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NCT Number: NCT06744777

The Comparative Efficacy of Standard Treatment Plus Ribavirin vs Standard Treatment Alone in Preventing Clinically Significant Hemorrhage in Patients With Dengue Fever

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kohat Institute of Medical Science, Kohat, KPK, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ribavirin

Drug

Ribavirin is an antiviral medication administered as part of the intervention arm. It will be provided orally in a dosage of 15 mg/kg body weight twice daily (BD) for a duration of 7 days. The drug has demonstrated efficacy in vitro and in vivo against RNA viruses, including dengue, through mechanisms such as inosine monophosphate inhibition and immunomodulation.

standard treatment

Other

The standard treatment for dengue fever includes supportive care measures aimed at managing symptoms and preventing complications. These measures typically involve:

Intravenous (IV) fluid therapy for rehydration and maintaining hemodynamic stability.

Platelet transfusion as needed, based on clinical assessment and platelet counts.

Antipyretics for fever management (excluding non-steroidal anti-inflammatory drugs to prevent bleeding risks).

Continuous monitoring of vital signs and blood parameters, including platelet counts and hematocrit levels.

No antiviral drugs or additional pharmacological interventions are included in the standard treatment protocol.

Primary outcomes

  1. Prevention of Clinically Significant Hemorrhage

    Time frame: Up to 7 days post-treatment initiation

    Evaluate the efficacy of Ribavirin plus standard treatment compared to standard treatment alone in preventing clinically significant hemorrhage (WHO Grade 2 or higher).

Secondary outcomes

  1. Platelet Count Changes

    Time frame: At baseline, Day 4, and Day 7 post-treatment initiation.

    Compare levels of platelets count between the intervention and control groups.

  2. Length of Hospital Stay

    Time frame: From hospital admission to discharge (up to 14 days).

    Evaluate and compare the duration of hospitalization in the intervention and control groups.

  3. C-reactive protein

    Time frame: At baseline, Day 4, and Day 7 post-treatment initiation.

    Compare the C-reactive protein in between intervention and control group

  4. Serum ferritin

    Time frame: At baseline, Day 4, and Day 7 post-treatment initiation.

    Compare the serum ferritin in between intervention and control group

  5. Lactate dehydrogenase

    Time frame: At baseline, Day 4, and Day 7 post-treatment initiation.

    Compare levels of lactate dehydrogenase between the intervention and control groups.

Other outcomes

  1. Adverse Events and Tolerability of Ribavirin

    Time frame: During the 7-day treatment period and up to 30 days post-treatment follow-up.

    Document adverse events, including side effects, and assess the tolerability of Ribavirin in the intervention group.

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Registry information

Official study title

The Comparative Efficacy of Standard Treatment Plus Ribavirin vs Standard Treatment Alone in Preventing Clinically Significant Hemorrhage in Patients With Dengue Fever: A Double-blind, Randomized Control Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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