Status:
TERMINATED
A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19
Lead Sponsor:
Syndax Pharmaceuticals
Conditions:
Coronavirus
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care (SOC), compared with placebo plus SOC, in participants with ...
Detailed Description
Axatilimab (SNDX-6352) is a humanized immunoglobin G4 monoclonal antibody with high affinity against colony stimulating factor-1 receptor (CSF-1R) under investigation for the prevention or treatment o...
Eligibility Criteria
Inclusion
- Type of Participant and Disease Characteristics -
- Documented or confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by an FDA-approved polymerase chain reaction test of nasopharyngeal swab or stool less than 72 hours before randomization
- Hospitalized for COVID-19
- Illness of any duration with at least 1 of the following:
- Clinical assessment (evidence of rales/crackles on exam) and peripheral capillary oxygen saturation less than or equal to 94% on room air, or
- Requiring mechanical ventilation and/or supplemental oxygen, or
- Radiographic evidence (chest x-ray or computed tomography scan) of 1 of the following:
- Ground-glass opacities, or
- Local or bilateral patchy infiltrates, or
- Interstitial pulmonary infiltrates
- If the participant was intubated, must have been intubated less than 24 hours prior to randomization
- Sex and Contraception Guidelines -
- Contraceptive use by men or women should have been consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Informed Consent -
- Capable of giving signed informed consent or by a designated representative, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
Exclusion
- Medical Conditions -
- Active bacterial pneumonia defined: based on either lobar consolidation on x-ray, positive sputum cultures, or leukocytosis with a left shift
- Known active tuberculosis
- Participants with acquired immune deficiency syndrome
- It is not in the best interest of the participants to participate, in the opinion of the treating Investigator.
- In the opinion of the investigator, progression to death was imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- Female participants who were pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study intervention
- Excluded Prior/Concomitant Therapy -
- Prior treatment with other agents with actual or possible direct acting anti-inflammatory activity against SARS-CoV-2 in the past 30 days (for example, chloroquine, hydroxychloroquine)
- Treatment with convalescent plasma
- Treatment with high doses of corticosteroids (greater than 20 milligrams daily, prednisone equivalent) prior to randomization
- Treatment with immunomodulators including anti-interleukin (IL)-6, anti-IL-6 receptor antagonists, or with Janus kinase inhibitors in the past 30 days or plans to receive during the study period
- Previous exposure to study intervention or any other agent targeting colony stimulating factor-1 or CSF-1R or known allergy/sensitivity to study intervention
Key Trial Info
Start Date :
May 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04415073
Start Date
May 30 2020
End Date
July 13 2020
Last Update
July 22 2022
Active Locations (2)
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1
HonorHealth
Scottsdale, Arizona, United States, 85258
2
Montefiore Medical Center
The Bronx, New York, United States, 10467