Efficacy and safety of Jusvinza treatment in patients with acute respiratory distress syndrome. Phase II/III

Phase II/III, adaptive, randomized, placebo-controlled study to evaluate the efficacy and safety of Jusvinza treatment in adult patients with acute respiratory distress syndrome - DANIELA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000422

Enrollment

Unknown

Registered

2023-04-24

Start date

2023-05-22

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 Syndrome

Interventions

Phase 2: two Jusvinza treatment groups and one Placebo group will be included. Group 1 (experimental). Jusvinza 1 mg every 8 hours intravenously. Group 2 (experimental). Jusvinza 2 mg every 8 hours in

Peptides

Placebos

Respiration, Artificial

Administration, Intravenous

Jusvinza

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with acute respiratory distress syndrome (according to the Berlin criteria) 2) Patients over 19 years of age or older. 3) Patients with invasive or non-invasive mechanical ventilation.

Exclusion criteria

Exclusion criteria: 1) Pregnant or postpartum patients 2) Patients whose relatives do not give their informed consent in writing 3) Patients with a do not resuscitate order 4) Patient with a diagnosis of ARDS of more than 72 hours of evolution 5) Patients who in the last three months have received treatment with JAK inhibitor, IL-6 receptor inhibitor, anti-IL-6 monoclonal antibody (eg Tocilizumab), anti-IL-1 monoclonal antibody (eg Anakinra), Nimotuzumab or Itolizumab 6) Patient currently participating in another clinical trial with Jusvinza 7) Patients with current compassionate use of Jusvinza 8) Patients with end-stage disease 9) Patients with chronic bed rest for more than 1 month 10) Hypersensitivity to the product or any of its components.

Design outcomes

Primary

Measure	Time frame
Phase 2: 1) PaO2/FiO2 ratio (measurement of the value in mmHg of the PaO2/FiO2 ratio). Measurement time: to the 7th day from randomization. 2) Time of invasive mechanical ventilation (Number of days with invasive mechanical ventilation). Measurement time: from randomization. Phase 3: Mortality (Subject alive or deceased). Measurement time: at 28 days from randomization.	—

Secondary

Measure	Time frame
1) Respiratory function variables (Peak inspiratory pressure (value returned by the mechanical ventilator in cm H2O), Plateau pressure (value returned by the mechanical ventilator in cm H2O), Positive end-expiratory pressure (PEEP) (value returned by mechanical ventilator in cm H2O), Respiratory conduction pressure (Calculated as the difference between plateau pressure and PEEP. Value in cm H2O), Tidal volume (value given by the mechanical ventilation equipment in mL), Minute volume ( value given by the mechanical ventilation team in L. It is calculated as: tidal volume * respiratory frequency), Dynamic compliance (compliance) of the respiratory system (value given by the mechanical ventilation team in mL/ cm H2O. It is calculated as the volume current/ (peak inspiratory pressure – PEEP), Static compliance (compliance) of the respiratory system (value given by the mechanical ventilation team in mL/ cm H2O, It is calculated as the tidal volume/ (pressure plateau – PEEP), Total respiratory rate (value given by the mechanical ventilation equipment in breaths/minute), Mechanical power (Value measured in Joules. It is calculated: a) For volume-controlled mode: 0.098 * VC * (PIP – Pcond/2) * FR, b) For pressure-controlled mode: 0.098 * VC * (Pcond + PEEP) * FR), Index of ventilation (Calculated as follows: Ventilation rate = Respiratory rate × (Peak inspiratory pressure - PEEP) × PaCO2/ 1000)), Inspiratory fraction of oxygen (value given by the mechanical ventilation team in %). Measuring time: Daily. At baseline and until the patient is withdrawn from mechanical ventilation (up to 28 days of follow-up). 2) Gasometric variables (pH (value given by gasometry), oxygen saturation in arterial blood (value given by gasometry in %), partial pressure of oxygen in arterial blood (value given by gasometry in mm Hg), partial pressure of carbon dioxide in arterial blood (value given by blood gases in mm Hg), bicarbonate (value given by blood gases in mm Hg)). Measurement time: At th	—

Measure

Time frame

1) Respiratory function variables (Peak inspiratory pressure (value returned by the mechanical ventilator in cm H2O), Plateau pressure (value returned by the mechanical ventilator in cm H2O), Positive end-expiratory pressure (PEEP) (value returned by mechanical ventilator in cm H2O), Respiratory conduction pressure (Calculated as the difference between plateau pressure and PEEP. Value in cm H2O), Tidal volume (value given by the mechanical ventilation equipment in mL), Minute volume ( value given by the mechanical ventilation team in L. It is calculated as: tidal volume * respiratory frequency), Dynamic compliance (compliance) of the respiratory system (value given by the mechanical ventilation team in mL/ cm H2O. It is calculated as the volume current/ (peak inspiratory pressure – PEEP), Static compliance (compliance) of the respiratory system (value given by the mechanical ventilation team in mL/ cm H2O, It is calculated as the tidal volume/ (pressure plateau – PEEP), Total respiratory rate (value given by the mechanical ventilation equipment in breaths/minute), Mechanical power (Value measured in Joules. It is calculated: a) For volume-controlled mode: 0.098 * VC * (PIP – Pcond/2) * FR, b) For pressure-controlled mode: 0.098 * VC * (Pcond + PEEP) * FR), Index of ventilation (Calculated as follows: Ventilation rate = Respiratory rate × (Peak inspiratory pressure - PEEP) × PaCO2/ 1000)), Inspiratory fraction of oxygen (value given by the mechanical ventilation team in %). Measuring time: Daily. At baseline and until the patient is withdrawn from mechanical ventilation (up to 28 days of follow-up). 2) Gasometric variables (pH (value given by gasometry), oxygen saturation in arterial blood (value given by gasometry in %), partial pressure of oxygen in arterial blood (value given by gasometry in mm Hg), partial pressure of carbon dioxide in arterial blood (value given by blood gases in mm Hg), bicarbonate (value given by blood gases in mm Hg)). Measurement time: At th

—

Countries

Cuba

Contacts

Public ContactMaria Dominguez Horta

Center for Genetic Engineering and Biotechnology (CIGB).

mcarmen.dominguez@cigb.edu.cu

Outcome results

None listed

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