The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection
- Registration Number
- NCT04312997
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Subjects must have a positive test for SARS-CoV-2.
- COVID-19 signs and symptoms such as (fever, cough, shortness of breath or fatigue) with onset within the 7 days prior to Screening
- Subjects should be Ordinal Scale for Clinical Improvement score of 4 or less.
- Subjects receiving oxygen should have pulse oximetry ≥ 93% on 3 liters per minute of oxygen or less delivered by nasal prongs.
- 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.
- Subject's spirometry (FEV1 and forced vital capacity [FVC]) must be ≥70% of predicted value.
- 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.
- 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.
- 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.
- Must have the ability to understand and give informed consent.
- No documented infection with SARS-CoV-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.
- 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.
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PUL-042 Inhalation Solution PUL-042 Inhalation Solution PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 Sterile saline for inhalation Placebo Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6
- Primary Outcome Measures
Name Time Method Number of Participants With Worsening of COVID-19 Within 28 Days 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 analysis is the evaluation of the number 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 (OSCI). The OSCI used in this study is derived from a draft scale proposed by the World Health Organization for clinical improvement. Higher values represent a worse outcome.
The OSCI is a nine-point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.
- Secondary Outcome Measures
Name Time Method Number of Participants With Positive SARS-CoV-2 Test Results at the End of Study 28 days SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy.
Time to Resolution of COVID-19 Symptoms 28 days The time to resolution of COVID-19 symptoms during the study was 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.
The time to the first occurrence of resolution of symptoms (in days) was defined as the time from the first symptom score of ≥1 to a symptom score of 0.Number of Participants Requiring ICU Admission 28 days The requirement for ICU admission within 28 days from the start of the experimental therapy.
Number of Participants Requiring Mechanical Ventilation 28 days The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.
Time to COVID-19 Symptom Improvement: Respiratory Symptoms 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.
The time to respiratory symptom improvement is measured in days. Time to improvement of symptoms was prospectively defined as the time from an initial symptom score of ≥1 to a reduction of ≥1 point. The time to improvement of symptoms was evaluated for each individual symptom listed above.Number of Participants With Worsening of COVID-19 Over 14 Days 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 (OSCI).
The OSCI is a nine-point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.Number of Participant Death 28 days All-cause mortality at 28 days from the start of experimental therapy.
Trial Locations
- Locations (10)
University of California Irvine
🇺🇸Orange, California, United States
Invesclinic US LLC
🇺🇸Fort Lauderdale, Florida, United States
DBC Research Corp.
🇺🇸Tamarac, Florida, United States
Premeir Urgent Care of California
🇺🇸San Bernardino, California, United States
Next Level Urgent Care
🇺🇸Houston, Texas, United States
Clinical Research of South Florida Alliance for Multispecialty Research
🇺🇸Coral Gables, Florida, United States
Affinity Clinical Research, LLC
🇺🇸Tampa, Florida, United States
St. Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, United States
Ascension St. John
🇺🇸Tulsa, Oklahoma, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States