Dornase Alpha for the Treatment of COVID-19
Determination of Dornase Alpha Effectiveness in COVID-19 Treatment
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started May 2020
Shorter than P25 for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2020
CompletedFirst Submitted
Initial submission to the registry
June 15, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2020
CompletedJune 16, 2020
May 1, 2020
3 months
June 15, 2020
June 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response
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 Outcomes (1)
Survival
3 months
Study Arms (2)
Newly Diagnosed Patient Group (n=30)
EXPERIMENTALI. Dornase Alpha treated group (n=15) ii. Control group (n=15)
Patient Group Monitored by Mechanical Ventilation (n=30)
EXPERIMENTALI. Dornase Alpha treated group (n=15) ii. Control group (n=15)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant and / or breastfeeding women.
- Any known allergy to Dornase Alpha
- Being involved in another drug study
- Previously diagnosed with chronic lung disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Acıbadem Altunizade Hospital
Istanbul, 34662, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ercument Ovalı, MD
Acıbadem Labcell Cellular Therapy Laboratories
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2020
First Posted
June 16, 2020
Study Start
May 25, 2020
Primary Completion
August 25, 2020
Study Completion
September 25, 2020
Last Updated
June 16, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share