Double-blind parallel trial to assess the efficacy and safety of inhaled AQ001S in the management of acute COVID-19 symptoms compared.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
Solution administered by inhalation
CHU Liege
Liège, Belgium
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events as assessed by collection of (Serious) Adverse Events and general/local tolerability
Time frame: During 28 days of treatment
WHO clinical progression scale (COVID-19 clinical progression scale)
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.
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Time to hospital discharge
Time to hospital ldischarge measured over the treatment period from baseline (visit 2) to day 28 (visit 5).
Time frame: After 28 days of treatment
Time to Intensive Care Unit admission
Time to Intensive Care Unit admission measured over the treatment period from baseline (visit 2) to day 28 (visit 5).
Time frame: After 28 days of treatment
Length of Intensive Care Unit stay
Length of Intensive Care Unit stay measured over the treatment period from baseline (visit 2) to day 28 (visit 5).
Time frame: After 28 days of treatment
Time to hospital readmission
Time to hospital readmission measured over the treatment period from baseline (visit 2) to day 28 (visit 5).
Time frame: After 28 days of treatment
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Length of hospital readmission
Length of hospital readmission measured over the treatment period from baseline (visit 2) to day 28 (visit 5).
Time frame: After 28 days of treatment
Time to mechanical ventilation
Time to mechanical ventilation measured over the treatment period from baseline (visit 2) to day 28 (visit 5).
Time frame: After 28 days of treatment
Occurrence of death
Occurence of death (all deaths).
Time frame: Within 60 days from hospitalisation
Modified Medical Research Council Dyspnea Scale
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).
Time frame: to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: Forced Expiratory Volume in the first second (FEV1)
Changes in FEV1 measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2.
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: Forced Vital Capacity (FVC)
Changes in FVC measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2.
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: FEV1/FVC ratio
Changes in FEV1/FVC ratio from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2.
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: Oxygen saturation (SpO2)
Changes in SpO2 measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2.
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: Fraction of inspired Oxygen (FiO2)
Changes in FiO2 measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2.
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: SpO2/FiO2 ratio
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.
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Diffusion Capacity for Carbon Monoxide measurements
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.
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary CT Scan
Changes in the pulmonary CT Scan between baseline (Visit 2) and Day 28±2 (Visit 5)
Time frame: After 28 days of treatment