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Trial record 2 of 6 for:    PUL-042

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.

Tracking Information
First Submitted Date  ICMJE March 16, 2020
First Posted Date  ICMJE March 18, 2020
Last Update Posted Date July 16, 2021
Actual Study Start Date  ICMJE June 16, 2020
Actual Primary Completion Date July 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
Severity of COVID-19 [ Time Frame: 14 days ]
Ordinal Scale for Clinical Improvement (score 1-8)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2021)
  • SARS-CoV-2 infection [ Time Frame: 28 days ]
    SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy
  • 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.
  • 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.
  • 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.
  • ICU admission [ Time Frame: 28 days ]
    The requirement for ICU admission within 28 days from the start of the experimental therapy.
  • Mechanical Ventilation [ Time Frame: 28 days ]
    The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.
  • Mortality [ Time Frame: 28 days ]
    All cause mortality at 28 days from the start of experimental therapy
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
All cause mortality [ Time Frame: 28 days ]
Death
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: PUL-042 Inhalation Solution
    20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)
  • Drug: Placebo
    Sterile saline for inhalation
Study Arms  ICMJE
  • Experimental: PUL-042 Inhalation Solution
    PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6
    Intervention: Drug: PUL-042 Inhalation Solution
  • Placebo Comparator: Sterile saline for inhalation
    Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2021)
101
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2020)
100
Actual Study Completion Date  ICMJE July 2, 2021
Actual Primary Completion Date July 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04312997
Other Study ID Numbers  ICMJE PUL-042-502
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pulmotect, Inc.
Study Sponsor  ICMJE Pulmotect, Inc.
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Study Director: Colin Broom, MD Pulmotect, Inc.
PRS Account Pulmotect, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP