Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion
Principal Investigator
by Alpesh Amin, MD (uci)

Description

Summary

Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.

Official 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

Keywords

COVID-19 Infection Disease Progression PUL-042 PUL-042 Inhalation Solution Sterile saline for inhalation

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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).
  2. Subjects must be 50 years or older if the exposure is due to cohabitation.
  3. Subjects must be free of clinical signs or symptoms of a potential COVID-19 diagnosis (Ordinal Scale of Clinical Improvement score of 0) with a SARS-CoV-2 infection symptom score (fever, cough, shortness of breath, and fatigue) of 0 in each category.
  4. Spirometry (forced expiratory volume in one second FEV1 and forced vital capacity [FVC]) ≥70% of predicted value.
  5. If female, the subject must be surgically sterile or ≥ 1 year postmenopausal. If of child-bearing potential (including being < 1years postmenopausal) and, if participating in sexual activity that may lead to pregnancy, the subject agrees to use an effective dual method of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study.
  6. If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.
  7. If male, must be surgically sterile or, if not surgically sterile and if participating in sexual activities that may lead to pregnancy, be willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study.
  8. Ability to understand and give informed consent.

You CAN'T join if...

  1. Previous infection with SARS-CoV-2.
  2. A SARS-CoV-2 infection symptom score greater than 0 in any of the 4 catergories (fever, cough, shortness of breath or fatigue) at the time of screening (Ordinal Scale for Clinical Improvement score of 0).
  3. 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.
  4. Any condition which, in the opinion of the Principal Investigator, would prevent full participation

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • Premier Urgent Care of California not yet accepting patients
    San Bernardino California 92404 United States

Lead Scientist at UC Health

  • Alpesh Amin, MD (uci)
    Clinical Professor, Medicine. Authored (or co-authored) 206 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pulmotect, Inc.
ID
NCT04313023
Phase
Phase 2
Study Type
Interventional
Last Updated