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

Study Design
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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

Drug Information available for: Dornase alfa

U.S. FDA Resources

Arms and Interventions

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Arm Intervention/treatment
Drug: Pulmozyme
Experimental: Newly Diagnosed Patient Group (n=30) PULMOZYME contains an active substance
I. Dornase Alpha treated group (n=15) called dornase alpha as an active substance.
ii. Control group (n=15) 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) Drug: Pulmozyme

I. Dornase Alpha treated group (n=15) PULMOZYME contains an active substance
called dornase alpha as an active substance.
ii. Control group (n=15)
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
Outcome Measures
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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

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members
or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the
study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

https://clinicaltrials.gov/ct2/show/study/NCT04432987?cond=COVID-19&draw=3&rank=10

Responsible Party: Acibadem University

ClinicalTrials.gov Identifier: NCT04432987 History of Changes
Other Study ID Numbers: 8820
First Posted: June 16, 2020 Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: May 2020
ercument.ovali@acibademlabcell.com.tr