COVID-19 and Anti-CD14 Treatment Trial

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Coronavirus Disease 2019 (COVID-19), Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

In brief

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 due to SARS-CoV-2, in terms of improving the time to resolution of disease. 2. To determine the efficacy of IC14 in reducing the severity of respiratory disease in patients hospitalized with respiratory disease due to SARS-CoV-2. 3. To determine the safety of IC14 in patients hospitalized with respiratory disease due to SARS-CoV-2.

Key facts

Study ID

NCT04391309

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

49

Starts

2021-04-12

Expected to finish

2022-02-04

Last updated by the study team

2023-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Sarasota Memorial Health Care System — Sarasota, Florida, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Harborview Medical Center — Seattle, Washington, United States
• Swedish Medical Center — Seattle, Washington, United States
• University of Washington Medical Center-Montlake — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.