation, Home care and isolation time, Bed rest time etc.Timepoint: Day 1 to Day 28;Subject global assessment of symptomsTimepoint: Day 1 to Day 28;Subjective perception of recoveryTimepoint: Day 28;WHO Covid19 7 point ordinal scale assessmentTimepoint: Day 1, Day 7, Day 14 and Day 28 | — |
Countries
India
Contacts
Pharexcel Consulting