Coronavirus infections
Conditions
Interventions
Adaptive, multicentre, double-blind, randomised, placebo-controlled study. Participants with suspected CoV-2 SARs infection and who declare availability for treatment and daily care (telemedicine, hom
but if the participant is not hospitalised, this follow-up will be by outpatient care, by video call or by
Sponsors
Vice-Presidência de Pesquisa e Coleções Biológicas - VPPCB
Vice-Presidência de Pesquisa e Coleções Biológicas - VPPCB
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants with a diagnosis of COVID-19 confirmed by PCR-RT or positive rapid antigen test; participants aged 18 years or older; participants with a score between 1 and 3 on the WHO Clinical Progression Scale; participants with a score greater than or equal to 10 on the CALL Score; consent from men to use barrier contraception during the study and one (1) week after the end of the use of study medication if the partner is of the opposite sex; informed consent form signed by the participant; able to receive oral medication and attend protocol visits
Exclusion criteria
Exclusion criteria: Non-hysterectomised women of childbearing age; symptomatic patients for more than 72 hours; participants with severe liver failure equivalent to Child-Pugh grade C and advanced renal disease requiring haemodialysis or grade 3 or 4 according to the classification of the severity grade of adverse events of the Common Terminology Criteria for Adverse Events (CTCAE, version 5), or still, at the physician's discretion; participants taking antiretroviral drugs or pyrazinamide, repaglinide, theophylline, famciclovir and sulindac; disease progression greater than 5 (WHO Score) with need for intensive care; participants with a medical condition whose ability to understand is reduced, such as Down's syndrome, autism, intellectual disability, neurological disorders, dementia, etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in SARS-CoV-2 viral load is expected in populations at increased risk as measured by qPCR (viral clearance) | — |
Secondary
| Measure | Time frame |
|---|---|
| A faster normalisation of symptoms is expected in participants with mild to moderate disease, i.e. who maintain this clinical profile after the end of study treatment. A reduction in the time to viral elimination and viral culture positivity is also expected. Evaluation of the frequency of adverse events and viral genotyping will also be assessed | — |
Countries
Brazil
Contacts
Public ContactJayme Fernandes
Vice-Presidência de Pesquisa e Coleções Biológicas - VPPCB
Outcome results
None listed