The efficacy of rupatadine in reducing the incidence of dengue haemorrhagic fever and complications in patients with dengue fever: a randomised, double blind, placebo controlled trial

INTERVENTION: The study will be carried out at the National Infectious Diseases Hospital, Sri Lanka. Participants will be allocated using simple randomization. Arm A (intervention arm): 40mg rupatadine (4 tablets of 10mg rupatadine), daily for a duration of 5 days. Arm B (control arm): 4 tablets of matching placebo, daily for a duration of 5 days Participants in both arms will be managed according to current national guidelines, Ministry of Health, Sri Lanka. Participants, health care providers and data collectors will be blinded to the intervention status. CONDITION: Dengue PRIMARY OUTCOME: Reduction in proportion of individuals who are treated with rupatadine who develop DHF (fluid leakage), as determined by; ; 1. A rise in the haematocrit of >20% from the baseline; ; 2. Presence of pleural effusions or ascites by ultra sound scan (for in ward patients) SECONDARY OUTCOME: Reduction in complications ; ; 1. Reduction in liver failure (prolonged prothrombin time of 4‐6 seconds or more and INR of >1.5 in the absence of any previously known liver disease ; ; 2. Reduction in development of shock: Shock will be defined as a pulse pressure of >20 mmHg or a drop in the systolic blood pressure of 30mmHg or more ; ; 3. Reduction in need of colloids: use of dextran in patients having significant fluid leakage as per National Guidelines ; ; 4. Reduction in need of blood transfusion/s: as per National Guidelines. Use of even 1 blood transfusion will be considered as the patient having significant fluid leakage ; ; 5. Reduction in duration of the illness. The first day of the illness will be defined as the day in which the patient developed fever. The day of recovery will be defined when all of the following 3 criteria are fulfilled: ; • patient afebrile for 24 hours ; • platelet counts of >50,000 cells/mm3 or a rise of 20% from the lowest value ; • return of the haematocrit to the patients baseline ; ; 6. Reduction in sleep disturbances: assessed by an eight point scoring system – the Sleep Condition Indicator (Espie et al., 2014) ; INCLUSION CRITERIA: 1. Male and female patients aged between 18‐60 years 2. Dengue infection confirmed by a positive dengue NS1 antigen detection test (rapid immununochromatographic assays (rapid strip tests) at the out patient department) 3. Duration of fever: <3 days 4. No evidence of vascular leak.