Respiratory illness caused by Covid-19
Conditions
Interventions
Trade Name: Pulmozyme
Product Name: Pulmozyme
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Dornase Alpha
CAS Number: 143831-71-4
Concentration unit: mg/ml milligram(s)/millilitre
Conce
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female participants, aged = 18 years 2. Participants who are hospitalised for suspected Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or radiological confirmation 3. Participants with stable oxygen saturation (>=94%) on supplementary oxygen 4. CRP >= 30 mg/L 5. Participants will have given their written informed consent to participate in the study and are able to comply with instructions and nebuliser Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Females who are pregnant, planning pregnancy or breastfeeding 2. Concurrent and/or recent involvement in other research or use of another experimental investigational medicinal product that is likely to interfere with the study medication within the last 3 months before study enrolment 3. Serious condition meeting one of the following: I. respiratory distress with respiratory rate >=40 breaths/min II. oxygen saturation <=93% on high-flow oxygen 4. Require mechanical invasive or non-invasive ventilation at screening 5. Concurrent respiratory disease such as asthma, COPD and/or ILD 6. Any major disorder that in the opinion of the Investigator would interfere with the evaluation of the results or constitute a health risk for the study participant 7. Terminal disease and life expectancy <12 months without COVID-19 8. Known allergies to the dornase alpha and excipients 9. Participants who are unable to inhale or exhale orally throughout the entire nebulisation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the effect of nebulised dornase alpha on C-reactive Protein (CRP) in hospitalised participants with COVID-19;Secondary Objective: to assess the effect of nebulised dornase alpha on clinical responses in hospitalised participants with COVID-19 ;Primary end point(s): The primary endpoint is the change from baseline in acute phase reactant (C-Reactive Protein (CRP)). This is a blood test that will be measured on day 0,1,3,5,7, and at study end. This endpoint is on a continuous scale. ;Timepoint(s) of evaluation of this end point: Day 0,1,3,5,7, and at study end. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objective: to assess the effect of nebulised dornase alpha on clinical responses in hospitalised participants with COVID-19 Secondary endpoints may include but are not limited to: -Whole blood count and differential count -ProCalcitonin (PCT) -D-Dimer -Oxygen requirement (oxygen flow or oxygenation index) -Length of ICU stay [hours] -Length of stay in the hospital [days] -Incidence of multi-organ failure according to SOFA (Sepsis-related Organ Failure Assessment) -Incidence of Ventilator-Associated Pneumonia (VAP) or hospital acquired pneumonia -Acute physiology score + age points + chronic health points (APACHE score) -Ordinal score (WHO scoring tool);Timepoint(s) of evaluation of this end point: Blood samples are taken on Day1, Day3, Day5 and Day7. Other timepoints for evaluation are indicated in secondary timepoint | — |
Countries
United Kingdom
Outcome results
None listed