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A Clinical Safety Study on AT-100 in Treating Adults With Severe COVID-19 Infection

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ClinicalTrials.gov Identifier: NCT04659122
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Airway Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 4, 2020
First Posted Date  ICMJE December 9, 2020
Last Update Posted Date August 31, 2021
Actual Study Start Date  ICMJE August 17, 2021
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
Reduction in mechanical ventilation [ Time Frame: From mechanical ventilation initiation up to Day 28 ]
Days on mechanical ventilation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 7, 2020)
Mortality [ Time Frame: Through study completion, up to Day 90 ]
Incidence of death.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Clinical Safety Study on AT-100 in Treating Adults With Severe COVID-19 Infection
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Phase 1b portion is a dose escalation study to establish the safest & most tolerable AT-100 dose.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE Biological: AT-100
reconstituted AT-100 for intratracheal administration
Other Name: (rhSP-D)
Study Arms  ICMJE
  • Experimental: AT-100 75 mg
    Once daily AT-100 via intratracheal administration for up to 7 doses.
    Intervention: Biological: AT-100
  • 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.
    Intervention: Biological: AT-100
  • Experimental: AT-100 75 mg or 150 mg
    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.
    Intervention: Biological: AT-100
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2020)
9
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  3. The subject has severe SARS-CoV-2 infection requiring intubation and mechanical ventilation.
  4. The subject has been receiving mechanical ventilation for <48 hours.
  5. The subject is receiving mechanical ventilation due to respiratory disease that is primarily due to SARS-CoV-2 infection.
  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 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 with exception of Remdesivir whether part of a clinical trial or standard-of-care management.
  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) order in place.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Neil P. Mills, BS 470-486-4688 mills@airwaytherapeutics.com
Contact: Kim M. Grabbe, MS 618-425-5424 grabbe@airwaytherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04659122
Other Study ID Numbers  ICMJE AT-100/002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Airway Therapeutics, Inc.
Study Sponsor  ICMJE Airway Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Marc O. Salzberg, MD Airway Therapeutics, Inc.
PRS Account Airway Therapeutics, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP