linastatin for COVID-19 in patients with breathlessness
- Conditions
- Health Condition 1: J80- Acute respiratory distress syndromeHealth Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/06/025704
- Lead Sponsor
- Bharat Serums and Vaccines ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Hospitalized adult aged >18-65 years inclusive
2.Confirmed COVID-19 infection (RT â??PCR-test)
3.Symptoms of mild or moderate ARDS
(Ref: MoHFW/ ICMR Revised guidelines on clinical management of COVID-19- 31Mar2020)
1.Patients with history of HIV/HCV/HBV positive or immunocompromised or TB
2.Patients with significant co-morbidities at screening, as judged by the treating Investigator
3.Moribund state in which death is perceived to be imminent (<=48 hours)
4.Known hypersensitivity to any component of the investigational product
5.Pregnant or nursing (lactating) women.
6.Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
7.Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs/convalescent plasma (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).
8.Participation in any other clinical study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method