Rapid diagnostic test for the detection of COVID-19 antibodies
Phase 4
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/07/026469
- Lead Sponsor
- HealthCubed India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Negative SARS-CoV-2 subjects:
Aged 18 years of age or over
Negative SARS-CoV-2 result by RT-PCR
Positive SARS-CoV-2 subjects:
Aged 18 years of age or over
Positive SARS-CoV-2 result by RT-PCR
Requires hospitalisation
10 days post onset of symptoms
Exclusion Criteria
Negative SARS-CoV-2:
• Aged less than 18 years
• Outpatients
• History of known immune suppression
• Participation in any other trial
Positive SARS-CoV-2:
• Aged less than 18 years
• Patients unlikely to survive >28 days in view of attending medical team
• Outpatients
• Anticipated transfer to another hospital within 72 hours
• History of known immune suppression
• Less than 10 days since the onset of symptoms
• Participation in any other trial
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method