A study evaluating the efficacy, safety and tolerability of Nangibotide in patients with Covid-19.

Efficacy and Safety Study Exploring Nangibotide Treatment in COVID-19 pAtients with ventiLatory support (The ESSENTIAL Study). A randomized, double-blind, placebo-controlled study with adaptive features.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001504-42-BE

Enrollment

730

Registered

2020-05-03

Start date

2020-06-12

Completion date

Unknown

Last updated

2022-08-08

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

Conditions

Covid-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Nangibotide Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: Nangibotide CAS Number: 2014384-91-7 Other descriptive name: LR12 Concentration unit: mg mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provide written informed consent (emergency consent according to local regulations where approved) 2. Age 18 to 75 years (inclusive) 3. Admitted to an intensive care unit 4. Treatment with High Flow Nasal Oxygen, non-invasive ventilation or invasive mechanical ventilation for acute respiratory failure caused by COVID-19 for less than 48 hours 4. A PaO2:FiO2 ratio of =65 years) yes F.1.3.1 Number of subjects for this age range 489

Exclusion criteria

Exclusion criteria: 1. Known pregnancy (positive urine or serum pregnancy test) 2. Ongoing treatment with an immunomodulatory agent not included in the standard of care for COVID-19 (including participation in clinical trials of such agents) 3. Body mass index (BMI) = 40 kg/m2 or weight = 130 kg 4. Anticipated transfer to another hospital, which is not a study site within 72 hours 5. Expected to die within 6 months of treatment due to underlying chronic disease 6. Limitations of care in place during current hospital admission

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the impact of nangibotide on the progression of disease in patients receiving ventilatory support due to Covid-19;Secondary Objective: • To evaluate the effects of nangibotide exposure over 5 days in patients with Covid-19 • To evaluate the effect of nangibotide on clinical parameters • To evaluate the safety and tolerability of nangibotide in patients with COVID 19 • To evaluate PD relationship to TREM-1 pathway related markers • To evaluate the natural history of the disease regarding the activation of the TREM-1 pathways measured by soluble TREM-1 serum concentrations over time ;Primary end point(s): • Part 1: The incidence of adverse events and mortality until day 28 • Part 2: Clinical Status (7-point Ordinal Scale) assessed at Day 28 • Part 3: All-Cause mortality at day 28 ;Timepoint(s) of evaluation of this end point: From baseline to Day 28	—

Measure

Time frame

Main Objective: To evaluate the impact of nangibotide on the progression of disease in patients receiving ventilatory support due to Covid-19;Secondary Objective: • To evaluate the effects of nangibotide exposure over 5 days in patients with Covid-19 • To evaluate the effect of nangibotide on clinical parameters • To evaluate the safety and tolerability of nangibotide in patients with COVID 19 • To evaluate PD relationship to TREM-1 pathway related markers • To evaluate the natural history of the disease regarding the activation of the TREM-1 pathways measured by soluble TREM-1 serum concentrations over time ;Primary end point(s): • Part 1: The incidence of adverse events and mortality until day 28 • Part 2: Clinical Status (7-point Ordinal Scale) assessed at Day 28 • Part 3: All-Cause mortality at day 28 ;Timepoint(s) of evaluation of this end point: From baseline to Day 28

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Secondary

Measure	Time frame
Secondary end point(s): Additional Safety Parameters • The incidence of adverse events and mortality until day 28 • Safety laboratory tests (as part of routine clinical care): hematology, coagulation, plasma biochemistry • Adverse events (AEs), serious adverse events (SAEs) and deaths • Suspected adverse drug reactions (serious and non-serious) Efficacy Parameters • Improvement of clinical status on each study day until day 14, at day 28 and at day 60 using an ordinal scale • Mortality at day 28 • PaO2:FiO2 ratio • Duration and nature of supported ventilation • Incidence of thromboembolic events • Incidence of secondary infection • Duration and nature of other organ support therapies • Functional status and mortality at day 60 Pharmacodynamics (exploratory) sTREM-1, inflammatory exploratory biomarkers;Timepoint(s) of evaluation of this end point: From baseline to Day 60	—

Measure

Time frame

Secondary end point(s): Additional Safety Parameters • The incidence of adverse events and mortality until day 28 • Safety laboratory tests (as part of routine clinical care): hematology, coagulation, plasma biochemistry • Adverse events (AEs), serious adverse events (SAEs) and deaths • Suspected adverse drug reactions (serious and non-serious) Efficacy Parameters • Improvement of clinical status on each study day until day 14, at day 28 and at day 60 using an ordinal scale • Mortality at day 28 • PaO2:FiO2 ratio • Duration and nature of supported ventilation • Incidence of thromboembolic events • Incidence of secondary infection • Duration and nature of other organ support therapies • Functional status and mortality at day 60 Pharmacodynamics (exploratory) sTREM-1, inflammatory exploratory biomarkers;Timepoint(s) of evaluation of this end point: From baseline to Day 60

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Countries

Belgium, France, Spain, United States

Contacts

Public ContactValérie Cuvier-Project Manager

INOTREM S.A.

covtrem@inotrem.com+33966 81 7900

Outcome results

None listed

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