Study to evaluate the safety and efficacy of single-dose of intravenously administered Dengue monoclonal antibody in Adults with Dengue Fever
- Conditions
- Health Condition 1: A90- Dengue fever [classical dengue]
- Registration Number
- CTRI/2021/07/035290
- Lead Sponsor
- Serum Institute of India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Adults aged 18-60 years, men, or women.
2. Participants who give written informed consent.
3. History of fever, presenting within 48 hours from onset.
4. Positive NS1 test (strip test / rapid test) or positive for PCR for acute dengue virus infection
5. Participants who are willing to be hospitalized for 4 days (96 hours) post study drug infusion, and to comply with other study protocol requirements including attendance at
scheduled follow-up visits.
1.Patient meets criteria for Severe Dengue â?? severe plasma leakage leading to Dengue Shock Syndrome (DSS), fluid accumulation with respiratory distress, severe bleeding as assessed by clinician, severe organ involvement â?? AST/ALT >1000 U/L, impaired consciousness, and multi-organ dysfunction.
2.Hemoglobin < 10 g/dL, Absolute neutrophil count <500/mm3, Total leukocyte count <1500/mm3, and Platelet count <50,000/mm3
3.Known Hepatitis B, Hepatitis C and HIV infections.
4.Evidence or history of substance abuse including alcohol, or previous substance abuse within the last year.
5.Participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method