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A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2

Trial Profile

A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Mar 2021

At a glance

  • Drugs ODN/Pam2 (Primary)
  • Indications SARS-CoV-2 acute respiratory disease
  • Focus Therapeutic Use
  • Sponsors Pulmotect
  • Most Recent Events

    • 22 Feb 2021 Planned End Date changed from 1 May 2021 to 1 Jun 2021.
    • 22 Feb 2021 Planned primary completion date changed from 1 Apr 2021 to 1 May 2021.
    • 12 Jan 2021 Planned End Date changed from 1 Mar 2021 to 1 May 2021.

Trial Overview

Purpose

Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.

Primary Endpoints

Severity of COVID-19

description: To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment.
The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 28 days from the start of experimental therapy.
time_frame: 28 days

Other Endpoints

Incidence of SARS-CoV-2 infection

description: Positive test for SARS-CoV-2 infection 28 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit
time_frame: 28 days

Incidence of SARS-CoV-2 infection

description: Positive test for SARS-CoV-2 infection 14 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit
time_frame: 14 days

Severity of COVID-19

description: The severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 14 days from the start of experimental therapy.
time_frame: 14 days

ICU admission

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

Mechanical ventilation

description: The requirement for mechanical ventilation within 28 days from the start of 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
SARS-CoV-2 acute respiratory disease treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 200

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

Patient Inclusion Criteria

1. Subjects must have recent exposure to SARS-CoV-2 (such as repeated or extensive exposure to an infected individual(s) or cohabiting with a SARS-CoV-2 positive individual). 2. Subjects must be 50 years or older if the exposure is due to cohabitation. 3. Subjects must be free of clinical signs or symptoms of a potential COVID-19 diagnosis (Ordinal Scale of Clinical Improvement score of 0) with a SARS-CoV-2 infection symptom score (fever, cough, shortness of breath, and fatigue) of 0 in each category. 4. Spirometry (forced expiratory volume in one second FEV1 and forced vital capacity [FVC]) ≥70% of predicted value. 5. 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. 6. 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. 7. 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. 8. Ability to understand and give informed consent.

Patient Exclusion Criteria

1. Previous infection with SARS-CoV-2. 2. Receipt of any vaccine for the prevention of COVID-19 (single or multiple doses). 3. A SARS-CoV-2 infection symptom score greater than 0 in any of the 4 catergories (fever, cough, shortness of breath or fatigue) at the time of screening (Ordinal Scale for Clinical Improvement score of 0). 4. 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. 5. Any condition which, in the opinion of the Principal Investigator, would prevent full participation

Trial Details

Identifiers

Identifier Owner
NCT04313023 ClinicalTrials.gov: US National Institutes of Health
PUL042-501 -

Organisations

  • Sponsors Pulmotect
  • Affiliations Pulmotect

Trial Dates

  • Initiation Dates

    Planned : 01 May 2020

    Actual : 09 Jun 2020

  • Primary Completion Dates

    Planned : 01 May 2021

  • End Dates

    Planned : 01 Jun 2021

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, 6, and 10
Drug: PUL-042 Inhalation Solution (20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution)

Sterile saline for inhalation

Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10
Drug: Placebo (Sterile saline for inhalation)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Aldofo Cueli, MD Entrust Clinical Research USA
Alpesh Amin, MD University of California Irvine USA
Anuj Malik, MD Ascension St John, Ascension St. John USA
Ausberto Hidalgo, MD Luminous Cinical Research- South Florida Urgent Care USA
Bernard Garcia, MD Invesclinic US LLC USA
Brenton Scott, Ph D
713-579-9226 clincaltrials@pulmotect.com
show details
-
Clint Wilson, MD Willis-Knighton Physcian Network USA
Colin Broom, MD
832-315-4807
cbroom@pulmotect.com
show details
Pulmotect, Inc.
-
David Johnson, MD Premier Urgent Care of California USA
German Alvarez, MD Affinity Clinical Research, LLC USA
Kevin Bender, MD DBC Research USA
Monzer Yazi, MD Invesclinic US LLC USA
Nathan Segall, MD Clinical Research Atlanta 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
-
-
-
Affinity Clinical Research, LLC Tampa, Florida USA
Ascension St John Bartlesville, Oklahoma USA
Ascension St. John Tulsa, Oklahoma USA
Clinical Research Atlanta Stockbridge, Georgia USA
Clinical Research of South Florida Alliance for Multispecialty Research Coral Gables, Florida USA
DBC Research Tamarac, Florida USA
Englewood Health Englewood, New Jersey USA
Entrust Clinical Research Miami, Florida USA
Invesclinic US LLC Edinburg, Texas USA
Invesclinic US LLC Fort Lauderdale, Florida USA
Luminous Cinical Research- South Florida Urgent Care Miami, Florida USA
MD Anderson Cancer Center Houston, Texas USA
Next Level Urgent Care Houston, Texas USA
Premier Urgent Care of California San Bernardino, California USA
Pulmotect, Inc.
-
-
United States Department of Defense
-
-
University of California Irvine Orange, California USA
Willis-Knighton Physcian Network Bossier City, Louisiana USA

Trial History

Event Date Event Type Comment
19 Mar 2021 Other trial event Last checked against Clinicaltrials.gov record. Updated 19 Mar 2021
22 Feb 2021 Completion date Planned End Date changed from 1 May 2021 to 1 Jun 2021. Updated 25 Feb 2021
22 Feb 2021 Other trial event Planned primary completion date changed from 1 Apr 2021 to 1 May 2021. Updated 25 Feb 2021
12 Jan 2021 Completion date Planned End Date changed from 1 Mar 2021 to 1 May 2021. Updated 14 Jan 2021
12 Jan 2021 Other trial event Planned primary completion date changed from 1 Jan 2021 to 1 Apr 2021. Updated 14 Jan 2021
16 Oct 2020 Completion date Planned End Date changed from 1 Nov 2020 to 1 Mar 2021. Updated 22 Oct 2020
16 Oct 2020 Other trial event Planned primary completion date changed from 1 Oct 2020 to 1 Jan 2021. Updated 22 Oct 2020
03 Sep 2020 Completion date Planned End Date changed from 1 Oct 2020 to 1 Nov 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
02 Jun 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 05 Jun 2020
19 May 2020 Other trial event According to a Pulmotect media release, he trial is active and will be conducted at up to 10 clinical sites throughout the country, starting with St. Elizabeth in Northern Kentucky, the first hospital site in the world to be able to start dosing patients. Updated 26 May 2020
19 May 2020 Other trial event According to a Pulmotect media release, St. Elizabeth Healthcare has been selected as the first site of this study in partnership in partnership with CTI - Clinical Trial and Consulting Services (CTI), a global full-service contract research organization. Updated 26 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 2021;.

    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. St. Elizabeth Healthcare. St. Elizabeth Healthcare Partners with CTI and Pulmotect Becoming First Hospital Site for Phase-2 Clinical Trial Targeting COVID-19. Media-Rel 2020;.

    Media Release
  4. 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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