VISION Study

Evaluation of the effect and safety terapeutic of Jusvinza in severe patients with COVID-19

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000393

Enrollment

108

Registered

2021-10-26

Start date

2021-10-30

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress by Covid-19 COVID-19 SARS-CoV-2

Interventions

Standard therapy (Control group): Standard therapy. Jusvinza (Experimental group): Standard therapy + Jusvinza Standard therapy: Application of all the measures approved in the MINSAP protocol for the

Peptides

Administration, Intravenous

Jusvinza

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age = 19. 2. Virologial diagnosis by RT-PCR to SARS-Cov-2. 3. Patients with serious status. 4. Willingness of the patient through informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with kidney disease on hemodialysis. 2. Known hypersensitivity to any of the components of the formulations under study 3. Pregnancy or breastfeeding.

Design outcomes

Primary

Measure	Time frame
Progression to critical state (It will measured like Yes/No, established from the criticality state, and the main evaluation measure is based on the PO2 / Fi02 relationship). Measurement time: during the stay in the ICU.	—

Secondary

Measure	Time frame
1. Mortality (Proportion of patients to die and their causes). Measurement time: during hospital stay. 2. Stay during serious condition (Time, in days, from inclusion in the trial to discharge from severe condition or progression to critical condition). Measurement time: At discharge from serious condition or progression to critical condition 3. Stay during critical condition (Time, in days, from the critical condition is established until the extubation or fatal outcome). Measurement time: At extubation moment or fatal outcome 4. Hospital stay (Time, in days, from hospital admission to discharge or fatal outcome). Measurement time: At hospital discharge or fatal outcome 5. Changes in the values of the biomarkers (Modification of the values in the absolute count of lymphocytes, C-reactive protein, erythrocyte sedimentation rate, lactate dehydrogenase – LDH). Measurement time: before time 0, 48 hours, 96 hours and, end of treatment. 6. Hyperinflammation and coagulopathy score parameters (Temperature, visceromegaly, cytopenias, triglycerides, aspartate aminotransferase - TGO, fibrinogen, ferritin, D-dimer). Measurement time: before time 0, 48 hours, 96 hours and, end of treatment. 7. Immune response in serum (It will measure through the determination of cytokines: IL-6, IL-10, IL-17, TNF, and INF?, through commercial ELISAs). Measurement time: before time 0, 96 hours and, end of treatment. 8. Phenotype of T cells (It will measure through the determination of the TH1, TH17 and Treg phenotypes, through flow cytometry). Measurement time: before time 0 and, end of treatment. 9. Imaging response (The evolution of lung lesions will be evaluated by chest X-ray, TAC or pulmonary ultrasound). Measurement time: after starting treatment (and when clinically indicated). 10. Adverse Events-AE (They will be measured as: -Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Causality relationship (not related, doubtful ,	—

Measure

Time frame

1. Mortality (Proportion of patients to die and their causes). Measurement time: during hospital stay. 2. Stay during serious condition (Time, in days, from inclusion in the trial to discharge from severe condition or progression to critical condition). Measurement time: At discharge from serious condition or progression to critical condition 3. Stay during critical condition (Time, in days, from the critical condition is established until the extubation or fatal outcome). Measurement time: At extubation moment or fatal outcome 4. Hospital stay (Time, in days, from hospital admission to discharge or fatal outcome). Measurement time: At hospital discharge or fatal outcome 5. Changes in the values of the biomarkers (Modification of the values in the absolute count of lymphocytes, C-reactive protein, erythrocyte sedimentation rate, lactate dehydrogenase – LDH). Measurement time: before time 0, 48 hours, 96 hours and, end of treatment. 6. Hyperinflammation and coagulopathy score parameters (Temperature, visceromegaly, cytopenias, triglycerides, aspartate aminotransferase - TGO, fibrinogen, ferritin, D-dimer). Measurement time: before time 0, 48 hours, 96 hours and, end of treatment. 7. Immune response in serum (It will measure through the determination of cytokines: IL-6, IL-10, IL-17, TNF, and INF?, through commercial ELISAs). Measurement time: before time 0, 96 hours and, end of treatment. 8. Phenotype of T cells (It will measure through the determination of the TH1, TH17 and Treg phenotypes, through flow cytometry). Measurement time: before time 0 and, end of treatment. 9. Imaging response (The evolution of lung lesions will be evaluated by chest X-ray, TAC or pulmonary ultrasound). Measurement time: after starting treatment (and when clinically indicated). 10. Adverse Events-AE (They will be measured as: -Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Causality relationship (not related, doubtful ,

—

Countries

Cuba

Contacts

Public ContactJulio Baldomero Hernandez

Center for Genetic Engineering and Biotechnology (CIGB)

julio.baldomero@cigb.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026