DALIA Study

Evaluation of the effect and safety of the CIGB-258 peptide in the treatment of seriously or critically ill patients due to COVID-19. (COVID-19)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000330

Enrollment

Registered

2020-08-11

Start date

2020-08-11

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

COVID-19 respiratory distress COVID-19

Interventions

- Group I: CIGB-258 peptide (Jusvinza, CIGB, Havana, Cuba) + standard therapy according to the interim algorithms for the care of COVID-19 established by the IMSS. Patients WITH mechanical ventilation

Peptides

Respiration, Artificial

Administration, Intravenous

Jusvinza, CIGB-258

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients aged = 18 years. 2) Virological diagnosis by RT-PCR of infection to SARS-CoV-2. 3) Patients in serious or critical condition. 4) Acute respiratory failure according to clinical and Berlin criteria (imaging and oxygenation). 5) Voluntariness of the patient through informed consent.

Exclusion criteria

Exclusion criteria: 1) Previous treatment with JAK inhibitor, tocilizumab or other anti-IL6R or IL-6, IL-1 inhibitor (Anakinra). 2) Patients with kidney disease on hemodialysis. 3) Patients who previously indicate NO intubation, NO resuscitation. 4) Known hypersensitivity to any of the components of the formulations under study. 5) Pregnancy or breastfeeding.

Design outcomes

Primary

Measure	Time frame
1) Mortality on discharge from the Hospital (Proportion of patients who die (global and by strata: serious and critical) according to their causes and treatment groups, during their stay at the CMN Siglo XXI Specialty Hospital). Measurement time: during hospital stay. 2) Need for invasive mechanical ventilation (orotracheal intubation) in critically ill patients and, time (in days) from intubation to weaning in critically ill (if applicable) and critical patients. Measurement time: During the stay in the COVID-19 internment area, until ventilatory weaning.	—

Measure

Time frame

1) Mortality on discharge from the Hospital (Proportion of patients who die (global and by strata: serious and critical) according to their causes and treatment groups, during their stay at the CMN Siglo XXI Specialty Hospital). Measurement time: during hospital stay. 2) Need for invasive mechanical ventilation (orotracheal intubation) in critically ill patients and, time (in days) from intubation to weaning in critically ill (if applicable) and critical patients. Measurement time: During the stay in the COVID-19 internment area, until ventilatory weaning.

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Secondary

Measure	Time frame
1) Reduction in the deterioration of lung function (Proportion of patients who did not require an increase in FiO2 to keep SO2 stable and without the need for intubation and / or Percentage of patients who decreased positive pressure values ??at the end of expiration [PEEP] ). Measurement time: On the 7th day after starting the treatment. 2) Need and time (in days) of non-invasive mechanical ventilation and/or oxygen therapy. Measurement time: During the stay in the COVID-19 internment area. 3) Measurement of hyperinflammation score parameters (temperature, visceromegaly, cytopenias, triglycerides, aspartate aminotransferase - TGO, fibrinogen, ferritin, D-dimer). Measurement time: at the beginning, at 72 hours and on the 7th day after starting the treatment. 4) Stay (days) in the COVID-19 internment area and global hospita (Time from the inclusion in the trial, in the COVID-19 internment area, until discharge from said area, as well as the global time of stay in the hospital (from admission to discharge)). Measurement time: during the stay in the COVID-19 internment area and hospital in general. 5) Sequential organ failure evaluation (SOFA score). Measurement time: daily, during the stay in the COVID-19 internment area. 6) Immunological evaluation through the determination of pro and anti-inflammatory cytokines and chemokines (IL-2, IL-4, IL-6, IL-10, IL-17, TNF, IFN alpha, IFN gamma, CXCL8, CCL5, CXCL9 , CCL2, CXCL10) through multiple bead-based immunoassays, with quantification of Th1, Th2 and TH17 type cytokines, chemokines and IFN alpha in human serum. Measurement time: at the beginning, at 72 hours and on the 7th day after starting the treatment. 8) Behavior of biomarkers: absolute lymphocyte count, C-reactive protein, erythrocyte sedimentation rate, lactate dehydrogenase - LDH, etc. Measurement time: at the beginning, 72 hours and 7th day after the start of treatment. 9) Antibody titers: IgM and IgG antibody titers against the S protein of the SARS-CoV-2 virus	—

Measure

Time frame

1) Reduction in the deterioration of lung function (Proportion of patients who did not require an increase in FiO2 to keep SO2 stable and without the need for intubation and / or Percentage of patients who decreased positive pressure values ??at the end of expiration [PEEP] ). Measurement time: On the 7th day after starting the treatment. 2) Need and time (in days) of non-invasive mechanical ventilation and/or oxygen therapy. Measurement time: During the stay in the COVID-19 internment area. 3) Measurement of hyperinflammation score parameters (temperature, visceromegaly, cytopenias, triglycerides, aspartate aminotransferase - TGO, fibrinogen, ferritin, D-dimer). Measurement time: at the beginning, at 72 hours and on the 7th day after starting the treatment. 4) Stay (days) in the COVID-19 internment area and global hospita (Time from the inclusion in the trial, in the COVID-19 internment area, until discharge from said area, as well as the global time of stay in the hospital (from admission to discharge)). Measurement time: during the stay in the COVID-19 internment area and hospital in general. 5) Sequential organ failure evaluation (SOFA score). Measurement time: daily, during the stay in the COVID-19 internment area. 6) Immunological evaluation through the determination of pro and anti-inflammatory cytokines and chemokines (IL-2, IL-4, IL-6, IL-10, IL-17, TNF, IFN alpha, IFN gamma, CXCL8, CCL5, CXCL9 , CCL2, CXCL10) through multiple bead-based immunoassays, with quantification of Th1, Th2 and TH17 type cytokines, chemokines and IFN alpha in human serum. Measurement time: at the beginning, at 72 hours and on the 7th day after starting the treatment. 8) Behavior of biomarkers: absolute lymphocyte count, C-reactive protein, erythrocyte sedimentation rate, lactate dehydrogenase - LDH, etc. Measurement time: at the beginning, 72 hours and 7th day after the start of treatment. 9) Antibody titers: IgM and IgG antibody titers against the S protein of the SARS-CoV-2 virus

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Countries

Mexico

Contacts

Public ContactEduardo Ferat Osorio

Health Research Division. UMAE, Specialty Hospital Siglo XXI National Medical Center, IMSS.

eduardoferat@me.com

Outcome results

None listed

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