Assessment of the safety and tolerability of inhaled aerosolised ethanol in adult volunteers for COVID-19

Phase 1

• Conditions: COVID-19 (SARS-CoV-2); Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12621000067875
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-27
• Last Update Posted: 1 February 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Able to understand, give consent, and comply with all scheduled study visits, procedures and restrictions.

2. Group 1. Healthy adult volunteers (6 participants) as judged by the investigator based on medical history, physical examination, vital signs, laboratory tests and ECG; and is a non-smoker defined as not having smoked (inhalation of tobacco/nicotine or drugs of abuse) for four weeks prior to the study.

3. Group 2 participants with underlying lung disease as specified - smokers (4 participants see below), asthmatics (4 participants) and patients with cystic fibrosis (4 participants). These patients should have no other associated co-morbidities such as cardiovascular, renal or liver - either diagnosed or suspected through the tests listed to be performed at screening. Their underlying condition must be stable as defined by no exacerbations or significant changes in their underlying condition or treatment for the past four weeks. The participant will be advised to have the permission of their treating physician to participate in this study.

4. Group 2 participants in the smokers group must be regular smokers as defined by the
minimum pack year history (1 pack/week for 6 months) and must be able to withhold
smoking for the duration of the testing as they will be in a non-smoking environment and will not be able to leave the premises during testing. These patients should also have no other associated co-morbidities such as cardiovascular, renal or liver - either diagnosed or suspected through the tests performed at screening.

Exclusion Criteria

1. Under the age of 18 years. No upper age limits.

2. The COVID-19 serology or swab test performed at screening is positive.

3. Participants with a known diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or who, at screening, have an FEV1/FVC reading on spirometry of less than 70% predicted which is indicative of COPD.

4. Participants in Group 2 who at screening have an FEV1 reading on spirometry of less than 40% predicted.

5. Positive hepatitis or HIV serology testing performed at screening.

6. Participant is pregnant or breast-feeding.

7. Participants known to be allergic or have reacted to alcohol in the past

8. Participants unable to be exposed to alcohol for any reason including religious or cultural reasons

9. In the opinion of the Investigator, the participant is unable to comply with the procedures required for the testing.

10. Previous history of alcohol dependence or abuse, defined as greater than 21 units per week for males and greater than 14 units per week for females. Where 1 unit equals 360 mL of beer, 150 mL wine or 45 mL of spirits.

11. No specific medications are to be avoided, although if in the opinion of the medical staff that a new medication reported prior to starting the study has the potential for an interaction with ethanol, the participant will be precluded from participating while on that medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified