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COVID-19Phase 1NCT04659122

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

A Phase 1 study testing AT-100 in people with COVID-19 and Undefined, run by Airway Therapeutics, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, Undefined
What is being tested?
AT-100
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
17 Aug 2021to 23 Feb 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is an adult ≥18 years of age.
  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Airway Therapeutics Investigational Site

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

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

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
Being tested
AT-100
Keywords
COVID-19, Mechanical Ventilation, Respiratory Support, recombinant human Surfactant Protein-D (rhSP-D), Community-acquired Pneumonia, CAP, zelpultide alfa
Medical subject headings
COVID-19, Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AT-100Biological

    Also called (rhSP-D)

    reconstituted AT-100 for intratracheal administration

Study groups in NCT04659122
Study groupRoleWhat they receive
AT-100 75 mgExperimentalOnce daily AT-100 via intratracheal administration for up to 7 doses.
Receives: Biological: AT-100
AT-100 150 mgExperimentalOnce daily AT-100 via intratracheal administration for up to 7 doses, if the prior dose level was safe \& tolerated.
Receives: Biological: AT-100
AT-100 75 mg or 150 mg (Optional Cohort)ExperimentalOnce 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.
Receives: Biological: AT-100

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From time of initial AT-100 dosing until the end of the dosing period, up to 7 days

Secondary outcomes (1)

  1. Reduction in mechanical ventilation

    Days on mechanical ventilation.

    Measured: From mechanical ventilation initiation up to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start17 Aug 2021
  3. Primary completion23 Feb 2023
  4. Study completion23 Feb 2023

Why it stopped: Termination / study goals reached

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Phase 1b portion is a dose escalation study to establish the safest \& most tolerable AT-100 dose.
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04659122
Sponsor's protocol ID
AT-100/002
Status last verified
Jul 2023
First submitted
4 Dec 2020
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 32864628

  • 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.

    PubMed 29473039

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AT-100 in people with COVID-19 and Undefined, run by Airway Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Termination / study goals reached). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04659122, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.

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