Clinical trial NCT04312997: The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection
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
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: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adults who have tested positive for SARS-CoV-2 infection and who may 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


Eligibility criteria: Inclusion Criteria:

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 4 or less.
4. Subjects receiving oxygen should have pulse oximetry ≥ 93% on 3 liters per minute of oxygen or less delivered by nasal prongs.
5. Subjects can be receiving standard of care (SOC) for COVID-19, this includes marketed therapies or therapies with Emergency Use Authorization (EUA) 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.

Exclusion Criteria:

1. No documented infection with SARS-CoV-2.
2. Patients who are in respiratory distress or require high flow oxygen, non-invasive ventilation or mechanical ventilation (Ordinal Scale for Clinical Improvement \>4) or with pulse oximetry less than 93% on oxygen with a flow rate of 3 liters per minute or less by nasal prongs 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 or without EUA) 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

Primary outcomes:
measure: Number of Participants With Worsening of COVID-19 Within 28 Days
timeFrame: 28 days
Secondary outcomes:
measure: Number of Participants With Positive SARS-CoV-2 Test Results at the End of Study
timeFrame: 28 days
measure: Number of Participants With Worsening of COVID-19 Over 14 Days
timeFrame: 14 days
measure: Time to COVID-19 Symptom Improvement: Respiratory Symptoms
timeFrame: 28 days
measure: Time to Resolution of COVID-19 Symptoms
timeFrame: 28 days
measure: Number of Participants Requiring ICU Admission
timeFrame: 28 days
measure: Number of Participants Requiring Mechanical Ventilation
timeFrame: 28 days
measure: Number of Participant Death
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: Premeir 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: Tamarac
country: United States
facility: DBC Research Corp.
state: Florida
city: Tampa
country: United States
facility: Affinity Clinical Research, LLC
state: Florida
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Bartlesville
country: United States
facility: Ascension St. John
state: Oklahoma
city: Tulsa
country: United States
facility: Ascension St. John
state: Oklahoma
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: