CIMMCov: A randomized clinical study for prevention of severe disease in mild-to-moderate COVID-19 patients, using the inhaled medication Ciclesonide.

The CIMMCov-study: A Single-center, Double-blinded, Randomized, 28-days, Parallel-group, study to evaluate the effect of Ciclesonide 320 mcg inhalation twice daily versus placebo on healthcare utilization, disease progression and symptoms in the treatment of mild-to-moderate COVID-19. - CIMMCov

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002208-37-DK

Enrollment

138

Registered

2020-06-08

Start date

2021-04-29

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 pneumonia MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862

Interventions

Trade Name: Alvesco Product Name: Alvesco Product Code: 081801 Pharmaceutical Form: Inhalation vapour, liquid INN or Proposed INN: CICLESONIDE CAS Number: 141845-82-1 Concentration unit: µg microgram(

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 69 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 69

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: Not applicable;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. ;Timepoint(s) of evaluation of this end point: 28 days	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: Not applicable;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. ;Timepoint(s) of evaluation of this end point: 28 days

—

Secondary

Measure	Time frame
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) ;Timepoint(s) of evaluation of this end point: As assigned in E.5.2.	—

Measure

Time frame

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) ;Timepoint(s) of evaluation of this end point: As assigned in E.5.2.

—

Countries

Denmark

Contacts

Public ContactCharlotte Suppli Ulrik

Respiratory Reseach Unit 237, Hvidovre Hospital

charlotte.suppli.ulrik@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026