Dornase Alpha for the Treatment of COVID-19

NCT ID: NCT04432987

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-25
• Study Completion Date: 2020-09-25

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.

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

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Newly Diagnosed Patient Group (n=30)

I. Dornase Alpha treated group (n=15)

ii. Control group (n=15)

Group Type: EXPERIMENTAL

Pulmozyme

Intervention Type: DRUG

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

Patient Group Monitored by Mechanical Ventilation (n=30)

I. Dornase Alpha treated group (n=15)

ii. Control group (n=15)

Group Type: EXPERIMENTAL

Pulmozyme

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Acibadem University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ercument Ovalı, MD

Role: PRINCIPAL_INVESTIGATOR

Acıbadem Labcell Cellular Therapy Laboratories

Locations

Acıbadem Altunizade Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ercument Ovalı, MD

Role: CONTACT

ercument.ovali@acibadem.com

+905325729174

Facility Contacts

Ercument Ovalı, Prof.

Role: primary

ercument.ovali@acibademlabcell.com.tr

+905325729174

Other Identifiers

8820

Identifier Type: -

Identifier Source: org_study_id