Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Glutathione 600 mg with Standard of Care: Patients will receive 2400 mg of intervention product as a loading dose and then 1200mg every 12 hourly for 7 days as an intravenous injection.
Sponsors
Zuventus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR. 2. Patients with moderate COVID-19 (According to Clinical Management Protocol: COVID 19, Govt. of India). -Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 -Respiratory Rate �24 per minute -Pneumonia with no signs of severe disease 3. Symptomatic adult male or non-pregnant female (�18 years) 4. Voluntarily participating in the clinical study and patients or legal representative willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Asymptomatic COVID-19 patients. 2. Patients with known hypersensitivity to glutathione or related drugs. 3. Patients enrolled in any other investigational drug studies in COVID-19. 4. Severe infection and need for invasive or non-invasive ventilator support. 5. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients showing clinical improvement on the WHO 7-point ordinal scale.Timepoint: Day 1, 2, 3, 4, 5, 6 and 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of patients reporting incidences of adverse events 2. Mean change in the WHO 7-point ordinal scale 3. Proportions of patients reporting each severity rating on WHO 7-point ordinal scale 4. Duration of hospitalization 5. Duration and incidence of new non-invasive ventilation or high flow oxygen useTimepoint: Day 1, 2, 3, 4, 5, 6 and 7 | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Limited
Outcome results
None listed