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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
101
20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)
Sterile saline for inhalation
University of California Irvine
Orange, California, United States
Premeir Urgent Care of California
San Bernardino, California, United States
Clinical Research of South Florida Alliance for Multispecialty Research
Coral Gables, Florida, United States
Number of Participants With Worsening of COVID-19 Within 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.
Time frame: 28 days
Number of Participants With Positive SARS-CoV-2 Test Results at the End of Study
SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy.
Time frame: 28 days
Number of Participants With Worsening of COVID-19 Over 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.
Time frame: 14 days
Time to COVID-19 Symptom Improvement: Respiratory Symptoms
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.
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Invesclinic US LLC
Fort Lauderdale, Florida, United States
DBC Research Corp.
Tamarac, Florida, United States
Affinity Clinical Research, LLC
Tampa, Florida, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, United States
Ascension St. John
Bartlesville, Oklahoma, United States
Ascension St. John
Tulsa, Oklahoma, United States
MD Anderson Cancer Center
Houston, Texas, United States
...and 1 more locations
Time frame: 28 days
Time to Resolution of COVID-19 Symptoms
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.
Time frame: 28 days
Number of Participants Requiring ICU Admission
The requirement for ICU admission within 28 days from the start of the experimental therapy.
Time frame: 28 days
Number of Participants Requiring Mechanical Ventilation
The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.
Time frame: 28 days
Number of Participant Death
All-cause mortality at 28 days from the start of experimental therapy.
Time frame: 28 days