Status:
COMPLETED
DISmantling COvid iNduced Neutrophil ExtraCellular Traps (DISCONNECT-1)
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Hamilton Health Sciences Corporation
Hoffmann-La Roche
Conditions:
COVID-19 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
It has been reported that elevated numbers of neutrophils (PMNs) in the blood predicts poor outcomes and severity in patients with COVID-19 infections. Acute inflammation results in formation of neutr...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- Participants who are at least 18 years of age on the day of consenting to the informed consent
- COVID-19 (SARS-CoV2) positive test by nasopharyngeal swab
- Admitted to the ICU in negative pressure rooms
- 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):
- Dyspnea at rest or during minimal activity (sitting, talking, coughing, swallowing);
- Respiratory rate \> 22/minute;
- PaO2 \< 65mmHg or oxygen saturation \< 90% or PaO2/FiO2 ratio of less than 300
- 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:
- Patients requiring mechanical ventilation at screening
- Previous or current treatment with rhDNase1
- Ongoing experimental treatment with other inhaled therapies through COVID-19-related clinical trials
- Known hypersensitivity to NET inhibitor or recombinant protein products
- Known hypersensitivity to Chinese Hamster Ovary cell products or any component of the product
- Known history of immunodeficiency, HBV, HCV, HIV (Note: No HBV, HCV or HIV testing is required unless mandated by local health authority)
- Known history of immunosuppressive disorders, such as primary/secondary immunodeficiencies, lymphoproliferative diseases
- Active pregnancy at any stage or lactation
- Patients deemed incapable and/or incompetent
Exclusion
Key Trial Info
Start Date :
December 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04409925
Start Date
December 25 2020
End Date
August 1 2021
Last Update
March 17 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamilton General Hospital, Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
2
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1