Efficacy and Safety Study of Nangibotide in Patients With COVID-19 Receiving Ventilatory Support and Features of Systemic Inflammation.

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, in which one dose of nangibotide will be tested versus placebo.

All patients with a diagnosis of COVID-19, and a requirement for respiratory support will be considered for study participation. The applicable local requirements for informed consent will be followed. Where permissible, an emergency consent procedure will be followed for patients unable to provide consent by themselves. All potential study patients will receive standard of care treatment throughout the study. Patients will receive a continuous intravenous (i.v.) infusion of nangibotide at 1.0 mg/kg/h or a matching placebo. Treatment with study drug must be initiated as early as possible but no later than 48 hours after the initiation of ventilatory support (Patients will be treated for 5 days or until discharge from critical care, whichever is sooner). Follow-up visits will be performed on days 8 and

14. The end of study visit is at day 28. A further follow up visit will be undertaken on day 60.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inotrem
• Treatments: Nangibotide

Criteria

Inclusion Criteria:

1. Provided 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

5. A PaO2:FiO2 ratio of <200mmHg (<26.7kPa) with a FiO2 ≥0.6

6. Confirmed laboratory diagnosis of COVID-19 within 7 days of meeting screening criteria

Exclusion Criteria:

1. Known pregnancy (positive urine or serum pregnancy test)

2. Currently receiving an immunomodulatory agent for the treatment of COVID-19 (including participation in clinical trials of such agents where treatment allocation is blinded or allocated on an open label basis).

3. Body mass index (BMI) ≥ 40 kg/m2or 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

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