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.

Criteria

    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.

Details

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

Interested in more information? Contact Us:

Clint Wilson, M.D., Principal Investigator
(318) 212-8130

IRB: Advarra Institutional Review Board
IRB Number:
Trial Type: Drug
Sponsor: Pulmotect