Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19

COVID-19 Clinical Trial

Official title:

Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19 - a Phase 2, Single-blinded, Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541979
• Other study ID #: NETSC-19
• Status: Recruiting
• Phase: Phase 2
• Start date: June 4, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Region Skane
• Contact: Adam Linder, MD
• Phone: 004646171130
• Email: adam.linder[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recent observations have suggested a role of neutrophil extracellular traps (NETs) in the pathophysiology of severe COVID-19. The aim of the study is to assess efficacy and safety of aerosolized DNase I to remove NETs and decrease respiratory distress in patients with COVID-19.

Description:

Study objectives: Primary objective: To compare the treatment effect of aerosolized DNase I to that of placebo (NaCl, 0.9%) on time to cessation of oxygen therapy or discharge from hospital in hospitalized patients with COVID-19 and respiratory dysfunction.

Secondary objectives: To compare the treatment effect of aerosolized DNase I to that of placebo (NaCl, 0.9%) on 28-day mortality, days alive and without ventilator treatment, days alive and without high flow nasal oxygen treatment (Optiflow), length of stay in the ICU, days alive and outside hospital, relapse of hypoxia, days alive and without need for supplemental oxygen, adverse reactions.

Exploratory objectives: To compare the treatment effect of aerosolized DNase I to that of placebo (NaCl, 9%) on quantification of NETs in respiratory secretions and on the incidence of clinical thromboembolic events.

Study design: Phase 2 open-label randomized controlled multicentre trial. The study period is 28 days from randomization. A long term follow-up on mortality and readmission will also be collected via patient medical records/registries at day 90, day 180, and day 360 after randomization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years old

• Admitted to hospital ward or ICU

• A positive PCR test for SARS-CoV-2 from throat swab or nasopharynx

• An oxygen saturation =90% after maximum 15 minutes without supplemental oxygen

• Signed informed consent

Exclusion Criteria:

• Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation

• Known or suspected allergy against Pulmozyme

• Chronic obstructive pulmonary disease stage III-IV or another comparable chronic respiratory disease

• Participation in a clinical study with an investigational product during the last 30 days

• Previous participation in this study

• Pregnancy. Women of childbearing potential must agree to use contraceptives for the duration of the study period

• Any condition that, in the opinion of the Investigator, would place the patient at increased risk or preclude the patient's compliance with the study

Related Conditions & MeSH terms

• COVID-19
• Respiratory Insufficiency

Intervention

Drug:
• aerosolized DNase
DNase
• NaCl
NaCl 0.9%, isotonic saline

Locations

Country	Name	City	State
Sweden	Lund ED	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to cessation of oxygen therapy DNase I to that of placebo (NaCl, 0.9%) on time to cessation of oxygen therapy hospitalized patients with COVID-19 and respiratory dysfunction.	Number of Days to cessation of oxygen therapy after start of treatment	28 days
Secondary	28-day mortality	Number of diseased patients up to 28 Days after start of treatment	28 days
Secondary	Number of Days alive and without ventilator treatment	Number of Days alive and without ventilator treatment up to 28 Days after start of treatment	28 days
Secondary	Number of Days alive and without high flow nasal oxygen treatment (Optiflow)	Number of Days alive and without high flow nasal oxygen treatment (Optiflow) up to 28 Days after start of treatment	28 days
Secondary	Number of Days alive and free of stay in the ICU	Number of Days alive and free of stay in the ICU up to 28 Days after start of treatment	28 days
Secondary	Number of Days alive and outside hospital	Number of Days alive and outside hospital up to 28 Days after start of treatment	28 days
Secondary	Number of Days alive and free of a new episode and with oxygen saturation =93% after primary endpoint has been met	Number of Days alive and free of a new episode and with oxygen saturation =93% after primary endpoint has been met up to 28 Days after start of treatment	28 days
Secondary	Number of Days alive and without need of supplemental oxygen	Number of Days alive and without need of supplemental oxygen up to 28 Days after start of treatment	28 days
Secondary	Number of patients with adverse reactions	Number of patients with adverse reactions reported up to 28 Days after start of treatment	28 days