A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EB05 + standard of care versus placebo + standard of care in adult hospitalized patients with COVID19

A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EB05 + SOC vs. placebo + SOC in adult hospitalized patients with COVID19

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-006044-14-PL

Enrollment

1501

Registered

2021-03-26

Start date

2021-10-25

Completion date

Unknown

Last updated

2022-03-02

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

Conditions

SARS-CoV-2 Positive Pneumonia - level 3-7 in the nine-point COVID-19 severity scale: MedDRA version: 23.1 Level: PT Classification code 10084380 Term: COVID-19 pneumonia System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.1 Level: LLT Classification code 10084383 Term: Novel COVID-19-infected pneumonia System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: EB05 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: There is no recommended International Non-proprietary Name Other descriptive name: NI-0101 Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main Study: All the following criteria need to be met for inclusion: 1. Men and women =18 years of age at the time of consent. 2. Laboratory-confirmed diagnosis of COVID-19. 3. Hospitalized for COVID-19 related respiratory disease. 4. Patient belongs to one of the following four categories in the nine-point COVID-19 severity scale: • Hospitalized, not requiring supplemental oxygen –Level 3 of the nine-point COVID-19 severity scale. • Hospitalized, requiring supplemental oxygen – Level 4 of the nine-point COVID-19 severity scale. • Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both – Level 5 of the nine-point COVID-19 severity scale. • Hospitalized, requiring intubation and mechanical ventilation- Level 6 of the nine-point COVID-19 severity scale. 5. For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during the study period. 6. Informed consent obtained from any patient capable of giving consent, or, when the patient is not capable of giving consent, from his or her legal/authorized representatives. Sub (Exploratory) Study: • All the inclusion criteria of the Main Study with the following substitution for inclusion criterion (4): • Hospitalized, requiring ventilation for more than 5 days or intubation + additional organ support – pressors, RRT, ECMO - Level 7 of the nine-point COVID-19 severity scale. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 975 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 526

Exclusion criteria

Exclusion criteria: Patients will be excluded if any of the following criteria are met: 1. The subject is a female who is breastfeeding or pregnant. 2. Known hypersensitivity to EB05 or its excipients. 3. In the opinion of the investigator, death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. 4. Active participation in other immunomodulator or immunosuppressant drug clinical trials. • participation in COVID-19 antiviral, anticoagulant and convalescent plasma trials may be permitted; however, the decision to enroll a patient who is participating in other clinical trials will be dealt with on a case by case basis. 5. Treatment with immunomodulator or immunosuppressant drugs, including but not limited to IL-6 inhibitors, TNF inhibitors, antiIL-1 agents, and JAK inhibitors within 5 half-lives or 30 days (whichever is longer) before randomization. (Note treatment with immunomodulator or immunosuppressant drugs, such as corticosteroids, as part of SOC, is permitted). 6. Known other clinical conditions that contraindicate EB05 and cannot be treated or solved according to the judgement of the clinician.

Design outcomes

Primary

Measure	Time frame
Main Objective: Main Study Primary Objective To evaluate the clinical efficacy of EB05 + SOC vs. Placebo + SOC in adult hospitalized patients with mild to severe COVID-19 disease defined as WHO-COVID Severity scale score of 3 - 6. Sub (Exploratory) Study Primary Objective To evaluate the clinical efficacy of EB05 + SOC vs. Placebo + SOC in adult hospitalized patients with very severe COVID-19 disease defined as ventilation requirement for more than 5 days or WHO-COVID Severity scale score of 7.;Secondary Objective: Secondary Objective To evaluate the safety of EB05 in adult hospitalized patients with mild to severe COVID-19 disease defined as WHO-COVID Severity scale score of 3 - 6. Sub (Exploratory) Study Secondary Objective To evaluate the safety of EB05 in adult hospitalized patients with very severe COVID-19 disease defined as ventilation requirement for more than 5 days or WHO-COVID Severity scale score of 7.;Primary end point(s): Primary Efficacy Endpoint Main Study The proportion of patients that are alive and without any need for oxygen support defined as a score of 3 or less in the above scale. The primary endpoint will be assessed at 28-days after treatment initiation. Sub (Exploratory) Study The cumulative mortality rate at 60 days after treatment initiation.;Timepoint(s) of evaluation of this end point: Main Study - 28 Day Sub (Exploratory) Study - 60 Day	—

Measure

Time frame

Main Objective: Main Study Primary Objective To evaluate the clinical efficacy of EB05 + SOC vs. Placebo + SOC in adult hospitalized patients with mild to severe COVID-19 disease defined as WHO-COVID Severity scale score of 3 - 6. Sub (Exploratory) Study Primary Objective To evaluate the clinical efficacy of EB05 + SOC vs. Placebo + SOC in adult hospitalized patients with very severe COVID-19 disease defined as ventilation requirement for more than 5 days or WHO-COVID Severity scale score of 7.;Secondary Objective: Secondary Objective To evaluate the safety of EB05 in adult hospitalized patients with mild to severe COVID-19 disease defined as WHO-COVID Severity scale score of 3 - 6. Sub (Exploratory) Study Secondary Objective To evaluate the safety of EB05 in adult hospitalized patients with very severe COVID-19 disease defined as ventilation requirement for more than 5 days or WHO-COVID Severity scale score of 7.;Primary end point(s): Primary Efficacy Endpoint Main Study The proportion of patients that are alive and without any need for oxygen support defined as a score of 3 or less in the above scale. The primary endpoint will be assessed at 28-days after treatment initiation. Sub (Exploratory) Study The cumulative mortality rate at 60 days after treatment initiation.;Timepoint(s) of evaluation of this end point: Main Study - 28 Day Sub (Exploratory) Study - 60 Day

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Secondary Efficacy Endpoints Main Study and Sub (Exploratory) Study 1. Day 28 2. Day 28 3. Day 28 4. Day 28 5. Day 28 6. Day 60 7. Day 60 8. Day 60 9. Day 60 10. course of the study 11. course of the study 12. during 28 days 13. course of the study 14. Day 28. 15. course of the study 16. course of the study 17. during 28-days and 60-days 19. course of the study 20. course of the study. 21. course of the study 22. course of the study 23. course of the study 24. course of the study 25. course of the study 26. course of the study 27. course of the study 28. course of the study Sub Study 1. course of the study 2. course of the study;Secondary end point(s): Secondary Efficacy Endpoints Main Study and Sub (Exploratory) Study 1. Time to therapeutic response (primary efficacy endpoint of the Main Study). 2. The proportion of patients with clinical improvement, defined as a decrease of two points or more on the WHO 9 – point ordinal scale at Day 28. 3. The proportion of patients that are alive and discharged home without any need for oxygen support (WHO Scale of =2) at Day 28. 4. The proportion of patients that are alive and free of respiratory failure (WHO scale = 4) at Day 28. 5. The proportion of patients with clinical improvement, defined as a decrease of two points or more on the WHO 9 – point ordinal scale at Day 28. 6. The proportion of patients with clinical improvement, defined as a decrease of two points or more on the WHO 9 – point ordinal scale at Day 60. 7. The proportion of patients with clinical improvement, defined as a decrease of one point or more on the WHO 9 – point ordinal scale at Day 60. 8. The proportion of patients that are alive and discharged home without any need for oxygen support (WHO Scale of = 2) at Day 60. 9. The proportion of patients that are alive and free of respiratory failure (WHO scale = 4) at Day 60. 10. Time to clinical improvement by 2 p	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Secondary Efficacy Endpoints Main Study and Sub (Exploratory) Study 1. Day 28 2. Day 28 3. Day 28 4. Day 28 5. Day 28 6. Day 60 7. Day 60 8. Day 60 9. Day 60 10. course of the study 11. course of the study 12. during 28 days 13. course of the study 14. Day 28. 15. course of the study 16. course of the study 17. during 28-days and 60-days 19. course of the study 20. course of the study. 21. course of the study 22. course of the study 23. course of the study 24. course of the study 25. course of the study 26. course of the study 27. course of the study 28. course of the study Sub Study 1. course of the study 2. course of the study;Secondary end point(s): Secondary Efficacy Endpoints Main Study and Sub (Exploratory) Study 1. Time to therapeutic response (primary efficacy endpoint of the Main Study). 2. The proportion of patients with clinical improvement, defined as a decrease of two points or more on the WHO 9 – point ordinal scale at Day 28. 3. The proportion of patients that are alive and discharged home without any need for oxygen support (WHO Scale of =2) at Day 28. 4. The proportion of patients that are alive and free of respiratory failure (WHO scale = 4) at Day 28. 5. The proportion of patients with clinical improvement, defined as a decrease of two points or more on the WHO 9 – point ordinal scale at Day 28. 6. The proportion of patients with clinical improvement, defined as a decrease of two points or more on the WHO 9 – point ordinal scale at Day 60. 7. The proportion of patients with clinical improvement, defined as a decrease of one point or more on the WHO 9 – point ordinal scale at Day 60. 8. The proportion of patients that are alive and discharged home without any need for oxygen support (WHO Scale of = 2) at Day 60. 9. The proportion of patients that are alive and free of respiratory failure (WHO scale = 4) at Day 60. 10. Time to clinical improvement by 2 p

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Countries

Canada, Colombia, Poland, United States

Contacts

Public ContactJSS Medical Research Europe Sp. z o

JSS Medical Research Europe Sp. z o.o.

jakub.srednicki@jssresearch.com+48509942244

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026