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Adaptive Dengue Antiviral Platform Trial

ConditionsDengueAntiviral Drugs
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10+
SponsorOxford University Clinical Research Unit, Vietnam

About this trial

This is a randomized, open-label adaptive platform trial aiming to screen the antiviral effectiveness of the experimental drug(s) in early dengue infection

* Primary objectives:

* To determine the antiviral effectiveness of the experimental drug(s) in early dengue infection * To assess the safety and tolerability of the experimental drug(s) in dengue patients * Secondary objective:

* To assess the effect of the experimental drug(s) in dengue patients on physiological, clinical and virological parameters

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female or male patients with a clinical diagnosis of dengue virus infection and less than 48 hours of fever

Positive NS1 rapid diagnostic test

>= 10 years or ≥ 18 years of age (depending on license of therapeutic being evaluated)

Patient is able to give written informed consent or assent for full participation in the study.

Disqualifiers

Meets criteria for severe dengue at baseline (severe plasma leakage leading to dengue shock syndrome, fluid accumulation with respiratory distress, severe bleeding, severe organ involvement - AST/ALT>1000 U/L, impaired consciousness, multiple organ dysfunction)

Pregnancy (either clinically confirmed or by urine dipstick for human chorionic gonadotrophin hormone)

Breastfeeding women

Localising features suggesting an alternative/additional diagnosis, e.g. pneumonia, sepsis

Trial design

Design model

Sequential

Treatments tested in this trial

  • Molnupiravir 400 mg

    Drug

    This is an antiviral drug (an RNA dependent RNA polymerase inhibitor, with broad spectrum antiviral activity) currently approved for use in treatment for COVID-19 patients. In this trial, its antiviral effectiveness on the early phase of dengue virus infection will be assessed.

  • VIS513 (a monoclonal antibody)

    Drug

    VIS513 is an engineered humanised monoclonal antibody produced by recombinant DNA technology in a mammalian cell (i.e. Chinese hamster ovary) line. It was discovered in the USA by Visterra Inc and subsequently technology for manufacturing and further development was transferred to Serum Institute of India Pvt. Ltd., Pune, India. It has shown potent, specific neutralization of all four serotypes of DENV.

  • Remdesivir 100mg

    Drug

    Remdesivir (GS-443902) is a nucleoside analogue - RNA dependent RNA polymerase inhibitor.

Treatment groups

500 Participants
are divided into 4 treatment groups
Group A: Standard of care (arm A)No intervention 0 interventions
Group B: Molnupiravir (arm B)Experimental treatment 1 intervention
Group C: Monoclonal antibody (arm C)Experimental treatment 1 intervention
Group D: Remdesivir (arm D)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Viral clearance rate

Rate of viral clearance estimated under a hierarchical log-linear model fit to the serial viral load measurements over 5 days after enrolment. The viremia kinetics will be measured using the qRT-PCR assay, which will be performed on samples taken twice a day from day 1 to day 3 of study and then once a day on days 4 and 5 of study (total 9 samples per patient).

Time frame
From randomization until day 5 of study
2

Number of AEs (grade 3, 4 and 5)

All patients will be followed up daily until discharge and then at around days 30 after randomization to collect information on clinical progress of dengue illness and any adverse events occurring during the study course. All AEs and SAEs will be recorded.

Time frame
Until day 30 post-enrolment

Secondary outcomes

1

Area under the viremia curve

Area under the curve (AUC) of the serial viremia measurements during the first 5 days of study

Time frame
From randomisation until day 5 of study
2

Viral log reduction

Reduction of viremia at the 24 and 48 hours compared to baseline

Time frame
up to 48 hours of study
3

NS1 clearance time

Time to NS1 clearance as estimated under a non-linear model

Time frame
up to day 5
4

Number of patients progress to severe dengue (WHO 2009 criteria)

All patients will be followed up daily until discharge to collect information about the clinical progress of dengue

Time frame
From enrolment until discharge, assessed up to 30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oxford University Clinical Research Unit, Vietnam

Lead sponsor

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Collaborator

University Malaya Medical Centre, Malaysia

Collaborator

Source ClinicalTrials.gov
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