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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04659122
• Other study ID #: AT-100/002
• Status: Terminated
• Phase: Phase 1
• Start date: August 17, 2021
• Est. completion date: February 23, 2023

Study information

• Verified date: July 2023
• Source: Airway Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Pneumonia
• Undefined

Intervention

Biological:
• AT-100
reconstituted AT-100 for intratracheal administration

Locations

Country	Name	City	State
United States	Airway Therapeutics Investigational Site	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Airway Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	Incidence of death.	Through study completion, up to Day 90
Primary	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	Reduction in mechanical ventilation	Days on mechanical ventilation.	From mechanical ventilation initiation up to Day 28

External Links

•   Airway Therapeutics' corporate website