Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
Dr Amit Patel
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 years or older 2. All suspected COVID-19 hospitalized patient 3. Willing and able to provide written informed consent prior to performing study procedures 4. Has laboratory-non confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay but with typical signs including fever, cough, loss of test, sense of smell and headache etc. 5. Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment (evidence of rales/crackles on exam) AND SpO2 room air, or require mechanical ventilation and/or supplemental oxygen.
Exclusion criteria
Exclusion criteria: 1. Participation in any other clinical trial of an experimental treatment for COVID-19 2. Immunocompromised patients taking medication upon screening 3. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A. Clinical status of subject 1. Hospitalized, not requiring supplemental oxygen; 2. Hospitalized, requiring supplemental oxygen; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, on invasive mechanical ventilation or ECMO; B. Clinical status of subject at discharge 1. Hospitalized, not requiring supplemental oxygen; 2. Hospitalized, requiring supplemental oxygen; 3. Death; Timepoint: During Hospitalization Baseline to till Discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate the safety of treatment in patients with COVID-19Timepoint: At 10 days | — |
Countries
India
Contacts
Public ContactDr Hardik Shah
CIMS Hospital Pvt. Ltd.
Outcome results
None listed