A Phase II, Single blind, Randomized, Parallel group, Dose ranging, Single Dose Study of Dengue Monoclonal antibody (Dengue mAb) inAdults with Dengue Fever

Serum Institute of India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年1月9日

试验速览

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•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.

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