Trial Outcomes & Findings for Nebulised Dornase Alfa for Treatment of COVID-19 (Coronavirus Disease 2019) (NCT NCT04359654)
NCT ID: NCT04359654
Last Updated: 2025-01-13
Results Overview
Analysing stabilisation of C-reactive protein.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
7 days
Results posted on
2025-01-13
Participant Flow
Recruited from acute COVID-19 (Coronavirus Disease 2019) wards between between May 2020-October 2021
Participant milestones
| Measure |
Dornase Alfa Treatment
Best available care and nebulised Dornase alfa \[2.5 mg BID (bis in die)\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure
Dornase alfa Inhalation Solution \[Pulmozyme\]: Nebulised Dornase alfa 2.5mg bd for 7 days
|
Best Available Care
Best available standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
10
|
|
Overall Study
COMPLETED
|
30
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Dornase Alfa Treatment
Best available care and nebulised Dornase alfa \[2.5 mg BID (bis in die)\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure
Dornase alfa Inhalation Solution \[Pulmozyme\]: Nebulised Dornase alfa 2.5mg bd for 7 days
|
Best Available Care
Best available standard of care
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dornase Alfa Treatment
n=30 Participants
Best available care and nebulised dornase alfa \[2.5 mg BID\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure
Dornase Alfa Inhalation Solution \[Pulmozyme\]: Nebulised Dornase alfa 2.5mg bd for 7 days
|
Best Available Care
n=9 Participants
Best available standard of care
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 12.5 • n=30 Participants
|
53.3 years
STANDARD_DEVIATION 13.7 • n=9 Participants
|
56.8 years
STANDARD_DEVIATION 13.7 • n=39 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=30 Participants
|
2 Participants
n=9 Participants
|
9 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=30 Participants
|
7 Participants
n=9 Participants
|
30 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
C-reactive protein
|
101.9 mg/L
STANDARD_DEVIATION 52.2 • n=30 Participants
|
91.9 mg/L
STANDARD_DEVIATION 68.1 • n=9 Participants
|
100.2 mg/L
STANDARD_DEVIATION 63.3 • n=39 Participants
|
|
Co-morbidities
|
14 Participants
n=30 Participants
|
6 Participants
n=9 Participants
|
20 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: The reported LS (least squares) means are antilogs of the LS means estimated on the log scale.
Analysing stabilisation of C-reactive protein.
Outcome measures
| Measure |
Dornase Alfa Treatment
n=30 Participants
Best available care and nebulised dornase alfa \[2.5 mg BID\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure
Dornase Alfa Inhalation Solution \[Pulmozyme\]: Nebulised Dornase alfa 2.5mg bd for 7 days
|
Best Available Care (Randomised)
n=9 Participants
Best available standard of care of patients randomised (9)
|
|---|---|---|
|
Measuring the Change in Inflammation
|
23.23 mg/L
Interval 17.71 to 30.46
|
34.82 mg/L
Interval 28.55 to 42.47
|
SECONDARY outcome
Timeframe: 35 daysPopulation: Patients alive at 35 days
Survival at 35 days (28 days post last treatment day) Participants were followed up until discharge or death or a maximum of 28 days post last treatment day.
Outcome measures
| Measure |
Dornase Alfa Treatment
n=30 Participants
Best available care and nebulised dornase alfa \[2.5 mg BID\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure
Dornase Alfa Inhalation Solution \[Pulmozyme\]: Nebulised Dornase alfa 2.5mg bd for 7 days
|
Best Available Care (Randomised)
n=9 Participants
Best available standard of care of patients randomised (9)
|
|---|---|---|
|
Survival at 35 Days
|
29 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Before 35 daysNumber of participants discharged before 35 days
Outcome measures
| Measure |
Dornase Alfa Treatment
n=30 Participants
Best available care and nebulised dornase alfa \[2.5 mg BID\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure
Dornase Alfa Inhalation Solution \[Pulmozyme\]: Nebulised Dornase alfa 2.5mg bd for 7 days
|
Best Available Care (Randomised)
n=9 Participants
Best available standard of care of patients randomised (9)
|
|---|---|---|
|
Discharge Before 35 Days
|
27 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Those that had d-dimer measured.
Change in D-dimer (ug/L) The reported LS means are antilogs of the LS means estimated on the log scale.
Outcome measures
| Measure |
Dornase Alfa Treatment
n=28 Participants
Best available care and nebulised dornase alfa \[2.5 mg BID\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure
Dornase Alfa Inhalation Solution \[Pulmozyme\]: Nebulised Dornase alfa 2.5mg bd for 7 days
|
Best Available Care (Randomised)
n=9 Participants
Best available standard of care of patients randomised (9)
|
|---|---|---|
|
D-dimer (ug/L)
|
570.78 (ug/L) FEU
Interval 384.51 to 847.3
|
1656.96 (ug/L) FEU
Interval 876.93 to 3130.81
|
SECONDARY outcome
Timeframe: 7 daysPopulation: The reported LS means are antilogs of the LS means estimated on the log scale.
measure of Lymphocyte count (×109/L)
Outcome measures
| Measure |
Dornase Alfa Treatment
n=30 Participants
Best available care and nebulised dornase alfa \[2.5 mg BID\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure
Dornase Alfa Inhalation Solution \[Pulmozyme\]: Nebulised Dornase alfa 2.5mg bd for 7 days
|
Best Available Care (Randomised)
n=9 Participants
Best available standard of care of patients randomised (9)
|
|---|---|---|
|
Lymphocyte Count (×109/L)
|
1.08 ×10^9 cells/L
Interval 0.92 to 1.27
|
0.87 ×10^9 cells/L
Interval 0.76 to 0.98
|
Adverse Events
Dornase Alfa Treatment
Serious events: 8 serious events
Other events: 16 other events
Deaths: 1 deaths
Best Available Care
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dornase Alfa Treatment
n=30 participants at risk
Best available care and nebulised dornase alfa \[2.5 mg BID\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure
Dornase Alfa Inhalation Solution \[Pulmozyme\]: Nebulised Dornase alfa 2.5mg bd for 7 days
Note: Adverse events for matched historic controls were not recorded.
Participants were followed up until discharge or death or a maximum of 28 days post last treatment day.
|
Best Available Care
n=9 participants at risk
Best available standard of care Note: Adverse events for matched historic controls were not recorded. Participants were followed up until discharge or death or a maximum of 28 days post last treatment day.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/30 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.7%
2/30 • Number of events 2 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure type 2
|
3.3%
1/30 • Number of events 2 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure type 1
|
13.3%
4/30 • Number of events 4 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/30 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Infections and infestations
Pyelonephritis
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Infections and infestations
Aspiration pneumonia
|
0.00%
0/30 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Infections and infestations
Hospital acquired pneumonia
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
Other adverse events
| Measure |
Dornase Alfa Treatment
n=30 participants at risk
Best available care and nebulised dornase alfa \[2.5 mg BID\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure
Dornase Alfa Inhalation Solution \[Pulmozyme\]: Nebulised Dornase alfa 2.5mg bd for 7 days
Note: Adverse events for matched historic controls were not recorded.
Participants were followed up until discharge or death or a maximum of 28 days post last treatment day.
|
Best Available Care
n=9 participants at risk
Best available standard of care Note: Adverse events for matched historic controls were not recorded. Participants were followed up until discharge or death or a maximum of 28 days post last treatment day.
|
|---|---|---|
|
General disorders
Chest pain
|
10.0%
3/30 • Number of events 3 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
General disorders
Chest tightness
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Dry nose
|
0.00%
0/30 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/30 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Sputum bloody
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Psychiatric disorders
Confusion aggravated
|
0.00%
0/30 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Psychiatric disorders
Sleep disturbance
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Investigations
Blood glucose increased
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/30 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Cardiac disorders
Bradycardia
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Cardiac disorders
Pericardial effusion
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Nervous system disorders
Cognitive impairment
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Nervous system disorders
Dizzy spells
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Nervous system disorders
Tingling feet/hands
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Gastrointestinal disorders
Blood in stool
|
0.00%
0/30 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/30 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/30 • 35 days or discharge whichever was sooner
|
11.1%
1/9 • Number of events 1 • 35 days or discharge whichever was sooner
|
|
Gastrointestinal disorders
Rectal bleeding
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Gastrointestinal disorders
Tingling mouth
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Gastrointestinal disorders
Ulcerative colitis relapse
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Hepatobiliary disorders
Transaminitis
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Musculoskeletal and connective tissue disorders
Leg spasm
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Musculoskeletal and connective tissue disorders
Polyarthralgia
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Infections and infestations
Lower respiratory tract infection
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.3%
1/30 • Number of events 1 • 35 days or discharge whichever was sooner
|
0.00%
0/9 • 35 days or discharge whichever was sooner
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place