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

Phase 1

Conditions: Covid-19
MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2020-001504-42-BE

Lead Sponsor: INOTREM S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 730

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 <200mmHg (<26.7kPa) with a FiO2 =0.6
5. Confirmed laboratory diagnosis of COVID-19 within 7 days of meeting screening criteria

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 241
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 489

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>• To evaluate the effect of nangibotide on clinical parameters <br>• To evaluate the safety and tolerability of nangibotide in patients with COVID 19 <br>• To evaluate PD relationship to TREM-1 pathway related markers <br>• 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<br>;Primary end point(s): • Part 1: The incidence of adverse events and mortality until day 28<br>• Part 2: Clinical Status (7-point Ordinal Scale) assessed at Day 28<br>• Part 3: All-Cause mortality at day 28<br>;Timepoint(s) of evaluation of this end point: From baseline to Day 28

Secondary Outcome Measures

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

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