Covid19Phase 2SIROCCO-1NCT05000346
Clinical Trial to Assess the Efficacy and Safety of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms
A Phase 2 study testing Drug, inhalation in people with Covid19, run by Aquilon Pharmaceuticals S.A. at 1 site in Belgium.
Trial summary
Double-blind parallel trial to assess the efficacy and safety of inhaled AQ001S in the management of acute COVID-19 symptoms compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Drug, inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Nov 2021to 21 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Double-blind parallel trial to assess the efficacy and safety of inhaled AQ001S in the management of acute COVID-19 symptoms compared.
Read the 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
- Being tested
- Drug, inhalation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug, inhalationDrug
Also called inhaled drug, including placebo
Solution administered by inhalation
| Study group | Role | What they receive |
|---|---|---|
| Experimental AQ001S 0.125 mg/mL quarter in die | Experimental | AQ001S 0.125 mg/mL inhalation solution administered by inhalation 4 times a day Receives: 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 Receives: Drug: Drug, inhalation |
| Comparator: placebo | Placebo comparator | No active drug - administered by inhalation 4 times a day Receives: Drug: Drug, inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Secondary outcomes (16)
Time to hospital discharge
Time to hospital ldischarge measured over the treatment period from baseline (visit 2) to day 28 (visit 5).
Measured: After 28 days of treatment
Time to Intensive Care Unit admission
Time to Intensive Care Unit admission measured over the treatment period from baseline (visit 2) to day 28 (visit 5).
Measured: After 28 days of treatment
Length of Intensive Care Unit stay
Length of Intensive Care Unit stay measured over the treatment period from baseline (visit 2) to day 28 (visit 5).
Measured: After 28 days of treatment
Time to hospital readmission
Time to hospital readmission measured over the treatment period from baseline (visit 2) to day 28 (visit 5).
Measured: After 28 days of treatment
Length of hospital readmission
Length of hospital readmission measured over the treatment period from baseline (visit 2) to day 28 (visit 5).
Measured: After 28 days of treatment
Time to mechanical ventilation
Time to mechanical ventilation measured over the treatment period from baseline (visit 2) to day 28 (visit 5).
Measured: After 28 days of treatment
Occurrence of death
Occurence of death (all deaths).
Measured: Within 60 days from hospitalisation
Modified Medical Research Council Dyspnea Scale
Change in modified Medical Research Council Dyspnea (mMRC) Scale from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5).
Minimum mMRC Scale value is 0 (e.g. "I only get breathless with strenuous exercise"). The maximum mMRC Scale value is 4 (e.g. "I am too breathless to leave the house" or "I am breathless when dressing", worse outcome).
Measured: to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: Forced Expiratory Volume in the first second (FEV1)
Changes in FEV1 measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2.
Measured: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: Forced Vital Capacity (FVC)
Changes in FVC measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2.
Measured: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: FEV1/FVC ratio
Changes in FEV1/FVC ratio from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2.
Measured: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: Oxygen saturation (SpO2)
Changes in SpO2 measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2.
Measured: 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)
Changes in FiO2 measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2.
Measured: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: SpO2/FiO2 ratio
Changes in and SpO2/FiO2 ratio measured from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2.
Measured: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Diffusion Capacity for Carbon Monoxide measurements
Changes in the Diffusion Capacity for Carbon Monoxide (DLCO) from baseline (Visit 2) to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2.
Measured: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary CT Scan
Changes in the pulmonary CT Scan between baseline (Visit 2) and Day 28±2 (Visit 5)
Measured: After 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start4 Nov 2021
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Why it stopped: Lack of patient to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquilon Pharmaceuticals S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julien Guiot, MD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000346
- Sponsor's protocol ID
- AQ-PRO-013
- Acronym
- SIROCCO-1
- Status last verified
- Jan 2023
- First submitted
- 24 Jun 2021
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05000346
- Acronym / sponsor ID
- SIROCCO-1 / AQ-PRO-013
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient to recruit
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Aquilon Pharmaceuticals S.A.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental AQ001S 0.125 mg/mL quarter in die | Experimental | Drug: Drug, inhalationAQ001S 0.125 mg/mL inhalation solution administered by inhalation 4 times a day |
| Experimental AQ001S 0.125 mg/mL bis in die | Experimental | Drug: Drug, inhalationAQ001S 0.125 mg/mL inhalation solution administered by inhalation twice a day + placebo by inhalation twice a day |
| Comparator: placebo | Placebo comparator | Drug: Drug, inhalationNo active drug - administered by inhalation 4 times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug, inhalationAlso: inhaled drug, including placeboSolution administered by inhalation | Drug | Comparator: placebo, Experimental AQ001S 0.125 mg/mL bis in die, Experimental AQ001S 0.125 mg/mL quarter in die |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 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)
Time frame: 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.
16 secondary outcomes
Time to hospital discharge
Time frame: After 28 days of treatment
Time to Intensive Care Unit admission
Time frame: After 28 days of treatment
Length of Intensive Care Unit stay
Time frame: After 28 days of treatment
Time to hospital readmission
Time frame: After 28 days of treatment
Length of hospital readmission
Time frame: After 28 days of treatment
Time to mechanical ventilation
Time frame: After 28 days of treatment
Occurrence of death
Time frame: Within 60 days from hospitalisation
Modified Medical Research Council Dyspnea Scale
Time frame: to Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: Forced Expiratory Volume in the first second (FEV1)
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: Forced Vital Capacity (FVC)
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: FEV1/FVC ratio
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: Oxygen saturation (SpO2)
Time frame: 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)
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary function measurement: SpO2/FiO2 ratio
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Diffusion Capacity for Carbon Monoxide measurements
Time frame: At Day 7±2 (Visit 3), Day 14±2 (Visit 4) and Day 28±2 (Visit 5)
Pulmonary CT Scan
Time frame: After 28 days of treatment
Results and safety
The study was stopped early (reason given: Lack of patient to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Guiot, MD principal investigator
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug, inhalation in people with Covid19, run by Aquilon Pharmaceuticals S.A. at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of patient to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: During 28 days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.