Chikungunya virus infection in post-acute and chronic stages.
Conditions
Interventions
Group Jusvinza (Experimental): Jusvinza dose 0.5 mg, subcutaneous route (9 doses in total). Administration schedule: One daily dose (every 24 hours) for 6 consecutive days, followed by three weekly do
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), Havana.
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Fulfillment of diagnostic criteria. 2. Patients in the post-acute stage (21–90 days after onset of acute symptoms) or chronic stage (>90 days) of the disease. 3. Moderate or high disease activity at study entry, defined as a CDAI index > 10.0. 4. Presence of persistent arthritis affecting at least one joint and interfering with quality of life or daily functionality. 5. Age = 19 years. 6. Patient’s willingness to voluntarily participate in the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Patients under treatment with Jusvinza or another investigational product, or who have received other biological therapy within the last three months. 2. Known hypersensitivity to any of the components of the study formulation. 3. Active concomitant infections that may explain joint symptoms (e.g., active tuberculosis). 4. Decompensated chronic, autoimmune, or endocrine-metabolic diseases at the time of inclusion. 5. Pregnancy or breastfeeding (reported). Women of reproductive age who do not use contraceptives or are planning pregnancy. 6. Evident mental incapacity to provide consent and act in accordance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of painful and inflammatory clinical manifestations The assessment will be performed according to the CDAI (Clinical Disease Activity Index), considering remission when 10.0 to 22.0; and high activity when > 22.0. Assessment time points: Baseline (Time 0), Week 2 (7 days [± 1 day] after the 6th dose); Day 45 (± 3 days) andWeek 12 (± 3 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of pain intensity by the patient. For the evaluation scale, a score (0–10) will be considered, with the following categories: no pain (0), mild pain (2), moderate pain (4), severe pain (6), very severe pain (8), and maximum pain (10). Assessment time points: Baseline (Time 0), Week 2 (7 days [± 1 day] after the 6th dose), Day 45 (± 3 days), Week 12 (± 3 days). 2. Functional capacity. This will be assessed using the HAQ-DI scale, considering no disability when 0.000; mild to moderate between 0.000 and 1.000; moderate to severe from 1.001 to 2.000; and severe to very severe when > 2.000. Assessment time points: Baseline (Time 0), Week 2 (7 days [± 1 day] after the 6th dose), Day 45 (± 3 days), Week 12 (± 3 days). 3. Safety. The occurrence of clinical adverse events will be evaluated. The type, duration, intensity, causality relationship, management, and outcome will be described. Patients will be evaluated during the first hour following administration of the Jusvinza peptide, in person at the clinical site, and will be instructed on the need to contact the FENIK-3 study research team in case of any medical eventuality. Safety monitoring will be carried out throughout the entire duration of the trial (12 weeks). 4. Immunological evaluation. This will include lymphocyte subpopulations (CD4+, CD25+, and CD127–) and quantification of proinflammatory cytokines (TNF alpha, IFN gamma, IL-6, IL-17). Assessment time points: Baseline (Time 0, before administration of the first dose of Jusvinza), Day 45, and Week 12. | — |
Countries
Cuba
Contacts
Public ContactGiselle Blanco Ferran
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed