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

Exploratory study of the safety, tolerability and efficacy of nangibotide in mechanically ventilated patients with COVID-19 and features of systemic inflammation - A randomized, double-blind, placebo-controlled study with adaptive features.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001504-42-FR

Enrollment

Registered

2020-04-20

Start date

2020-07-15

Completion date

Unknown

Last updated

2020-07-20

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

Conditions

Covid-19 MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862

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. Mechanically-ventilated patient for acute respiratory distress caused by COVID-19 4. Confirmed laboratory diagnosis of COVID-19 within 7 days of meeting screening criteria 5. Laboratory markers of severity met 40 mg/L OR • Ferritin >500 µg/L OR • Lymphocyte count of =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Invasive mechanical ventilation for more than 7 days 2. Known pregnancy (positive urine or serum pregnancy test) 3. Weight > 95 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 safety and tolerability of nangibotide in mechanically ventilated patients due to Covid-19 and features of systemic inflammation;Secondary Objective: • To evaluate the effects of nangibotide exposure over 5 days in patients with Covid-19 and features of systemic inflammation • To evaluate the effect of nangibotide on clinical parameters • 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): The incidence of adverse events and mortality until day 28;Timepoint(s) of evaluation of this end point: From baseline to Day 28	—

Measure

Time frame

Main Objective: To evaluate the safety and tolerability of nangibotide in mechanically ventilated patients due to Covid-19 and features of systemic inflammation;Secondary Objective: • To evaluate the effects of nangibotide exposure over 5 days in patients with Covid-19 and features of systemic inflammation • To evaluate the effect of nangibotide on clinical parameters • 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): The incidence of adverse events and mortality until day 28;Timepoint(s) of evaluation of this end point: From baseline to Day 28

—

Secondary

Measure	Time frame
Secondary end point(s): Additional Safety Parameters • Safety laboratory tests (as part of routine clinical care): hematology, coagulation, plasma biochemistry • Adverse events (AEs), serious adverse events (SAEs) and deaths Efficacy Parameters • Clinical status defined by seven-point and ordinal scale at baseline (day 1), day 6 and 14 following initiation of treatment and day 28 • Mortality at day 28 • PaO2:FiO2 ratio • Duration and nature of mechanical ventilation • Duration and nature of other organ support therapies Pharmacodynamics (exploratory) sTREM-1, inflammatory exploratory biomarkers;Timepoint(s) of evaluation of this end point: From baseline to Day 28	—

Measure

Time frame

Secondary end point(s): Additional Safety Parameters • Safety laboratory tests (as part of routine clinical care): hematology, coagulation, plasma biochemistry • Adverse events (AEs), serious adverse events (SAEs) and deaths Efficacy Parameters • Clinical status defined by seven-point and ordinal scale at baseline (day 1), day 6 and 14 following initiation of treatment and day 28 • Mortality at day 28 • PaO2:FiO2 ratio • Duration and nature of mechanical ventilation • Duration and nature of other organ support therapies Pharmacodynamics (exploratory) sTREM-1, inflammatory exploratory biomarkers;Timepoint(s) of evaluation of this end point: From baseline to Day 28

—

Countries

Belgium, France, 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