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The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

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ClinicalTrials.gov Identifier: NCT04312997
Recruitment Status : Completed
First Posted : March 18, 2020
Last Update Posted : July 16, 2021
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Pulmotect, Inc.

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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: PUL-042 Inhalation Solution Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 16, 2020
Actual Primary Completion Date : July 2, 2021
Actual Study Completion Date : July 2, 2021

Arm Intervention/treatment
Experimental: PUL-042 Inhalation Solution
PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6
Drug: PUL-042 Inhalation Solution
20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)

Placebo Comparator: Sterile saline for inhalation
Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6
Drug: Placebo
Sterile saline for inhalation




Primary Outcome Measures :
  1. Severity of COVID-19 [ Time Frame: 28 days ]

    To determine the efficacy of PUL-042 Inhalation Solution in decreasing the severity of COVID-19 in subjects: 1) who have documented SARS-CoV-2 infection, and 2) if receiving oxygen, should have pulse oximetry ≥ 93% on 3 liters per minute of oxygen or less delivered by nasal prongs (Ordinal Scale for Clinical Improvement 4 or less) at the time of enrollment.

    The primary endpoint is the difference in the proportion of patients with clinically meaningful worsening of COVID-19 within 28 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement.

    The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.



Secondary Outcome Measures :
  1. SARS-CoV-2 infection [ Time Frame: 28 days ]
    SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy

  2. Severity of COVID-19 over 14 days [ Time Frame: 14 days ]

    To determine the difference in the proportion of COVID-19 patients with clinically meaningful worsening of COVID-19 within 14 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement.

    The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.


  3. Severity of COVID-19 symptoms [ Time Frame: 28 days ]

    To assess the progression of COVID-19 severity during the study as measured by the SARS-CoV-2 Symptom Score.

    The SARS-CoV-2 Symptom Score measures 3 elements on a 0-3 scale (cough, shortness of breath or difficulty breathing, and muscle aches or fatigue) ranging from 0 for none to 3 for severe. The fourth element is fever and it is rated on a 0-4 scale with 0 being no fever and 4 being life-threatening.


  4. Severity of COVID-19 symptoms [ Time Frame: 28 days ]
    To assess the progression of COVID-19 severity during the study as measured by the Ordinal Scale for Clinical Improvement.

  5. ICU admission [ Time Frame: 28 days ]
    The requirement for ICU admission within 28 days from the start of the experimental therapy.

  6. Mechanical Ventilation [ Time Frame: 28 days ]
    The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.

  7. Mortality [ Time Frame: 28 days ]
    All cause mortality at 28 days from the start of experimental therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04312997


Locations
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United States, California
University of California Irvine
Orange, California, United States, 92868
Premeir Urgent Care of California
San Bernardino, California, United States, 92404
United States, Florida
Clinical Research of South Florida Alliance for Multispecialty Research
Coral Gables, Florida, United States, 33134
Invesclinic US LLC
Fort Lauderdale, Florida, United States, 33308
DBC Research Corp.
Tamarac, Florida, United States, 33321
Affinity Clinical Research, LLC
Tampa, Florida, United States, 33612
United States, Kentucky
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
United States, Oklahoma
Ascension St. John
Bartlesville, Oklahoma, United States, 74006
Ascension St. John
Tulsa, Oklahoma, United States, 74104
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Next Level Urgent Care
Houston, Texas, United States, 77057
Sponsors and Collaborators
Pulmotect, Inc.
United States Department of Defense
Investigators
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Study Director: Colin Broom, MD Pulmotect, Inc.
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Responsible Party: Pulmotect, Inc.
ClinicalTrials.gov Identifier: NCT04312997    
Other Study ID Numbers: PUL-042-502
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
PUL-042
Respiratory System Agents