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AT-100 (rhSP-D) in intubated patients receiving invasive mechanical ventilation with severe COVID-19

Alpesh Amin


A Study On:

  • Coronavirus Infection
  • Infection Disease

Status:

  • Open

Eligibility

18 Years and older (Adult, Older Adult)

Interested in joining this 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

Details

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


Eligibility

You can join if...

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.

Get in touch with our study team