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

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ClinicalTrials.gov Identifier: NCT04541979
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Adam Linder, Region Skane

Tracking Information
First Submitted Date  ICMJE June 5, 2020
First Posted Date  ICMJE September 9, 2020
Last Update Posted Date February 25, 2021
Actual Study Start Date  ICMJE June 4, 2020
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2020)
  • 28-day mortality [ Time Frame: 28 days ]
    Number of diseased patients up to 28 Days after start of treatment
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19
Official Title  ICMJE Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19 - a Phase 2, Single-blinded, Randomized Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: aerosolized DNase
    DNase
  • Drug: NaCl
    NaCl 0.9%, isotonic saline
Study Arms  ICMJE
  • Active Comparator: Aerosolized DNase I
    Intervention: Drug: aerosolized DNase
  • Placebo Comparator: NaCl
    Intervention: Drug: NaCl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adam Linder, MD 004646171130 adam.linder@med.lu.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04541979
Other Study ID Numbers  ICMJE NETSC-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: nn
Responsible Party Adam Linder, Region Skane
Study Sponsor  ICMJE Region Skane
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adam Linder, MD Region Skåne
PRS Account Region Skane
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP