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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.

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).

Condition or disease Intervention/treatment Phase
Covid19 Biological: AT-100 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
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
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
Actual Study Start Date : August 17, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

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 Name: (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 Name: (rhSP-D)

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.
Biological: AT-100
reconstituted AT-100 for intratracheal administration
Other Name: (rhSP-D)




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Reduction in mechanical ventilation [ Time Frame: From mechanical ventilation initiation up to Day 28 ]
    Days on mechanical ventilation.


Other Outcome Measures:
  1. Mortality [ Time Frame: Through study completion, up to Day 90 ]
    Incidence of death.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659122


Contacts
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Contact: Neil P. Mills, BS 470-486-4688 mills@airwaytherapeutics.com
Contact: Kim M. Grabbe, MS 618-425-5424 grabbe@airwaytherapeutics.com

Locations
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United States, California
Airway Therapeutics Investigational Site Recruiting
Orange, California, United States, 92868
United States, Ohio
Airway Therapeutics Investigational Site Recruiting
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Airway Therapeutics, Inc.
Investigators
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Study Chair: Marc O. Salzberg, MD Airway Therapeutics, Inc.
Additional Information:
Publications:
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Responsible Party: Airway Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04659122    
Other Study ID Numbers: AT-100/002
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Airway Therapeutics, Inc.:
COVID-19
Mechanical Ventilation
Respiratory Support
recombinant human Surfactant Protein-D (rhSP-D)
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases