E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Respiratory illness caused by Covid-19 |
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E.1.1.1 | Medical condition in easily understood language |
Respiratory illness caused by Covid-19 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to assess the effect of nebulised dornase alpha on C-reactive Protein (CRP) in hospitalised participants with COVID-19 |
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E.2.2 | Secondary objectives of the trial |
to assess the effect of nebulised dornase alpha on clinical responses in hospitalised participants with COVID-19 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 0,1,3,5,7, and at study end. |
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E.5.2 | 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) |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Best Available Care (BAC) arm alone |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 1 |