Clinical Trial to Assess the Efficacy and Safety of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms

NCT05000346 | Terminated Phase 2 DMC

• 1 other identifier: AQ-PRO-013
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Double-blind parallel trial to assess the efficacy and safety of inhaled AQ001S in the management of acute COVID-19 symptoms compared.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)

Secondary Outcomes (16)

• Time to hospital discharge

  After 28 days of treatment

• Time to Intensive Care Unit admission

  After 28 days of treatment

• Length of Intensive Care Unit stay

  After 28 days of treatment

• Time to hospital readmission

  After 28 days of treatment

• Length of hospital readmission

  After 28 days of treatment

Other Outcomes (13)

• Change immune system response

  After 28 days of treatment

• Change in monocyte count

  After 28 days of treatment

• Change in lymphocyte count

  After 28 days of treatment

Study Arms (3)

Experimental AQ001S 0.125 mg/mL quarter in die

EXPERIMENTAL

AQ001S 0.125 mg/mL inhalation solution administered by inhalation 4 times a day

Drug: Drug, inhalation

Experimental AQ001S 0.125 mg/mL bis in die

EXPERIMENTAL

AQ001S 0.125 mg/mL inhalation solution administered by inhalation twice a day + placebo by inhalation twice a day

Drug: Drug, inhalation

Comparator: placebo

PLACEBO COMPARATOR

No active drug - administered by inhalation 4 times a day

Drug: Drug, inhalation

Interventions

Drug, inhalation DRUG

Solution administered by inhalation

Also known as: inhaled drug, including placebo

Comparator: placebo; Experimental AQ001S 0.125 mg/mL bis in die; Experimental AQ001S 0.125 mg/mL quarter in die

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aquilon Pharmaceuticals S.A.: lead

Study Sites (1)

CHU Liege

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

COVID-19

Interventions

Pharmaceutical Preparations; Inhalation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Julien Guiot, MD

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: August 11, 2021
• Study Start: November 4, 2021
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)