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Dornase Alpha for the Treatment of 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: NCT04432987
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
The Scientific and Technological Research Council of Turkey
Information provided by (Responsible Party):
Acibadem University

Brief Summary:
In this study, the effectiveness of the Dornase Alpha treatment, which is known to reduce the viscosity of respiratory secretions, will be investigated in new diagnosed and severe COVID-19 patients separately.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Pulmozyme Phase 2

Detailed Description:

Recent studies confirmed the role of immune hyperactivation in the pathogenesis of COVID-19. Immune cells, especially neutrophils, infiltrate pulmonary capillaries that cause acute fibrin deposition and extravasation into the alveolar space. This excessive accumulation of neutrophils constitutes NETs which makes the mucus thick and viscous. The highly viscous mucus lowers the patient's respiratory function and impairs ventilation supporting NETs may play a major role in the disease. As a mechanism, double-stranded DNA constitutes the backbone of NETs and Dornase alfa promotes the clearance of NETs from plasma neutralization. Endogenous Deoxyribonucleases (DNases), which physiologically break up this extracellular DNA, may become overwhelmed by a massive influx of NETs. Clinically, recombinant human DNase I (rhDNase, Dornase Alfa) has the identical primary amino acid sequence with the native human enzyme and has been approved for the management of cystic fibrosis. Daily administration of dornase alfa is effective in the treatment of cystic fibrosis patients improving pulmonary functions. The similarity of mucus secretions in COVID-19 and cystic fibrosis patients by the means of NETs makes Dornase alfa as a therapeutic option in COVID-19.

Progressive COVID-19 pneumonia may be mortal if it is not treated early, causing respiratory failure. The most important factor leading to respiratory failure is hyaline membrane formed by a neutrophil trap that develops in the cavities of the alveoli. Dornase Alpha is thought to have an important contribution by the lysis of this hyalen membrane. In this study, it is aimed to evaluate the effectiveness of Dornase Alpha treatment in case of early and late use in COVID-19 disease.

Patients diagnosed with COVID-19 PCR and / or radiological-clinical findings is included in the study, and this treatment is carried out in 2 patient groups in comparison with the control groups. The groups are:

  1. Newly Diagnosed Patient Group I. Dornase Alpha treated group ii. Control group
  2. Patient Group Monitored by Mechanical Ventilation I. Dornase Alpha treated group ii. Control group

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determination of Dornase Alpha Effectiveness in COVID-19 Treatment
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : August 25, 2020
Estimated Study Completion Date : September 25, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Newly Diagnosed Patient Group (n=30)

I. Dornase Alpha treated group (n=15)

ii. Control group (n=15)

Drug: Pulmozyme

PULMOZYME contains an active substance called dornase alpha as an active substance. Dornase alpha is a human-made version of a protein called DNase in your body and is also known as recombinant human deoxyribonuclease 1 or rhDNase.

Drug will be administered at a dose of 2,5 mg/2 times per day for 7 days


Experimental: Patient Group Monitored by Mechanical Ventilation (n=30)

I. Dornase Alpha treated group (n=15)

ii. Control group (n=15)

Drug: Pulmozyme

PULMOZYME contains an active substance called dornase alpha as an active substance. Dornase alpha is a human-made version of a protein called DNase in your body and is also known as recombinant human deoxyribonuclease 1 or rhDNase.

Drug will be administered at a dose of 2,5 mg/2 times per day for 7 days





Primary Outcome Measures :
  1. Response [ Time Frame: 3 months ]

    i. The patient has no complaints (cough and dyspnea completely disappear, the number of breaths are in the age-appropriate range, oxygen saturation is in the normal range), inflammatory markers in blood improve (CRP, LDH, Ferritin and D-Dimer regression to the reference range).

    ii. Extubation (for mechanically ventilated group)

    iii. Intubated (for newly diagnosed group)



Secondary Outcome Measures :
  1. Survival [ Time Frame: 3 months ]
    Death



Information from the National Library of Medicine

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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:

  • Being 18 or older
  • Approving the Informed Consent Form
  • Being diagnosed with COVID-19 with PCR and / or radiological clinical findings
  • Hospitalization indication according to Ministry of Health criteria

Exclusion Criteria:

  • Pregnant and / or breastfeeding women.
  • Any known allergy to Dornase Alpha
  • Being involved in another drug study
  • Previously diagnosed with chronic lung disease

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): NCT04432987


Contacts
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Contact: Ercument Ovalı, MD +905325729174 ercument.ovali@acibadem.com

Locations
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Turkey
Acıbadem Altunizade Hospital Recruiting
Istanbul, Turkey, 34662
Contact: Ercument Ovalı, Prof.    +905325729174    ercument.ovali@acibademlabcell.com.tr   
Sponsors and Collaborators
Acibadem University
The Scientific and Technological Research Council of Turkey
Investigators
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Principal Investigator: Ercument Ovalı, MD Acıbadem Labcell Cellular Therapy Laboratories
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Responsible Party: Acibadem University
ClinicalTrials.gov Identifier: NCT04432987    
Other Study ID Numbers: 8820
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Acibadem University:
COVID-19, Dornase Alpha