Status:
TERMINATED
COVID-19 and Anti-CD14 Treatment Trial
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
University of Washington
Implicit Bioscience
Conditions:
Coronavirus Disease 2019 (COVID-19)
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study aims to address the following objectives: 1. To determine the efficacy of IC14, an anti-CD14 chimeric monoclonal antibody, in patients hospitalized with respiratory disease and hypoxemia d...
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled study of IC14, an antibody to CD14, in reducing the severity of respiratory disease in hospitalized Coronavirus Disease 2019 (COVID-...
Eligibility Criteria
Inclusion
- Patients included in the study must meet all the following criteria:
- Patient or legally authorized representative able to provide informed consent
- Presence of SARS-CoV-2 infection documented by positive RT-PCR testing or history of positive RT-PCR test for SARS-CoV-2 within 7 days of screening
- Radiologic findings compatible with diagnosis of SARS-CoV-2 pulmonary infection
- Hypoxemia as defined by any of the following:
- SpO2 ≤94% on room air, or
- Requirement for ≥2L/m O2 per standard nasal cannula to maintain SpO2≥94%, but not requiring high-flow nasal cannula (defined as ≥30 L/m), and
- Negative pregnancy test for women of childbearing potential and, must be willing to use birth control for the duration of the study.
Exclusion
- An individual fulfilling any of the following criteria should be excluded from enrollment in the study:
- Receiving non-invasive positive-pressure ventilation through nasal mask, face mask, or nasal plugs
- Receiving invasive mechanical ventilation
- Patient, surrogate, or physician not committed to full support
- -Exception: a participant will not be excluded if he/she would receive all supportive care other than attempts at resuscitation from cardiac arrest)
- Anticipated survival \<48 hours
- Underlying malignancy, or other condition, with estimated life expectancy of less than two months
- Significant pre-existing organ dysfunction prior to randomization
- Lung: Currently receiving home oxygen therapy as documented in medical record
- Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record
- Renal: End-stage renal disease requiring renal replacement therapy or eGFR \<30 mL/min
- Liver: Severe chronic liver disease defined as Child-Pugh Class C or AST or ALT \>5x upper limit of normal
- Hematologic: Baseline platelet count \<50,000/mm\^3
- Presence of co-existing infection, including, but not limited to:
- HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell/mm\^3
- Active tuberculosis or a history of inadequately treated tuberculosis
- Active hepatitis B or hepatitis C viral infection
- Ongoing immunosuppression
- Solid organ transplant recipient
- High-dose corticosteroids (equivalent to \>20 mg/prednisone/day) within the past 28 days, except for dexamethasone except for dexamethasone or equivalent treatment for COVID-19 illness
- Oncolytic drug therapy within the past 14 days
- Current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), certolizumab (Cimzia®), golimumab (Simponi®), anakinra (Kineret®), rilonacept (Arcalyst®), tocilizumab (Actemra®), sarilumab (Kevzara®), siltuximab (Sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments
- Current treatment with an anti-viral medication for COVID-19 (e.g. hydroxychloroquine, lopinavir/ritonavir), other than remdesivir
- Current enrollment in an interventional trial for COVID-19
- History of hypersensitivity or idiosyncratic reaction to IC14
- Women who are currently breastfeeding
- Received a live-attenuated vaccine within 30 days prior to enrollment
- Received five or more doses of remdesivir, including the loading dose, outside of the study as treatment for COVID-19, or
- Any condition that in the opinion of the treating physician will increase the risk for the participant.
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2022
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04391309
Start Date
April 12 2021
End Date
February 4 2022
Last Update
June 26 2023
Active Locations (5)
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1
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34236
2
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
3
Harborview Medical Center
Seattle, Washington, United States, 98104
4
Swedish Medical Center
Seattle, Washington, United States, 98122