Summary

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

Description

Summary

Adults who have tested positive for SARS-CoV-2 infection and who do not require supplemental oxygen will receive PUL-042 Inhalation Solution or placebo 3 times over a one week period in addition to their normal care. Subjects will be be followed and assessed for their clinical status over 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome

Official Title

A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

Keywords

COVID-19 Infection Respiratory Aspiration 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 a positive test for SARS-CoV-2.
  2. COVID-19 signs and symptoms such as (fever, cough, shortness of breath or fatigue) with onset within the 7 days prior to Screening
  3. Subjects should be Ordinal Scale for Clinical Improvement score of 3 or less
  4. Pulse oximetry ≥ 93% on room air
  5. Subjects must be receiving standard of care (SOC) for COVID-19, this includes marketed therapies used for COVID-19 treatment.
  6. Subject's spirometry (FEV1 and forced vital capacity [FVC]) must be ≥70% of predicted value.
  7. 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.
  8. 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.
  9. 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.
  10. . Must have the ability to understand and give informed consent.

You CAN'T join if...

  1. No documented infection with SARS-CoV-2.
  2. Patients who require oxygen (Ordinal Scale for Clinical Improvement >3) at the time of screening.
  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. Exposure to any investigational therapy (defined as any agent not currently marketed) at the time of or within 30 days prior to the Screening Visit.
  5. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of trial endpoints

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • Ascension St. John accepting new patients
    Tulsa Oklahoma 74104 United States

Lead Scientist at UC Health

  • Alpesh Amin, MD (uci)
    Clinical Professor, Medicine. Authored (or co-authored) 204 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pulmotect, Inc.
ID
NCT04312997
Phase
Phase 2
Study Type
Interventional
Last Updated