COVID-19 related respiratory disease MedDRA version: 23.0 Level: LLT Classification code 10084270 Term: SARS-CoV-2 acute respiratory disease System Organ Class: 100000004862
Conditions
Sponsors
Aquilon Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
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 SARS-CoV-2 using RT-PCR (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, WOCBP) using a highly effective method of contraception (i.e., pregnancy rate of =65 years) yes F.1.3.1 Number of subjects for this age range 49
Exclusion criteria
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 asthma or bronchiectasis. 7. Proven diagnosis of COPD treated with ongoing ICS and/or corticosteroid treatment within 3 months prior to randomization. 8. Pulmonary malformations, tuberculosis, cystic fibrosis. 9. History or presence of severe hepatic impairment (i.e. alanine transaminase (ALT) and aspartate transaminase (AST) greater than 15 times the upper limit of normal) 10. History or presence of severe renal impairment (considered as clinically significant according to the investigator’s discretion (i.e., stage 4 (DFR=15-29 mL/min)). 11. Anticipated transfer to another hospital within 72 hours. 12. Use of ICS, at a strength at least equivalent to 200 µg of beclomethasone per day, within 7 days before Screening Visit. 13. Female patients who are breast-feeding, lactating, pregnant or intending to become pregnant. 14. 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. 15. Current or previous participation in another clinical trial where the patient has received a dose of an IMP 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 |
|---|---|
| Main Objective: To assess the safety of AQ001S in the management of acute COVID-19 symptoms To assess the efficacy of AQ001S in the management of acute COVID-19 symptoms To assess the effects of AQ001S on pharmacodynamic (PD) parameters related to COVID-19 ;Secondary Objective: Not applicable;Primary end point(s): The safety will be evaluated collecting the following information: • Adverse events and serious adverse events • General tolerability: vital signs, ECG, physical examination (including signs of hypercorticism and adrenal suppression) • Laboratory parameters: hematology, biochemistry and urinalysis • Safety and tolerability - respiratory rate • Safety and tolerability - oxygen saturation • Local tolerability: o Increased bronchial irritability o Paradoxical bronchospasm o Oropharyngeal examination (e.g. vocal cord myopathy, fungal infection) The efficacy will be evaluated collecting the following information: • Change in the COVID-19 clinical progression scale from baseline (Visit 2) to Day 7±2, Day 14±2, Day 28±2. • changes in COVID-19 clinical endpoints from baseline (Visit 2) to Day 28 ±2 (Visit 5): o Time to discharge, o Time to ICU admission, o Length of ICU stay, o Time to hospital readmission. o Length of hospital readmission o Time to mechanical ventilation o Occurrence of death within 60 days • Change in mMRC (Modified Medical Research Council) Dyspnea Scale from baseline (Visit 2) at Day 28±2 • Changes in the pulmonary function (Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, SpO2, FiO2 and SpO2/FiO2 ratio) from baseline (Visit 2) to Day 28±2 • Changes in the diffusion capacity for carbon monoxide (DLCO) from baseline (Visit 2) to Day 28±2 • Changes in the pulmonary CT Scan from baseline (Visit 2) to Day 28±2 The PD will be evaluated collecting the following information: • Changes in the systemic inflammatory and cardiovascular biomarkers from baseline (Visit 2) to Day 7±2, | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Assesssment of 6-minute walking test (6MWT) results at Day 28±2 • Changes in nocturnal oximetry from baseline (Visit 2) to Day 28±2 • Changes in Saint-Georges’ questionnaire from baseline (Visit 2) to Day 28±2 • Change in VAS chest pain from baseline (Visit 2) to Day 7±2, Day 14±2, Day 28±2 • Changes in ACQ-5 quality of life questionnaire from baseline (Visit 2) to Day 7±2, Day 14±2, Day 28±2. • Measurement of the level of circulating exosomes in blood at baseline (Visit 2) and Day 7±2, Day 14±2, Day 28±2. ;Timepoint(s) of evaluation of this end point: At visits 2 (Baseline), 3 (Week 1), 4 (Week 2) and 5 (Day 28). See Endpoint description for more information. | — |
Countries
Belgium
Contacts
Public ContactClinical Operations
Aquilon Pharmaceuticals
Outcome results
None listed