A Clinical Safety Study on AT-100 in Treating Adults With Severe COVID-19 Infection or Severed Community Acquired Pneumonia

August 11, 2023 updated by: Airway Therapeutics, Inc.

Phase 1b Open-label, Single Arm, Cohort Dose Escalation Study Evaluating the Safety, Tolerability, and Feasibility of Intervention With AT-100 (rhSP-D) in Intubated Patients Receiving Invasive Mechanical Ventilation With Severe COVID-19 Infection or Respiratory Failure Secondary to Severe Community Acquired Pneumonia

The purpose of this study is to determine if an investigational drug, AT-100, is safe and tolerated by adults who have severe corona virus disease 2019 (COVID-19) or respiratory failure secondary to severe community acquired pneumonia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Airway Therapeutics Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The subject is an adult ≥18 years of age.
  2. The subject has documented, laboratory-confirmed SARS-CoV-2 infection within 2 weeks prior to enrollment, or meets criteria for severe community acquired pneumonia (CAP) specified in inclusion 3 below.
  3. The subject has severe SARS-CoV-2 infection requiring intubation and mechanical ventilation. Or, the subject is admitted for severe CAP with respiratory failure as demonstrated by the following:

3. i. Respiratory failure requiring intubation and mechanical ventilation, and 3. ii. A clinical diagnosis of CAP that includes radiographic findings of new pulmonary infiltrate(s) consistent with CAP plus any one of the following on admission to the hospital: 3. ii. 1. Fever (Temperature > 38.0°C), 3. ii. 2. Hypothermia (Temperature < 36.0°C), 3. ii. 3. Leukocytosis with White Blood Cells (WBC) > 10,000 cells/µL or immature band forms > 10%, 3. ii. 4. Leukopenia with WBC < 4,000 cells/µL, or 3. ii. 5. Hypotension Mean Arterial Pressure (MAP) < 70 mmHg, requiring the initiation of vasopressor support.

4. The subject has been receiving mechanical ventilation for <72 hours. 5. The subject is receiving mechanical ventilation due to respiratory disease that is primarily due to SARS-CoV-2 infection or CAP.

6. The subject, or legally authorized representative if acting on the subject's behalf, is able to provide informed consent.

Exclusion Criteria:

  1. The subject refuses to participate, or the subject's legally authorized representative acting on the subject's behalf refuses the subject's participation.
  2. The subject is pregnant or breastfeeding.
  3. The subject is anticipated to be transferred to another hospital that is not a study site within 36 hours of enrollment.
  4. The subject has received or is receiving extracorporeal membrane oxygenation (ECMO) treatment for COVID-19 or CAP treatment.
  5. The subject has Human Immunodeficiency virus (HIV) under highly active antiretroviral therapy (HAART).
  6. The subject has cancer and is receiving chemotherapy treatment at any time during trial duration, or has received chemotherapy treatment within 30 days of trial enrollment.
  7. The subject has a prior history of lung transplant, lobectomy, or other significant lung surgeries that would indicate an already compromised lung.
  8. The subject has known pulmonary air leaks, such as pneumothorax and pneumomediastinum.
  9. Concurrent enrollment in an investigational product, device, or treatment trial or is projected to participate in any other trial that alters the standard of care during the period of this study
  10. The subject has a known allergy, sensitivity, or contraindication to any component of the test article (AT-100).
  11. The subject has any active do not resuscitate (DNR)-Comfort Care (CC) order in place. Subjects with an active DNR-Comfort Care Arrest (CCA) are not excluded.
  12. The subject's intubation, re-intubation, or remaining on intubation is not per clinical standard-of-care and is solely for the purposes of administration of study drug.
  13. The subject has any condition or is in a situation in which, in the Investigator's judgement, puts the subject at significant risk, could confound the trial results, or may significantly interfere with the subject's trial participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AT-100 75 mg
Once daily AT-100 via intratracheal administration for up to 7 doses.
Biological: AT-100
reconstituted AT-100 for intratracheal administration
Other Names:
  • (rhSP-D)
Experimental: AT-100 150 mg
Once daily AT-100 via intratracheal administration for up to 7 doses, if the prior dose level was safe & tolerated.
Biological: AT-100
reconstituted AT-100 for intratracheal administration
Other Names:
  • (rhSP-D)
Experimental: AT-100 75 mg or 150 mg (Optional Cohort)
Once daily AT-100 via intratracheal administration for up to 7 doses, at the highest safe & tolerated dose as determined by the prior 2 dosing levels.
Biological: AT-100
reconstituted AT-100 for intratracheal administration
Other Names:
  • (rhSP-D)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determining the highest-tolerated & safety-tested AT-100 dose
Time Frame: From time of initial AT-100 dosing until the end of the dosing period, up to 7 days
Dose escalation of AT-100 will occur to determine the maximum dose (in mg) that produces no significant Dose Limiting Toxicities or dose-related Adverse Events (AEs).
From time of initial AT-100 dosing until the end of the dosing period, up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in mechanical ventilation
Time Frame: From mechanical ventilation initiation up to Day 28
Days on mechanical ventilation.
From mechanical ventilation initiation up to Day 28

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Through study completion, up to Day 90
Incidence of death.
Through study completion, up to Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Airway Therapeutics, Inc.

Investigators

  • Study Chair: Marc O. Salzberg, MD, Airway Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2021

Primary Completion (Actual)

February 23, 2023

Study Completion (Actual)

February 23, 2023

Study Registration Dates

First Submitted

December 4, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-100/002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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