CTRI/2020/07/026839CompletedPhase 3
A randomised double blind trial to evaluate the activity of SSV Formulation for management of SARS-CoV-2 Infection (COVID-19)
Shreepad Shree Vallabh SSV Phytopharmaceuticals0 sites200 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Quarantine/non hospitalized or hospitalized and fulfils WHO case definition, including a positive RT-PCR confirmed COVID-19 illness.
- •Age more than 18 & less than 65 years of either sex.
- •Mild to Moderately COVID-19 disease (NEWS score less than or equal to 8).
- •Patients with oxygen saturation (SpO2) less than 95%.
- •Respiratory rate is more than 20/min.
- •Pulse rate more than 90/min.
- •Imaging evidence of lung infection in the form of Reticulonodular opacities, ground-glass opacities and consolidation.
Exclusion Criteria
- •Pregnant women.
- •Breastfeeding women.
- •Requiring ICU admission at screening.
- •Patients above 65 years of age and below 18 Years.
- •Past History of MI, Epileptic episodes.
- •Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at screening.
- •Asymptomatic patients.
- •Patients unwilling for informed consent.
- •Patients with prolonged QTc interval on ECG.
- •In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- •Participant with any immunosuppressive condition or hematological disease.
- •Participation in any other A.S.U and H protocol.
Investigators
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