Study Title
A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2
Purpose
To determine if PUL-042 Inhalation Solution is successful in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: who have repeated exposure to individuals with SARS-CoV-2 infection, and 2) are asymptomatic at enrollment.
Eligibility
Subjects must have documented exposure to SARS-CoV-2 (defined as repeated daily exposure to an infected individual(s) [such as cohabiting with a SARS-CoV-2 positive individual] or involved in the assessment or care of COVID-19 patients without adequate PPE such as non-availability of a N95 mask)
Subjects must be 50 years or older if the exposure is due to cohabitation.
Subjects must be free of clinical signs or symptoms of a potential COVID-19 diagnosis
You Cannot:
Have a previous infection with SARS-CoV-2.
Have SARS-CoV-2 infection symptoms at the time of screening
Have a known history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure.
Study Process
No cost to the patient or insurance
Free Covid-19 testing
Patient stipend $75 per completed visit up to $525
6 Visits
Medication is delivered via Nebulizer in the clinic
Trial Details
Investigator:
Clint Wilson, M.D.
IRB:
Advarra Institutional Review Board
IRB Number:
Trial Type:
Drug
Sponsor:
Pulmotect
Contact Information:
(318) 212-8130