DISmantling COvid iNduced Neutrophil ExtraCellular Traps (DISCONNECT-1)

• Status: Recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study to investigate the safety and feasibility of rhDNase1 and its impact on neutrophil extracellular traps (NETs) in COVID-19 infected patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Exactis Innovation; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Exactis Innovation; Hamilton Health Sciences Corporation; Hoffmann-La Roche; Jewish General Hospital; McGill University Health Centre/Research Institute of the McGill University Health Centre

Criteria

Inclusion criteria

1. Verbal informed consent by patient (or legal representative), done in the presence of an impartial witness. The consent is signed by the Principal Investigator (or Co-Investigator) and the impartial witness.

2. Participants who are at least 18 years of age on the day of consenting to the informed consent

3. COVID-19 (SARS-CoV2) positive test by nasopharyngeal swab

4. Admitted to the ICU in negative pressure rooms

5. Mild to severe respiratory illness (defined as requiring admission* and/or supplemental oxygen), not intubated or on mechanical ventilation at screening and enrolment.

• Admission respiratory criteria (1 of the following):

1. Dyspnea at rest or during minimal activity (sitting, talking, coughing, swallowing);

2. Respiratory rate > 22/minute;

3. PaO2 < 65mmHg or oxygen saturation < 90% or PaO2/FiO2 ratio of less than 300

4. Infiltrate on CXR (or worsening CXR, if baseline CXR at admission was already abnormal)

• Mild disease with hospitalization:

• No oxygen therapy;

• Oxygen by mask or nasal prongs.

• Severe disease with hospitalization (requiring greater than 40% oxygen):

• Oxygen by non-invasive ventilation or high flow oxygen/Optiflow.

Exclusion criteria:

1. Patients requiring mechanical ventilation at screening

2. Previous or current treatment with rhDNase1

3. Ongoing experimental treatment with other inhaled therapies through COVID-19-related clinical trials

4. Known hypersensitivity to NET inhibitor or recombinant protein products

5. Known hypersensitivity to Chinese Hamster Ovary cell products or any component of the product

6. Known history of immunodeficiency, HBV, HCV, HIV (Note: No HBV, HCV or HIV testing is required unless mandated by local health authority)

7. Known history of immunosuppressive disorders, such as primary/secondary immunodeficiencies, lymphoproliferative diseases

8. Active pregnancy at any stage or lactation

9. Patients deemed incapable and/or incompetent