Dengue, Chikungunya Fever
Conditions
Interventions
The intervention group will use Molnupiravir 800mg, twice a day for 5 days, orally. The placebo group will use a similar tablet without the active ingredient. Each group will require approximately 50
D27.505.519.389.675
Sponsors
Universidade Federal de Minas Gerais
Instituto Nacional de Ciência e Tecnologia Em Dengue
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: A patient who understands the procedures, is willing and able to give informed consent for full participation in the study. The participant must be an adult between 18 and 65 years old at the time of consente and male or female. The participant has to present symptoms compatible with the diagnosis of an acute arboviral infection, including fever, myalgia, arthralgia or arthritis, headache, conjuntivitis, which began no later than 60 hours before the time of inclusion. The participant agrees and is able to adhere to all study procedures, including providing contact information and is available for follow up visits
Exclusion criteria
Exclusion criteria: Patients taking any chronic medication that may interact with Molnupiravir or have antiviral activity in the opinion of the study's principal investigator. Patients with any disease/chronic condition with significant comorbidity in the opinion of the study's principal investigator. Presenting clinically relevant laboratory abnormalities. Contraindication or hypersensitivity to molnupiravir. Current participation in another drug clinical trial. Evidence of another infectious condition that explains the current symptoms. And, for women, pregnancy, trying to become pregnant, or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viral clearance rate estimated from log10 viral density derived from Quantitative Polymerase Chain Reaction of peripheral blood samples collected daily from baseline (day 0) through day 4 for each therapeutic arm compared to the control receiving placebo;Rate of viral clearance | — |
Secondary
| Measure | Time frame |
|---|---|
| Viral clearance rate and measures of immune response, virus sequences and host genetics;Molnupiravir concentration in participants' blood;Time to symptom relief and duration of fever for Molnupiravir and placebo for both diseases;Hospitalization for any cause;Incidence of arthralgia, arthritis and neuropathy 3 and 6 months after symptom onset | — |
Countries
Brazil
Contacts
Public ContactMauro Teixeira
Universidade Federal de Minas Gerais
Outcome results
None listed