Dornase Alpha for the Treatment of COVID-19

June 15, 2020 updated by: Acibadem University

Determination of Dornase Alpha Effectiveness in COVID-19 Treatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 3 months
Death
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Principal Investigator: Ercument Ovalı, MD, Acıbadem Labcell Cellular Therapy Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2020

Primary Completion (Anticipated)

August 25, 2020

Study Completion (Anticipated)

September 25, 2020

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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