E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Coronavirus (COVID-19) infection in the lungs |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084401 |
E.1.2 | Term | COVID-19 respiratory infection |
E.1.2 | System Organ Class | 100000004862 |
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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 |
Investigation of the hypothesis that treatment with inhaled ciclesonide 320 mcg b.i.d. will, based on the anti-viral activity in SARS-CoV-2 and the well-known anti-inflammatory effect, reduce the risk of disease progression and additional health care contacts and reduces time until clinical recovery in patients with mild-to-moderate COVID-19. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients admitted to a COVID Emergency Department less than 24 hours due to COVID-19-like symptoms Patients previously tested positive for COVID-19 at out-of-hospital test sites, hospital-driven drive-in testing sites, via a general practitioner etc., but with no previous hospital contact or admission due to COVID-19 are eligible for inclusion. Age ≥18 years. Positive COVID-19 PCR from oro- or nasopharyngeal swab or a tracheal suction fluid sample.
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E.4 | Principal exclusion criteria |
• Treatment with ciclesonide within the last three months. Allergy to ciclesonide or other compounds in the inhalation formulation. Treatment with a potent CYP3A4 inhibitor (oral azoles, ritonavir) Pregnancy Negative urine HCG-test required in fertile women. Breast feeding Insufficient inhaler and/or spacer technique, including failure to use the supplied spacer device – investigator judged
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: • Reduction in Healthcare Resource Utilization (HRU, defined as renewed contact to GP, emergency department and/or admission to hospital) due to COVID-19-related symptoms.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Key secondary endpoints: • Time to clinical recovery • Intensive care unit admission rate • All-cause hospitalization (14 and 28 days) • COVID-specific hospitalization (14 and 28 days) • Symptom burden, measured as change in Asthma Control Questionnaire (ACQ), The COPD As-sessment Test (CAT) and St. George Respiratory Questionnaire score (SGRQ) (1, 14 and 28 days) o Note: ACQ and CAT-questionnaires will only be performed in patients with asthma and COPD, respectively. Other secondary endpoints: • Proportion of patients in mechanical ventilation during hospitalization • 14-, 28- and 90-day mortality • Safety and tolerability of the study drug (number of adverse effects, proportion of early discon-tinuation)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | 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 | Yes |
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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |