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TERMINATEDPHASE2

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

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

NCT05000346•Aquilon Pharmaceuticals S.A.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (1)

CHU Liege

Liège, Belgium

Key Dates

Start Date

November 4, 2021

Primary Completion Date

December 21, 2022

Completion Date

December 21, 2022

Last Updated

January 6, 2023

Enrollment

ACTUAL participants

Conditions

Covid19

Interventions

Drug, inhalation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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