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Study to assess safety and efficacy of Inj Sepsivac in patients of Covid-19

Observational study to assess safety and efficacy of Inj Sepsivac in patients of Covid-19 at R D Gardi Medical College, Ujjain, India

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025350
Enrollment
50
Registered
2020-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Inj. Sepsivac: 0.3 ml/day of Inj. Sepsivac will be administered as intra-dermal injections for three consecutive days as 0.1ml x 3 injections at different sites along with standard ther

Sponsors

R D Gardi Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients between the age of 18 â?? 65 years diagnosed to have Covid19 infection confirmed by RTPCR assay, and 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

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.

Design outcomes

Primary

MeasureTime frame
Clinical improvement, as defined by live discharge from the hospital, a decrease of at least 2 points from baseline on a modified ordinal scale (as recommended by the WHO R&D Blueprint Group) Conversion of Covid19 status to negativeTimepoint: 28 days

Secondary

MeasureTime frame
1. Overall safety of the study drug 2. Duration of hospitalization 3. Improvement in the abnormal laboratory values Timepoint: 28 days

Countries

India

Contacts

Public ContactDr Ashish Pathak

R D Gardi Medical College

drashish.jpathak@gmail.com9302239899

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026