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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
Double-blind parallel trial to assess the efficacy and safety of inhaled AQ001S in the management of acute COVID-19 symptoms compared.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted to hospital due to the severity of his/her confirmed or suspected COVID-19 disease.
- •Positive virus test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using real time polymerase chain reaction (nasal swab).
- •Patient with COVID-19 clinical progression scale score ≥ 4 (hospitalized; no oxygen therapy).
- •Male or female, ≥18 years of age at the time of consent.
- •Patients who have given written informed consent.
- •Reliable patients who are willing to be available for the duration of the clinical trial and willing to comply with clinical trial procedures.
- •Patients who have the ability to understand the requirements of the clinical trial.
- •Female patients of childbearing potential (women of childbearing potential, WOCBP ) should have a negative pregnancy test at Screening Visit.
- •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.
排除标准
- •Intensive care patients
- •Inability to use a nebulizer with a mouthpiece.
- •History of hypersensitivity to corticosteroid or to any of the excipients in the drug preparation.
- •Untreated oral candidiasis.
- •Evidence of symptomatic chronic or acute respiratory infection other than COVID-19 in the previous 8 weeks.
- •Proven diagnosis of Chronic Obstructive Pulmonary Disease, asthma or bronchiectasis.
- •Pulmonary malformations, tuberculosis, cystic fibrosis.
- •History or presence of severe renal (stage 4 (GFR = 15-29 mL/min)) and/or severe hepatic impairment(s) (grade 4 or above)
- •Anticipated transfer to another hospital within 72 hours.
- •Use of inhaled corticosteroid, at a strength at least equivalent to 200 µg of beclomethasone per day, within 7 days before Screening Visit.
- •Systemic corticosteroids (e.g., dexamethasone) within 28 days before Screening Visit.
- •Female patients who are breast-feeding, lactating, pregnant or intending to become pregnant.
- •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.
- •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
研究组 & 干预措施
Experimental AQ001S 0.125 mg/mL quarter in die
AQ001S 0.125 mg/mL inhalation solution administered by inhalation 4 times a day
干预措施: Drug, inhalation (Drug)
Experimental AQ001S 0.125 mg/mL bis in die
AQ001S 0.125 mg/mL inhalation solution administered by inhalation twice a day + placebo by inhalation twice a day
干预措施: Drug, inhalation (Drug)
Comparator: placebo
No active drug - administered by inhalation 4 times a day
干预措施: Drug, inhalation (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 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)
时间窗: 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.
次要结局
- Time to hospital readmission(After 28 days of treatment)
- Time to mechanical ventilation(After 28 days of treatment)
- Occurrence of death(Within 60 days from hospitalisation)
- Modified Medical Research Council Dyspnea Scale(to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5))
- Pulmonary function measurement: FEV1/FVC ratio(At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5))
- Time to Intensive Care Unit admission(After 28 days of treatment)
- Length of Intensive Care Unit stay(After 28 days of treatment)
- 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))
- 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))
- Pulmonary function measurement: SpO2/FiO2 ratio(At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5))
- Time to hospital discharge(After 28 days of treatment)
- Pulmonary function measurement: Forced Vital Capacity (FVC)(At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5))
- Pulmonary function measurement: Oxygen saturation (SpO2)(At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5))
- Pulmonary CT Scan(After 28 days of treatment)
- Length of hospital readmission(After 28 days of treatment)
- Diffusion Capacity for Carbon Monoxide measurements(At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5))