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

NCT04659122 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: AT-100/002
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Undefined

Keywords

COVID-19; Mechanical Ventilation; Respiratory Support; recombinant human Surfactant Protein-D (rhSP-D); Community-acquired Pneumonia; CAP; zelpultide alfa

Outcome Measures

Primary Outcomes (1)

• Determining the highest-tolerated & safety-tested AT-100 dose

  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 Outcomes (1)

• Reduction in mechanical ventilation

  From mechanical ventilation initiation up to Day 28

Other Outcomes (1)

• Mortality

  Through study completion, up to Day 90

Study Arms (3)

AT-100 75 mg

EXPERIMENTAL

Once daily AT-100 via intratracheal administration for up to 7 doses.

Biological: AT-100

AT-100 150 mg

EXPERIMENTAL

Once daily AT-100 via intratracheal administration for up to 7 doses, if the prior dose level was safe \& tolerated.

Biological: AT-100

AT-100 75 mg or 150 mg (Optional Cohort)

EXPERIMENTAL

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

Interventions

AT-100 BIOLOGICAL

reconstituted AT-100 for intratracheal administration

Also known as: (rhSP-D)

AT-100 150 mg; AT-100 75 mg; AT-100 75 mg or 150 mg (Optional Cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is an adult ≥18 years of age.
• 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:
• \. 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.
• \. 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.
• \. The subject, or legally authorized representative if acting on the subject's behalf, is able to provide informed consent.

You may not qualify if:

• The subject refuses to participate, or the subject's legally authorized representative acting on the subject's behalf refuses the subject's participation.
• The subject is pregnant or breastfeeding.
• The subject is anticipated to be transferred to another hospital that is not a study site within 36 hours of enrollment.
• The subject has received or is receiving extracorporeal membrane oxygenation (ECMO) treatment for COVID-19 or CAP treatment.
• The subject has Human Immunodeficiency virus (HIV) under highly active antiretroviral therapy (HAART).
• 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.
• The subject has a prior history of lung transplant, lobectomy, or other significant lung surgeries that would indicate an already compromised lung.
• The subject has known pulmonary air leaks, such as pneumothorax and pneumomediastinum.
• 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
• The subject has a known allergy, sensitivity, or contraindication to any component of the test article (AT-100).
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Airway Therapeutics, Inc.: lead

Study Sites (1)

Airway Therapeutics Investigational Site

Cincinnati, Ohio, 45229, United States

Location

Related Publications (2)

• Manson JJ, Crooks C, Naja M, Ledlie A, Goulden B, Liddle T, Khan E, Mehta P, Martin-Gutierrez L, Waddington KE, Robinson GA, Ribeiro Santos L, McLoughlin E, Snell A, Adeney C, Schim van der Loeff I, Baker KF, Duncan CJA, Hanrath AT, Lendrem BC, De Soyza A, Peng J, J'Bari H, Greenwood M, Hawkins E, Peckham H, Marks M, Rampling T, Luintel A, Williams B, Brown M, Singer M, West J, Jury EC, Collin M, Tattersall RS. COVID-19-associated hyperinflammation and escalation of patient care: a retrospective longitudinal cohort study. Lancet Rheumatol. 2020 Oct;2(10):e594-e602. doi: 10.1016/S2665-9913(20)30275-7. Epub 2020 Aug 21.

  PMID: 32864628 BACKGROUND

• Sorensen GL. Surfactant Protein D in Respiratory and Non-Respiratory Diseases. Front Med (Lausanne). 2018 Feb 8;5:18. doi: 10.3389/fmed.2018.00018. eCollection 2018.

  PMID: 29473039 BACKGROUND

Related Links

• Airway Therapeutics' corporate website

MeSH Terms

Conditions

COVID-19; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Community-Acquired Infections

Study Officials

• Marc O. Salzberg, MD

  Airway Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1b portion is a dose escalation study to establish the safest \& most tolerable AT-100 dose.

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 9, 2020
• Study Start: August 17, 2021
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-07

Locations

US (1)