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

• ClinicalTrials.gov Identifier: NCT04312997
• Recruitment Status: Recruiting
• First Posted: March 18, 2020
• Last Update Posted: June 4, 2020
• Sponsor: Pulmotect, Inc.
• Information provided by (Responsible Party): Pulmotect, Inc.

Study Description

Brief 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

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 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
• Estimated Study Start Date: June 2020
• Estimated Primary Completion Date: September 2020
• Estimated Study Completion Date: October 2020

Arms and Interventions

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

Outcome Measures

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) who do not require supplemental oxygen (Ordinal Scale for Clinical Improvement 3 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. ICU admission [ Time Frame: 28 days ]
   The requirement for ICU admission within 28 days from the start of the experimental therapy.
5. Mechanical Ventilation [ Time Frame: 28 days ]
   The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.
6. Mortality [ Time Frame: 28 days ]
   All cause mortality at 28 days from the start of experimental therapy

Eligibility Criteria

• 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 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.

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Colin Broom, MD; 713-579-9226; clinicaltrials@pulmotect.com

Contact: Brenton Scott, Ph D; 713-579-9226; clinicaltrials@pulmotect.com

Locations

United States, Kentucky

St. Elizabeth Healthcare; Recruiting

Edgewood, Kentucky, United States, 41017

Principal Investigator: Chai Mandapakala, MD

United States, Oklahoma

Ascension St. John; Recruiting

Tulsa, Oklahoma, United States, 74104

Principal Investigator: Anuj Malik, MD

Sponsors and Collaborators

Pulmotect, Inc.

Investigators

• Study Director: Colin Broom, MD; Pulmotect, Inc.

More Information

• Responsible Party: Pulmotect, Inc.
• ClinicalTrials.gov Identifier: NCT04312997
• Other Study ID Numbers: PUL-042-502
• First Posted: March 18, 2020
• Last Update Posted: June 4, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infection; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; PUL-042; Respiratory System Agents