Clinical trial NCT04313023: The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Pulmotect, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2020-03-18
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Subjects must have recent exposure to SARS-CoV-2 (such as repeated or extensive exposure to an infected individual(s) or cohabiting with a SARS-CoV-2 positive individual).
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.

Exclusion Criteria:

1. Previous infection with SARS-CoV-2.
2. Receipt of any vaccine for the prevention of COVID-19 (single or multiple doses).
3. 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).
4. 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.
5. Any condition which, in the opinion of the Principal Investigator, would prevent full participation

Primary outcomes:
measure: Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 28 Days From the Start of Experimental Therapy.
timeFrame: 28 days
Secondary outcomes:
measure: Percentage of SARS-CoV-2 Infections Through Day 29
timeFrame: 28 days
measure: Percentage of SARS-CoV-2 Infections Through Day 15
timeFrame: 14 days
measure: Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 14 Days From the Start of Experimental Therapy.
timeFrame: 14 days
measure: Number of Participants With ICU Admission
timeFrame: 28 days
measure: Number of Participants Requiring Mechanical Ventilation
timeFrame: 28 days
measure: Number of Participant Deaths
timeFrame: 28 days
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
city: San Bernardino
country: United States
facility: Premier Urgent Care of California
state: California
city: Coral Gables
country: United States
facility: Clinical Research of South Florida Alliance for Multispecialty Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Invesclinic US LLC
state: Florida
city: Miami
country: United States
facility: Luminous Cinical Research- South Florida Urgent Care
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: Tamarac
country: United States
facility: DBC Research
state: Florida
city: Tampa
country: United States
facility: Affinity Clinical Research, LLC
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Bossier City
country: United States
facility: Willis-Knighton Physcian Network
state: Louisiana
city: Bartlesville
country: United States
facility: Ascension St John
state: Oklahoma
city: Tulsa
country: United States
facility: Ascension St. John
state: Oklahoma
city: Edinburg
country: United States
facility: Invesclinic US LLC
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Next Level Urgent Care
state: Texas
Study officials:
affiliation: Pulmotect, Inc.
name: Colin Broom, MD
role: STUDY_DIRECTOR
References: