Covid19
Conditions
Brief summary
Double-blind parallel trial to assess the efficacy and safety of inhaled AQ001S in the management of acute COVID-19 symptoms compared.
Detailed description
A randomized, double-blind, placebo-controlled, parallel clinical trial to determine the safety and efficacy of inhaled AQ001S in the management of acute COVID-19 symptoms in adult patients (≥ 18 years old) who are admitted to hospital due to the severity of his/her confirmed or suspected COVID-19 disease. The patient will be treated for 28 days.
Interventions
DRUGDrug, inhalation
Solution administered by inhalation
Sponsors
Aquilon Pharmaceuticals S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient admitted to hospital due to the severity of his/her confirmed or suspected COVID-19 disease. 2. Positive virus test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using real time polymerase chain reaction (nasal swab). 3. Patient with COVID-19 clinical progression scale score ≥ 4 (hospitalized; no oxygen therapy). 4. Male or female, ≥18 years of age at the time of consent. 5. Patients who have given written informed consent. 6. Reliable patients who are willing to be available for the duration of the clinical trial and willing to comply with clinical trial procedures. 7. Patients who have the ability to understand the requirements of the clinical trial. 8. Female patients of childbearing potential (women of childbearing potential, WOCBP ) should have a negative pregnancy test at Screening Visit. 9. Female patients of childbearing potential (women of childbearing potential, WOCBP1) using a highly effective method of contraception (i.e., pregnancy rate of \< 1% per year) on a stable regimen, for at least 28 days, and pursuing this contraception during the trial and for 28 days after the last administration of the study drug The highly effective methods of contraception must be one of the following: combined estrogen and progestogen hormonal contraception with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or agreement on continuous abstinence from heterosexual intercourse.
Exclusion criteria
1. Intensive care patients 2. Inability to use a nebulizer with a mouthpiece. 3. History of hypersensitivity to corticosteroid or to any of the excipients in the drug preparation. 4. Untreated oral candidiasis. 5. Evidence of symptomatic chronic or acute respiratory infection other than COVID-19 in the previous 8 weeks. 6. Proven diagnosis of Chronic Obstructive Pulmonary Disease, asthma or bronchiectasis. 7. Pulmonary malformations, tuberculosis, cystic fibrosis. 8. History or presence of severe renal (stage 4 (GFR = 15-29 mL/min)) and/or severe hepatic impairment(s) (grade 4 or above) 9. Anticipated transfer to another hospital within 72 hours. 10. Use of inhaled corticosteroid, at a strength at least equivalent to 200 µg of beclomethasone per day, within 7 days before Screening Visit. 11. Systemic corticosteroids (e.g., dexamethasone) within 28 days before Screening Visit. 12. Female patients who are breast-feeding, lactating, pregnant or intending to become pregnant. 13. Any condition, including findings in the patients' medical history or in the pre-randomization study assessments that, in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. 14. Current or previous participation in another clinical trial where the patient has received a dose of an study drug containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | During 28 days of treatment | Incidence of Treatment-Emergent Adverse Events as assessed by collection of (Serious) Adverse Events and general/local tolerability |
| WHO clinical progression scale (COVID-19 clinical progression scale) | At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5) | Change in the WHO clinical progression scale (reference: WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection, Lancet Infect Dis., Aug 2020, 20(8): e192-e197) with Uninfected as minimal value (e.g. 0) and Dead as maximal value (e.g. 10, worse outcome), ffrom baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Intensive Care Unit stay | After 28 days of treatment | Length of Intensive Care Unit stay measured over the treatment period from baseline (visit 2) to day 28 (visit 5). |
| Time to hospital readmission | After 28 days of treatment | Time to hospital readmission measured over the treatment period from baseline (visit 2) to day 28 (visit 5). |
| Length of hospital readmission | After 28 days of treatment | Length of hospital readmission measured over the treatment period from baseline (visit 2) to day 28 (visit 5). |
| Time to mechanical ventilation | After 28 days of treatment | Time to mechanical ventilation measured over the treatment period from baseline (visit 2) to day 28 (visit 5). |
| Occurrence of death | Within 60 days from hospitalisation | Occurence of death (all deaths). |
| Modified Medical Research Council Dyspnea Scale | to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5) | Change in modified Medical Research Council Dyspnea (mMRC) Scale from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5). Minimum mMRC Scale value is 0 (e.g. I only get breathless with strenuous exercise). The maximum mMRC Scale value is 4 (e.g. I am too breathless to leave the house or I am breathless when dressing, worse outcome). |
| Pulmonary function measurement: Forced Expiratory Volume in the first second (FEV1) | At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5) | Changes in FEV1 measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Pulmonary function measurement: Forced Vital Capacity (FVC) | At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5) | Changes in FVC measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Pulmonary function measurement: FEV1/FVC ratio | At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5) | Changes in FEV1/FVC ratio from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Pulmonary function measurement: Oxygen saturation (SpO2) | At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5) | Changes in SpO2 measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Pulmonary function measurement: Fraction of inspired Oxygen (FiO2) | At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5) | Changes in FiO2 measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Pulmonary function measurement: SpO2/FiO2 ratio | At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5) | Changes in and SpO2/FiO2 ratio measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Diffusion Capacity for Carbon Monoxide measurements | At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5) | Changes in the Diffusion Capacity for Carbon Monoxide (DLCO) from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Pulmonary CT Scan | After 28 days of treatment | Changes in the pulmonary CT Scan between baseline (Visit 2) and Day 28±2 (Visit 5) |
| Time to hospital discharge | After 28 days of treatment | Time to hospital ldischarge measured over the treatment period from baseline (visit 2) to day 28 (visit 5). |
| Time to Intensive Care Unit admission | After 28 days of treatment | Time to Intensive Care Unit admission measured over the treatment period from baseline (visit 2) to day 28 (visit 5). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in lymphocyte count | After 28 days of treatment | Changes in lymphocyte count will be measured from baseline (Visit 2) to Day 28±2 (Visit 5). |
| Change in hyperinflammation biomarker: ferritin | After 28 days of treatment | Changes in hyperinflammation biomarkers will be measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Change in hyperinflammation biomarker: C reactive protein | After 28 days of treatment | Changes in hyperinflammation biomarkers will be measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Change in hyperinflammation biomarker: d-dimer | After 28 days of treatment | Changes in hyperinflammation biomarkers will be measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Change in hyperinflammation biomarker: soluble cluster of differentiation 40 ligand | After 28 days of treatment | Changes in hyperinflammation biomarkers will be measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Change in hyperinflammation biomarker: matrix metalloproteinase | After 28 days of treatment | Changes in hyperinflammation biomarkers will be measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Change in cardiovascular biomarker: troponin | After 28 days of treatment | Changes in troponin level will be measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Change in cardiovascular biomarker: creatine kinase | After 28 days of treatment | Changes increatine kinase level will be measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2. |
| Immunology parameters: immunoglobulin A | After 28 days of treatment | Changes in immunoglobulin A rates from baseline (Visit 2) to Day 28±2 (Visit 5), and at each visit over the dosing period |
| Immunology parameters: immunoglobulin G | After 28 days of treatment | Changes in immunoglobulin G rates from baseline (Visit 2) to Day 28±2 (Visit 5), and at each visit over the dosing period |
| Change immune system response | After 28 days of treatment | Changes in the immune system response will be measured from baseline (Visit 2) to Day 28±2 (Visit 5), using a 15-plex Human Cytokine Panel assay. |
| Change in monocyte count | After 28 days of treatment | Changes in monocyte count will be measured from baseline (Visit 2) to Day 28±2 (Visit 5). |
| Immunology parameters: immunoglobulin E | After 28 days of treatment | Changes in immunoglobulin E rates from baseline (Visit 2) to Day 28±2 (Visit 5), and at each visit over the dosing period |
Countries
Belgium
Outcome results
None listed