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

NCT ID: NCT05000346

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-04
• Study Completion Date: 2022-12-21

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental AQ001S 0.125 mg/mL quarter in die

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

Group Type: EXPERIMENTAL

Drug, inhalation

Intervention Type: DRUG

Solution administered by inhalation

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

Group Type: EXPERIMENTAL

Drug, inhalation

Intervention Type: DRUG

Solution administered by inhalation

Comparator: placebo

No active drug - administered by inhalation 4 times a day

Group Type: PLACEBO_COMPARATOR

Drug, inhalation

Intervention Type: DRUG

Solution administered by inhalation

Interventions

Drug, inhalation

Solution administered by inhalation

Intervention Type: DRUG

Other Intervention Names

inhaled drug, including placebo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aquilon Pharmaceuticals S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien Guiot, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Liege

Locations

CHU Liege

Liège, , Belgium

Countries

Belgium

Other Identifiers

AQ-PRO-013

Identifier Type: -

Identifier Source: org_study_id