Safety and Preliminary Efficacy of Dengue Monoclonal Antibody in Adult Patients: A Randomized Clinical Trial
Abstract
Importance: Dengue outbreaks are increasing in frequency and intensity. In the absence of any specific treatment, a pan-serotype recombinant monoclonal antibody (Dengue-mAb) was tested in adult patients with dengue as a therapeutic option.
Objective: To assess the safety and effect of a single dose of Dengue-mAb on dengue viremia at different dose levels among patients with dengue.
Design, setting, and participants: A phase 2, single-blind, randomized, placebo-controlled clinical trial was conducted from September 19, 2021, to May 13, 2023, at 12 hospitals in India. Study participants were aged 18 to 60 years with dengue and a history of fever onset within 48 hours. Key exclusion criteria were severe dengue, hemoglobin less than 10 g/dL, absolute neutrophil count less than 500/mm3, total leukocyte count less than 1500/mm3, platelet count less than 50 000/mm3, and any other clinically significant disorders. Data were analyzed from January 11, 2024, to March 26, 2024.
Interventions: Participants were randomly allocated 1:1:1:1:1 using an interactive web response system to receive 1 of 4 dose levels of Dengue-mAb (3, 5, 7, or 9 mg/kg) or placebo by slow intravenous infusion.
Main outcomes and measures: Primary outcomes were reduction in viremia at 24 hours and causally related serious adverse events (SAEs). Secondary outcomes were RNAemia, fever, and hematologic and pharmacokinetic parameters.
Findings: A total of 250 participants were randomized, with 50 participants in each…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 250 participants or records.
Read the paper
Related studies
- Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial
- Effect of a Postoperative Multimodal Opioid-Sparing Protocol vs Standard Opioid Prescribing on Postoperative Opioid Consumption After Knee or Shoulder Arthroscopy: A Randomized Clinical Trial
- Comparison of the Post-Caesarean Analgesic Effect of Adding Dexmedetomidine to Paracetamol and Ketorolac: A Randomized Clinical Trial
- A triple-blind randomized clinical trial of different associations between dexamethasone and non-steroids anti-inflammatories for preemptive action in third molar extractions
- An open label randomized clinical trial of Indomethacin for mild and moderate hospitalised Covid-19 patients
- Oral paracetamol and/or ibuprofen for treating pain after soft tissue injuries: Single centre double-blind, randomised controlled clinical trial
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.