This study investigates the comparative efficacy of standard treatment plus Ribavirin versus standard treatment alone in preventing clinically significant hemorrhage among patients diagnosed with dengue fever. It is a double-blind, randomized control trial aimed at determining whether the addition of Ribavirin improves clinical outcomes, particularly reducing bleeding events.

Dengue fever, a significant public health concern, presents varying severity from asymptomatic to life-threatening complications such as hemorrhage or shock. This study evaluates the effectiveness of Ribavirin when combined with standard treatment in mitigating severe bleeding complications in dengue patients. Conducted at multiple public sector hospitals in Khyber Pakhtunkhwa, the trial employs a rigorous methodology, including block randomization, double-blinding, and predefined eligibility criteria. Outcomes include changes in bleeding grades, platelet counts, acute-phase reactants, and hospital stay length. The findings aim to inform policy decisions and enhance dengue fever management protocols.

Inclusion Criteria:

• Male and female patients aged 18 years and above.
• Hospitalized patients diagnosed with dengue fever, confirmed via:
• Positive Dengue NS1 antigen test
• Dengue IgM antibodies
• Dengue RNA PCR.
• Patients presenting with various severities of illness, as classified by the WHO dengue severity classification.

Exclusion Criteria:

• Patients taking antiplatelet or anticoagulant medications.
• Patients with known bleeding disorders (e.g., hemophilia, von Willebrand disease, end-stage renal disease, or liver cirrhosis).
• Patients with HIV undergoing antiviral therapy.
• Pregnant women.
• Patients with hypersensitivity to Ribavirin.
• Patients with WHO Grade 1 bleeding (few petechiae without clinical significance).

The de-identified individual participant data (IPD) will be made available to other researchers upon request. This includes data related to demographic information, baseline clinical characteristics, treatment interventions, and outcome measures. Personal identifiers will be removed to ensure participant confidentiality.

Data will become available 6 months after the publication of primary results and remain accessible for 5 years.

Requests for data sharing will be reviewed by the principal investigator and the ethics committee. Researchers must submit a formal application with a detailed study proposal, including objectives, methodology, and the intended use of the data. A data-sharing agreement will be required to ensure ethical use and data protection compliance.

Double-blind methodology, with randomization and treatment assignment concealed.