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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 07 Sep 2020

At a glance

  • Drugs ODN/Pam2 (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Sponsors Pulmotect
  • Most Recent Events

    • 03 Sep 2020 Planned End Date changed from 1 Oct 2020 to 1 Dec 2020.
    • 03 Sep 2020 Planned primary completion date changed from 1 Sep 2020 to 1 Oct 2020.
    • 11 May 2020 Status changed from not yet recruiting to recruiting.

Trial Overview

Purpose

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.

Primary Endpoints

Severity of COVID-19

description: 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.
time_frame: 28 days

Other Endpoints

SARS-CoV-2 infection

description: SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy
time_frame: 28 days

Severity of COVID-19 over 14 days

description: 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.
time_frame: 14 days

Severity of COVID-19 symptoms

description: 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.
time_frame: 28 days

ICU admission

description: The requirement for ICU admission within 28 days from the start of the experimental therapy.
time_frame: 28 days

Mechanical Ventilation

description: The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.
time_frame: 28 days

Mortality

description: All cause mortality at 28 days from the start of experimental therapy
time_frame: 28 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 100

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient 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.

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04312997 ClinicalTrials.gov: US National Institutes of Health
PUL042-502 -

Organisations

  • Sponsors Pulmotect
  • Affiliations Pulmotect

Trial Dates

  • Initiation Dates

    Planned : 01 May 2020

    Actual : 16 Jun 2020

  • Primary Completion Dates

    Planned : 01 Oct 2020

  • End Dates

    Planned : 01 Dec 2020

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location USA
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
ODN/Pam2Primary Drug Inhalation Solution

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))

Sterile saline for inhalation

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

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Alpesh Amin, MD University of California Irvine USA
Anuj Malik, MD Ascension St. John USA
Bernard Garcia, MD Invesclinic US LLC USA
Brenton Scott, Ph D
713-579-9226 clinicaltrials@pulmotect.com
show details
-
Chai Mandapakala, MD St. Elizabeth Healthcare USA
Colin Broom, MD
832-315-4807
cbroom@pulmotect.com
show details
Pulmotect, Inc.
-
David Johnson, MD Premeir Urgent Care of California USA
Jeffrey B Rosen, MD Clinical Research of South Florida Alliance for Multispecialty Research USA
Kevin Bender, MD DBC Research Corp. USA
Tapan Kadia, MD MD Anderson Cancer Center USA
Terrance M Chang, MD Next Level Urgent Care USA

Centres

Centre Name Location Trial Centre Country
-
-
-
Ascension St. John Bartlesville, Oklahoma USA
Ascension St. John Tulsa, Oklahoma USA
Clinical Research of South Florida Alliance for Multispecialty Research Coral Gables, Florida USA
DBC Research Corp. Tamarac, Florida USA
Invesclinic US LLC Fort Lauderdale, Florida USA
MD Anderson Cancer Center Houston, Texas USA
Next Level Urgent Care Houston, Texas USA
Premeir Urgent Care of California San Bernardino, California USA
Pulmotect, Inc.
-
-
St. Elizabeth Healthcare Edgewood, Kentucky USA
University of California Irvine Orange, California USA

Trial History

Event Date Event Type Comment
07 Sep 2020 Other trial event Last checked against Clinicaltrials.gov record. Updated 07 Sep 2020
03 Sep 2020 Completion date Planned End Date changed from 1 Oct 2020 to 1 Dec 2020. Updated 07 Sep 2020
03 Sep 2020 Other trial event Planned primary completion date changed from 1 Sep 2020 to 1 Oct 2020. Updated 07 Sep 2020
11 May 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 13 May 2020
07 May 2020 Other trial event According to a Pulmotect media release , the company informed that in this week the first patient is enrolling in this study. Updated 11 May 2020
05 May 2020 Other trial event According to a Pulmotect media release, the company has received approval from the U.S. Food & Drug Administration (FDA) to initiate this study. Updated 26 May 2020
04 May 2020 Other trial event Planned initiation date changed from 1 Apr 2020 to 1 May 2020. Updated 07 May 2020
23 Mar 2020 New trial record New trial record Updated 23 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Pulmotect. PARI Nebulizer Used in New Study with Pulmotect's Inhaled PUL-042 for COVID-19. Media-Rel 2020;.

    Media Release
  3. Fannin Innovation Studio. Pulmotect receives FDA approval to commence two Phase-2 trials targeting COVID-19. Media-Rel 2020;.

    Media Release
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