Experimental drug auxora tested in critical COVID-19 lung patients
NCT ID NCT04661540
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times
Summary
This small Phase 2 trial tested an experimental drug called Auxora in 10 patients with critical COVID-19 pneumonia who were on ventilators. The goal was to see how the drug affected immune cells in the lungs and to check its safety. The study was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Auxora (CM4620-IE)
- What this could lead to
- If successful, Auxora could help control severe immune reactions in critical COVID-19 pneumonia, potentially improving outcomes for ventilated patients.
- What could go wrong
- This was a very small, early-phase trial (only 10 participants) that was terminated early, so results are limited. The drug may not show clear benefit or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
10 people
The number who actually took part.
- Started
-
Mar 2021
- Finished
-
Dec 2021
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen; 2. Moderate ARDS characterized by the following criteria: * Invasive mechanical ventilation with a minimum PEEP of 5 cm H2O; * PaO2/FiO2 ≤200 that may be estimated from pulse oximetry or determined by arterial blood gas; * No evidence of volume overload or heart failure; 3. The patient is ≥18 years of age at the time of consent; 4. QTcF interval ≤ 440 milliseconds; 5. A female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug; 6. A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug. A male patient must not donate sperm for 39 months; 7. The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol. Exclusion Criteria: 1. Expected survival or time to withdrawal of life-sustaining treatments expected to be \<7 days. 2. ECMO; 3. Suspected septic shock; 4. The patient has a history of: * Organ or hematologic transplant; * HIV; * Active hepatitis B or hepatitis C infection; 5. Current treatment with: * Chemotherapy; * Immunosuppressive medications or immunotherapy (see Section 5.3 for list of prohibited immunosuppressive medications and immunotherapy) at the time of consent; * Hemodialysis or Peritoneal Dialysis; 6. The patient is known to be pregnant or is nursing; 7. Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent; 8. Allergy to eggs or any of the excipients in study drug.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
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Other studies related to the condition(s) this trial covers.
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