Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with RT-PCR confirmed COVID-19 illness. Age of 18-65 years of either sex (Both including) Mild to Moderate Covid 19 disease (NEWS score NMT 7) Signed informed consent. Cases with or without presenting with fever and/or upper respiratory tract illness (Influenza-like illness, ILI). Subjects at high risk of exposure to COVID 19 Health care and frontline workers involved in the treatment of COVID19 cases Family members of COVID19 cases or direct contact
Exclusion criteria
Exclusion criteria: Subjects with any comorbidity which is critical at the screening Allergies, known to be allergic to research drugs Confirmed pneumonia cases with or without symptoms Patients who have participated in other clinical trials within 1 month Proves unfit for the study as a sole discretion of the investigator Being pregnant or breastfeeding Requiring ICU admission at the screening Past History of MI, Epileptic episodes Not giving consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of subjects with negative RT-PCR for COVID 19 at the end of study Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, loss of appetite, fatigue on 5 point ordinal scale-None, mild, moderate, severe , extremely severe Clinical status expressed in percentage of subjects reporting each severity rating on a 5-point ordinal scaleTimepoint: 24 hrs. of treatment regimen, patient to be observed daily for till the time of discharge or day 10 whichever is earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in National Early Warning Score (SpO2, respiratory rate, heart rate, fever) Requirement of admission to intensive care unit No. of days of hospitalization Requirement of hospitalizationTimepoint: 24 hrs. of treatment regimen, patient to be observed daily for till the time of discharge or day 10 whichever is earlier | — |
Countries
India
Contacts
Mprex Healthcare Pvt Ltd