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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04541979
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Adam Linder, Region Skane

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: aerosolized DNase Drug: NaCl Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19 - a Phase 2, Single-blinded, Randomized Study
Actual Study Start Date : June 4, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Aerosolized DNase I Drug: aerosolized DNase
DNase
Placebo Comparator: NaCl Drug: NaCl
NaCl 0.9%, isotonic saline


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 28 days ]
    Number of Days to cessation of oxygen therapy after start of treatment


Secondary Outcome Measures :
  1. 28-day mortality [ Time Frame: 28 days ]
    Number of diseased patients up to 28 Days after start of treatment

  2. Number of Days alive and without ventilator treatment [ Time Frame: 28 days ]
    Number of Days alive and without ventilator treatment up to 28 Days after start of treatment

  3. Number of Days alive and without high flow nasal oxygen treatment (Optiflow) [ Time Frame: 28 days ]
    Number of Days alive and without high flow nasal oxygen treatment (Optiflow) up to 28 Days after start of treatment

  4. Number of Days alive and free of stay in the ICU [ Time Frame: 28 days ]
    Number of Days alive and free of stay in the ICU up to 28 Days after start of treatment

  5. Number of Days alive and outside hospital [ Time Frame: 28 days ]
    Number of Days alive and outside hospital up to 28 Days after start of treatment

  6. Number of Days alive and free of a new episode and with oxygen saturation ≤93% after primary endpoint has been met [ Time Frame: 28 days ]
    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

  7. Number of Days alive and without need of supplemental oxygen [ Time Frame: 28 days ]
    Number of Days alive and without need of supplemental oxygen up to 28 Days after start of treatment

  8. Number of patients with adverse reactions [ Time Frame: 28 days ]
    Number of patients with adverse reactions reported up to 28 Days after start of treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541979


Contacts
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Contact: Adam Linder, MD 004646171130 adam.linder@med.lu.se

Locations
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Sweden
Lund ED Recruiting
Lund, Sweden
Contact: Adam Linder       adam.linder@med.lu.se   
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Adam Linder, MD Region Skåne
More Information
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Responsible Party: Adam Linder, senior concultant, associate professor, Region Skane
ClinicalTrials.gov Identifier: NCT04541979    
Other Study ID Numbers: NETSC-19
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: nn

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Insufficiency
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders