CTRI/2020/05/025350
Not yet recruiting
Phase 2
Observational study to assess safety and efficacy of Inj Sepsivac in patients of Covid-19 at R D Gardi Medical College, Ujjain, India
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- R D Gardi Medical College
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients between the age of 18 â?? 65 years diagnosed to have Covid19 infection confirmed by RTPCR assay,
- •any one or more of the following
- •1\. Either an oxygen saturation of 94% or less while the patient was breathing ambient air or a need for oxygen support
- •2\. Creatinine clearance above 30 ml per minute
- •3\. Serum levels of ALT and AST less than five times the upper limit of the normal range
- •4\. Requirement of vasopressor
Exclusion Criteria
- •1\.Pregnant or nursing female.
- •2\.Patient previously enrolled into similar study.
- •3\.Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or HIV.
- •4\.Patients not likely to complete the trial as per judgment of the investigator.
Outcomes
Primary Outcomes
Not specified
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