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

Phase 1

• Conditions: Covid-19; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001504-42-FR
• Lead Sponsor: INOTREM S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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 <24 hours after blood sample collection for at least one of the following within 7 days after the initiation of mechanical ventilation:
• C Reactive Protein > 40 mg/L
OR
• Ferritin >500 µg/L
OR
• Lymphocyte count of <1.0x10e9/L

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

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