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

June 23, 2025 updated by: Khyber Medical University Peshawar

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
284

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • KPK
      • Kohat, KPK, Pakistan
        • Kohat Institute of Medical Science
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, Pakistan, 09152
        • Lady Reading Hospital
      • Peshawar, Khyber Pakhtunkhwa, Pakistan
        • Gandhara Medical Hospital
      • Swābi, Khyber Pakhtunkhwa, Pakistan
        • Medical Complex Swabi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ribavirin + Standard Treatment
Participants in this group will receive the standard treatment for dengue fever alongside Ribavirin. Ribavirin will be administered orally at a dose of 15 mg/kg body weight twice daily (BD) for a total duration of 7 days.
Drug: Ribavirin
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.
Other: Standard Treatment

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.
Active Comparator: Standard Treatment Alone
Participants in this group will receive only the standard treatment for dengue fever, which includes supportive care such as intravenous fluids and platelet transfusions, as required. No additional pharmacological intervention will be provided.
Other: Standard Treatment

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Up to 7 days post-treatment initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From hospital admission to discharge (up to 14 days).
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.
At baseline, Day 4, and Day 7 post-treatment initiation.
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
At baseline, Day 4, and Day 7 post-treatment initiation.
Serum ferritin
Time Frame: At baseline, Day 4, and Day 7 post-treatment initiation.
Compare the serum ferritin in between intervention and control group
At baseline, Day 4, and Day 7 post-treatment initiation.
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.
At baseline, Day 4, and Day 7 post-treatment initiation.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
During the 7-day treatment period and up to 30 days post-treatment follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Khyber Medical University Peshawar

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Said Amin, MBBS,FCPS, Department of Medicine Hayatabad Medical Complex Peshawar
  • Principal Investigator: Sheraz Fazid, MBBS,MPH, Institute of Public Health and Social Science, Khyber Medical University Peshawar
  • Principal Investigator: Noman Arif, MBBS, Institute of Public Health and Social Science, Khyber Medical University Peshawar
  • Principal Investigator: Akhtar Sherin, MBBS,MHR,PHD, Kohat Institute of Medical Science Peshawar Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMU/DIR/CTU/2024/012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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