A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19
NCT04415073 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2022-07-22
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 respiratory signs and symptoms secondary to COVID-19.
Conditions
- Coronavirus
- COVID
- ARDS
- Cytokine Storm
- Cytokine Release Syndrome
Interventions
- DRUG
-
SNDX-6352
SNDX-6352
- DRUG
-
Placebo comparator
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-30
- Primary Completion
- 2020-07-13
- Completion
- 2020-07-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Safety and Tolerability of XmAb®7195 in Adult Healthy Volunteers and Adult Subjects With a History of Allergic Rhinitis and/or Allergic Conjunctivitis and/or Atopic Dermatitis
NCT02148744 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
NCT02780674 ·Status: COMPLETED ·Phase: PHASE1
-
Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection
NCT04381052 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy of Ruxolitinib for COVID-19
NCT04348071 ·Status: WITHDRAWN ·Phase: PHASE2/PHASE3
-
Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19)
NCT04348500 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment of SARS Caused by COVID-19 With Ruxolitinib
NCT04334044 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients
NCT04646603 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
NCT06572384 ·Status: RECRUITING ·Phase: PHASE3
-
Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation
NCT04492514 ·Status: COMPLETED ·Phase: PHASE2
-
Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation
NCT04463004 ·Status: COMPLETED ·Phase: PHASE2
-
Infliximab in the Treatment of Patients With Severe COVID-19 Disease
NCT04922827 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.
NCT04324021 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD
NCT06843408 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Treatment of Granulomatous and Lymphocytic Interstitial Lung Disease in Patients With Common Variable Immunodeficiency
NCT02789397 ·Status: WITHDRAWN ·Phase: PHASE2
-
Efficacy of Intravenous Anakinra and Ruxolitinib During COVID-19 Inflammation
NCT04366232 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
NCT06388564 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis
NCT04438382 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
NCT06585774 ·Status: RECRUITING ·Phase: PHASE3
-
A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)
NCT03075904 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases
NCT06342713 ·Status: RECRUITING ·Phase: PHASE1
-
Therapeutic Plasma Exchange Alone or in Combination With Ruxolitinib in COVID-19 Associated CRS
NCT04374149 ·Status: COMPLETED ·Phase: PHASE2
-
Ruxolitinib to Combat COVID-19
NCT04354714 ·Status: WITHDRAWN ·Phase: PHASE2
-
Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19
NCT04347226 ·Status: TERMINATED ·Phase: PHASE2
-
IC14 Antibodies to Treat Individuals With Acute Lung Injury
NCT00233207 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19
NCT04605926 ·Status: WITHDRAWN ·Phase: PHASE3