Health Condition 1: A90- Dengue fever [classical dengue]
Conditions
Interventions
Intervention1: Dengue mAb 3 mg/kg: Calculated dose will be diluted with formulation buffer as required to make 40 mL volume to be administered over a period of up to 2 hours as IV infusion.
Interventi
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1.Patient meets criteria for Severe Dengue – severe plasma leakage leading to Dengue Shock Syndrome (DSS), fluid accumulation with respiratory distress, severe bleeding as assessed by clinician, severe organ involvement – AST/ALT >1000 U/L, impaired consciousness, and multi-organ dysfunction. 2.Hemoglobin 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants with causally related SAEs 2.Virological log reduction (VLR) of infective dengue virus as assessed by NS1 cell-based titration (NSET) assayTimepoint: 1. Throughout study duration of 180 days 2. 24 hours after administration of Dengue mAb | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with negative dengue virus isolation as assessed by NSET assayTimepoint: at 24, 48, 72, 96 and 168 hours after administration of Dengue mAb;Proportion of participants with negative dengue virus isolation as assessed by NSET assay by serotypeTimepoint: at 24, 48, 72, 96 and 168 hours after administration of Dengue mAb;Proportion of participants with negative dengue virus isolation as assessed by NSET assay by baseline serostatus (primary or secondary dengue)Timepoint: at 24, 48, 72, 96 and 168 hours after administration of Dengue mAb;Infective dengue VLR as measured by NSETTimepoint: at 8, 48, 72, 96 and 168 hours after Dengue mAb administration | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni MD
Serum Institute of India Pvt. Ltd.
Outcome results
None listed