Clinical Trial to Assess the Efficacy and Safety of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms (SIROCCO-1)

Aquilon Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Covid19

Treatments: Drug: Drug, inhalation

Study type: Interventional

Funder types: Industry

Identifiers

NCT05000346

AQ-PRO-013

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 3 patient groups, including a placebo group

Experimental AQ001S 0.125 mg/mL quarter in die

Experimental group

Description:

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

Treatment:

Drug: Drug, inhalation

Experimental AQ001S 0.125 mg/mL bis in die

Experimental group

Description:

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

Treatment:

Drug: Drug, inhalation

Comparator: placebo

Placebo Comparator group

Description:

No active drug - administered by inhalation 4 times a day

Treatment:

Drug: Drug, inhalation