Clinical trial NCT05000346: Clinical Trial to Assess the Efficacy and Safety of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel, Trial to Determine the Safety and Efficacy of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: Aquilon Pharmaceuticals S.A.
Sponsor class: INDUSTRY
First posted: 2021-08-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: During 28 days of treatment
measure: WHO clinical progression scale (COVID-19 clinical progression scale)
timeFrame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Secondary outcomes:
measure: Time to hospital discharge
timeFrame: After 28 days of treatment
measure: Time to Intensive Care Unit admission
timeFrame: After 28 days of treatment
measure: Length of Intensive Care Unit stay
timeFrame: After 28 days of treatment
measure: Time to hospital readmission
timeFrame: After 28 days of treatment
measure: Length of hospital readmission
timeFrame: After 28 days of treatment
measure: Time to mechanical ventilation
timeFrame: After 28 days of treatment
measure: Occurrence of death
timeFrame: Within 60 days from hospitalisation
measure: Modified Medical Research Council Dyspnea Scale
timeFrame: to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
measure: Pulmonary function measurement: Forced Expiratory Volume in the first second (FEV1)
timeFrame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
measure: Pulmonary function measurement: Forced Vital Capacity (FVC)
timeFrame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
measure: Pulmonary function measurement: FEV1/FVC ratio
timeFrame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
measure: Pulmonary function measurement: Oxygen saturation (SpO2)
timeFrame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
measure: Pulmonary function measurement: Fraction of inspired Oxygen (FiO2)
timeFrame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
measure: Pulmonary function measurement: SpO2/FiO2 ratio
timeFrame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
measure: Diffusion Capacity for Carbon Monoxide measurements
timeFrame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
measure: Pulmonary CT Scan
timeFrame: After 28 days of treatment
Other outcomes:
measure: Change immune system response
timeFrame: After 28 days of treatment
measure: Change in monocyte count
timeFrame: After 28 days of treatment
measure: Change in lymphocyte count
timeFrame: After 28 days of treatment
measure: Change in hyperinflammation biomarker: ferritin
timeFrame: After 28 days of treatment
measure: Change in hyperinflammation biomarker: C reactive protein
timeFrame: After 28 days of treatment
measure: Change in hyperinflammation biomarker: d-dimer
timeFrame: After 28 days of treatment
measure: Change in hyperinflammation biomarker: soluble cluster of differentiation 40 ligand
timeFrame: After 28 days of treatment
measure: Change in hyperinflammation biomarker: matrix metalloproteinase
timeFrame: After 28 days of treatment
measure: Change in cardiovascular biomarker: troponin
timeFrame: After 28 days of treatment
measure: Change in cardiovascular biomarker: creatine kinase
timeFrame: After 28 days of treatment
measure: Immunology parameters: immunoglobulin E
timeFrame: After 28 days of treatment
measure: Immunology parameters: immunoglobulin A
timeFrame: After 28 days of treatment
measure: Immunology parameters: immunoglobulin G
timeFrame: After 28 days of treatment
Locations:
city: Liege
country: Belgium
facility: CHU Liege
Study officials:
affiliation: Centre Hospitalier Universitaire de Liege
name: Julien Guiot, MD
role: PRINCIPAL_INVESTIGATOR
References: