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Dengue FeverPhase 3NCT06744777

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

A Phase 3 study testing Ribavirin and Standard Treatment in people with Dengue Fever and Dengue Hemorrhagic Fever, run by Khyber Medical University Peshawar at 4 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ribavirin and Standard Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
284 participants
Where
4 sitesPakistan
Study dates
17 Dec 2024to 29 May 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

4 sites in 1 country.

Pakistan4 sites

  • Kohat Institute of Medical Science

    Kohat, KPK

  • Lady Reading Hospital

    Peshawar, Khyber Pakhtunkhwa, 09152

  • Gandhara Medical Hospital

    Peshawar, Khyber Pakhtunkhwa

  • Medical Complex Swabi

    Swābi, Khyber Pakhtunkhwa

Other trials in Pakistan

About this study

Official 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

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.

Read the 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.

Keywords
Dengue, Hemorrhage, Randomized Controlled Trial, Antiviral Therapy
Medical subject headings
Dengue, Severe Dengue, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RibavirinDrug

    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 TreatmentOther

    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.

Study groups in NCT06744777
Study groupRoleWhat they receive
Ribavirin + Standard TreatmentExperimentalParticipants 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.
Receives: Drug: Ribavirin; Other: Standard Treatment
Standard Treatment AloneActive comparatorParticipants 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.
Receives: Other: Standard Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevention of Clinically Significant Hemorrhage

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

    Measured: Up to 7 days post-treatment initiation

Secondary outcomes (5)

  1. Platelet Count Changes

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

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

  2. Length of Hospital Stay

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

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

  3. C-reactive protein

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

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

  4. Serum ferritin

    Compare the serum ferritin in between intervention and control group

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

  5. Lactate dehydrogenase

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start17 Dec 2024
  3. Primary completion28 Apr 2025
  4. Study completion29 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study employs a parallel group design, where participants are randomly assigned to one of two arms: an intervention group receiving standard treatment plus Ribavirin and a control group receiving standard treatment alone. This approach ensures that each participant is exposed to only one of the two interventions being compared. The study is designed to assess the comparative efficacy of Ribavirin in preventing clinically significant hemorrhage among dengue fever patients while minimizing confounding factors through randomization and blinding.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06744777
Sponsor's protocol ID
KMU/DIR/CTU/2024/012
Status last verified
Jun 2025
First submitted
17 Dec 2024
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Gutierrez E, Sanchez I, Diaz O, Valles A, Balderrama R, Fuentes J, Lara B, Olimon C, Ruiz V, Rodriguez J, Bayardo LH, Chan M, Villafuerte CJ, Padayachee J, Sun A. Current Evidence for Stereotactic Body Radiotherapy in Lung Metastases. Curr Oncol. 2021 Jul 15;28(4):2560-2578. doi: 10.3390/curroncol28040233.

    PubMed 34287274

  • Roy SK, Bhattacharjee S. Dengue virus: epidemiology, biology, and disease aetiology. Can J Microbiol. 2021 Oct;67(10):687-702. doi: 10.1139/cjm-2020-0572. Epub 2021 Sep 3.

    PubMed 34171205

  • Sharif N, Sharif N, Khan A, Dey SK. The Epidemiologic and Clinical Characteristics of the 2023 Dengue Outbreak in Bangladesh. Open Forum Infect Dis. 2024 Feb 2;11(2):ofae066. doi: 10.1093/ofid/ofae066. eCollection 2024 Feb.

    PubMed 38390460

  • Khan U, Azeem S. The rising toll of dengue cases in Pakistan every year: An incipient crisis. Ann Med Surg (Lond). 2022 Mar 31;76:103549. doi: 10.1016/j.amsu.2022.103549. eCollection 2022 Apr. No abstract available.

    PubMed 35495398

  • Gurugama P, Garg P, Perera J, Wijewickrama A, Seneviratne SL. Dengue viral infections. Indian J Dermatol. 2010;55(1):68-78. doi: 10.4103/0019-5154.60357.

    PubMed 20418983

  • Tewari K, Tewari VV, Mehta R. Clinical and Hematological Profile of Patients with Dengue Fever at a Tertiary Care Hospital - An Observational Study. Mediterr J Hematol Infect Dis. 2018 Mar 1;10(1):e2018021. doi: 10.4084/MJHID.2018.021. eCollection 2018.

    PubMed 29531658

  • Ajlan BA, Alafif MM, Alawi MM, Akbar NA, Aldigs EK, Madani TA. Assessment of the new World Health Organization's dengue classification for predicting severity of illness and level of healthcare required. PLoS Negl Trop Dis. 2019 Aug 20;13(8):e0007144. doi: 10.1371/journal.pntd.0007144. eCollection 2019 Aug.

    PubMed 31430283

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ribavirin and Standard Treatment in people with Dengue Fever and Dengue Hemorrhagic Fever, run by Khyber Medical University Peshawar at 4 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevention of Clinically Significant Hemorrhage (time frame: Up to 7 days post-treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06744777, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.

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