COVID-19 and Anti-CD14 Treatment Trial (CaTT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04391309 |
Recruitment Status :
Terminated
(Stopped to slow rate of enrollment)
First Posted : May 18, 2020
Last Update Posted : April 1, 2022
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This study aims to address the following objectives:
- 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.
- To determine the efficacy of IC14 in reducing the severity of respiratory disease in patients hospitalized with respiratory disease due to SARS-CoV-2.
- To determine the safety of IC14 in patients hospitalized with respiratory disease due to SARS-CoV-2.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronavirus Disease 2019 (COVID-19) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | Biological: anti-CD14 Other: Placebo Drug: remdesivir | Phase 2 |
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-19) patients.
Participants will be randomized to IC14 or matching placebo and followed for 60 days after randomization. The study drug will be administered daily on Days 1-4 by intravenous infusion. All participants will receive standard of care antiviral therapy with remdesivir.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized, Double-Blind, Placebo-Controlled |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Placebo consists of identical-appearing diluent |
Primary Purpose: | Treatment |
Official Title: | Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Anti-CD14 Treatment in Hospitalized Patients With COVID-19 |
Actual Study Start Date : | April 12, 2021 |
Actual Primary Completion Date : | February 4, 2022 |
Actual Study Completion Date : | February 4, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: anti-CD14 + SOC
Anti-CD14: 150 participants randomized to 4 mg/kg on Day 1, 2 mg/kg on Days 2-4 intravenously. Standard of Care (SOC): All participants will receive remdesivir (antiviral) according to current approved dosing for COVID-19 illness. |
Biological: anti-CD14
4 mg/kg on Day 1, 2 mg/kg on Days 2-4 administered intravenously (IV)
Other Names:
Drug: remdesivir Remdesivir administered intravenously for 5 days beginning with a 200 mg loading dose on Day 1, followed by 100 mg/day on Days 2-5.
Other Name: Veklury® |
Placebo Comparator: Placebo + SOC
150 participants randomized to Placebo diluent on Days 1-4 intravenously. Standard of Care (SOC): All participants will receive remdesivir (antiviral) according to current approved dosing for COVID-19 illness. |
Other: Placebo
Placebo administered intravenously on Days 1-4
Other Name: Placebo for anti-CD14 Drug: remdesivir Remdesivir administered intravenously for 5 days beginning with a 200 mg loading dose on Day 1, followed by 100 mg/day on Days 2-5.
Other Name: Veklury® |
- Time to Clinical Recovery [ Time Frame: Day 0-28 ]
The Primary Endpoint is time to clinical recovery, defined as the time from baseline to the first day that a subject is in categories 1, 2, or 3 on the Eight-Point Ordinal Scale through Day 28 (range 1 [best] to 8 [worst]). The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day. The Scale is defined as follows:
- Not hospitalized, no limitations on activities
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care
- Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care (COVID-19-related or otherwise)
- Hospitalized, requiring supplemental oxygen
- Hospitalized, on non-invasive ventilation or high-flow oxygen devices
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Death
- Days Alive and Free of Any Episodes of Acute Respiratory Failure through Day 28 [ Time Frame: Days 0-28 ]
Defined by need for any of the following oxygen delivery resources:
- High-flow nasal cannula (flow rates ≥30L/min with FiO2 ≥0.4)
- Noninvasive positive-pressure ventilation through nasal or face mask, or nasal plugs
- Endotracheal intubation and mechanical ventilation
- Extracorporeal membrane oxygenation
- Mean Change in the Ordinal Scale (Range 1 [Best] to 8 [Worst]) [ Time Frame: Days 0-14 and Days 0-28 ]Ordinal scale as defined above
- Ordinal Scale Value on Day 14 (Range 1 [Best] to 8 [Worst]) [ Time Frame: Day 14 ]Ordinal scale as defined above
- All-Cause Mortality through Days 28 and 60 [ Time Frame: Days 0-28 and Days 0-60 ]Mortality due to all causes during the observation period
- Proportion of Participants Alive and Free of Any Episode of Acute Respiratory Failure through Day 28 [ Time Frame: Days 0-28 ]
Defined by need for any of the following oxygen delivery resources:
- High-flow nasal cannula (flow rates ≥30L/min with FiO2 ≥0.4)
- Noninvasive positive-pressure ventilation
- Endotracheal intubation and mechanical ventilation
- Extracorporeal membrane oxygenation
- Days Alive and Free of Invasive Mechanical Ventilation through Day 28 [ Time Frame: Days 0-28 ]Invasive mechanical ventilation defined above
- Proportion of Participants Alive and Free of Invasive Mechanical Ventilation through Day 28 [ Time Frame: Days 0-28 ]Invasive mechanical ventilation defined above
- Proportion of Participants Alive and Discharged from the Hospital through Day 28 [ Time Frame: Days 0-28 ]Discharged from hospital and alive
- Proportion of Participants who Begin Corticosteroid Therapy for Worsening COVID-19 Illness after Randomization [ Time Frame: Days 0-28 ]Initiation of systemic corticosteroid therapy
- Serious Adverse Events (SAEs) [ Time Frame: Days 0-28 ]Cumulative incidence of serious adverse events
- Adverse Events (AEs) [ Time Frame: Days 0-28 ]Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events
- Safety of IC14 as Measured by Change from Baseline in ALT and AST Liver Function Tests [ Time Frame: Days 0-28 ]
Serum liver function tests, hepatic/metabolic biomarkers:
- serum alanine aminotransferase (ALT/SGPT), and
- serum aspartate aminotransferase (AST/SGOT)
Unit of Measure: U/L
- Safety of IC14 as Measured by Change from Baseline in Liver Function Measured by Total Bilirubin [ Time Frame: Days 0-28 ]
Serum total bilirubin, an hepatic/metabolic biomarker.
Unit of Measure: mg/dL
- Safety of IC14 as Measured by Change from Baseline in Serum Creatinine [ Time Frame: Days 0-28 ]
Evaluation of kidney function by serum creatinine laboratory test.
Unit of Measure mg/dL
- Safety of IC14 as Measured by Change from Baseline in Hemoglobin [ Time Frame: Days 0-28 ]A hematologic measure (g/dL).
- Safety of IC14 as Measured by Change from Baseline in White Blood Cell Count [ Time Frame: Days 0-28 ]
Hematologic measure: White Blood Cell (WBC) count.
Unit of Measure: 1.0x10^3/mcL.
- Safety of IC14 as Measured by Change from Baseline in Differential White Blood Count [ Time Frame: Days 0-28 ]
Hematology parameters: differential white blood cells (WBC) count (neutrophils, lymphocytes, monocytes, eosinophil's, and basophils).
Unit of measure (absolute): K/mcL
- Safety of IC14 as Measured by Change from Baseline in Platelet Count [ Time Frame: Days 0-28 ]
Hematologic/coagulation parameter.
Unit of Measure: 1.0x10^3/mcL
- Safety of IC14 as Measured by Change from Baseline in Prothrombin Time [ Time Frame: Days 0-28 ]Coagulation function. Unit of measure: seconds
- EXPLORATORY: Change in Sequential Organ Failure Assessment (SOFA) Score from Baseline to Days 7, 14, 21 and 28 [ Time Frame: Days 0-7, Days 0-14, Days 0-21, and Days 0-28 ]Sequential Organ Failure Assessment score (range 0 [best] to 24 [worst])
- EXPLORATORY: Worst SOFA Score from Baseline to Day 28 [ Time Frame: Days 0-28 ]Sequential Organ Failure Assessment score (range 0 [best] to 24 [worst])
- EXPLORATORY: Time from Baseline to Improvement in One Category Using an Ordinal Scale through Day 28 [ Time Frame: Days 0-28 ]Ordinal scale defined above (range 1 [best] to 8 [worst])
- EXPLORATORY: Time from Baseline to Improvement in Two Categories Using an Ordinal Scale through Day 28 [ Time Frame: Days 0-28 ]Ordinal scale defined above (range 1 [best] to 8 [worst])
- EXPLORATORY: Proportion of Participants with Negative Nasal Swabs for SARS CoV2 Virus [ Time Frame: Up to Day 14 ]Nasal swab culture for SARS COV2
- EXPLORATORY: Change from Baseline in Pro-Inflammatory Cytokines [ Time Frame: Days 0, 4, 7, 14 and 21 ]
Pro-inflammatory cytokines are involved in the up-regulation of inflammatory reactions.
Exploratory blood serum samples evaluated by ELISA assay, will include the following:
- Tumor Necrosis Factor-alpha (TNF-α),
- Interleukin-1 beta (IL-1B),
- Interleukin-6 (IL-6),
- Interleukin-8 (IL-8),
- Interleukin-10 (IL-10), and
- granulocyte-macrophage colony-stimulating factor (GM-CSF)
Unit of Measure: pg/mL
- EXPLORATORY: Change from Baseline in C-Reactive Protein (CRP) [ Time Frame: Days 0, 4, 7, 14 and 21 ]
An inflammatory biomarker.
Unit of Measure: mg/L
- EXPLORATORY: Change from Baseline in Ferritin [ Time Frame: Days 0, 4, 7, 14 and 21 ]
An inflammatory biomarker.
Unit of Measure: mcg/L
- EXPLORATORY: Change from Baseline in Lactate Dehydrogenase (LDH) [ Time Frame: Days 0, 4, 7, 14 and 21 ]
An inflammatory biomarker.
Unit of Measure:U/L

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391309
United States, California | |
Harbor - UCLA Medical Center | |
Torrance, California, United States, 90502 | |
United States, Florida | |
University of Miami Medical Center | |
Miami Beach, Florida, United States, 33136 | |
Sarasota Memorial Health Care System | |
Sarasota, Florida, United States, 34236 | |
United States, Georgia | |
Emory University Medical Center | |
Atlanta, Georgia, United States, 30322 | |
United States, Louisiana | |
Ochsner Health | |
New Orleans, Louisiana, United States, 70121 | |
United States, Maryland | |
University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Baystate Medical Center | |
Springfield, Massachusetts, United States, 01199 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Thomas Jefferson University Hospital | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Washington | |
Virginia Mason Medical Center | |
Seattle, Washington, United States, 98101 | |
Harborview Medical Center | |
Seattle, Washington, United States, 98104 | |
Swedish Medical Center | |
Seattle, Washington, United States, 98122 | |
University of Washington Medical Center-Montlake | |
Seattle, Washington, United States, 98195 | |
University of Washington Medical Center | |
Seattle, Washington, United States, 98195 |
Study Chair: | Mark M. Wurfel, MD, PhD | University of Washington: Division of Pulmonary, Critical Care and Sleep Medicine | |
Study Chair: | Thomas R. Martin, MD | University of Washington: Division of Pulmonary, Critical Care and Sleep Medicine |
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT04391309 |
Other Study ID Numbers: |
DAIT COVID-19-003 NIAID CRMS ID#: 38756 ( Other Identifier: DAIT NIAID ) UM1AI109565 ( U.S. NIH Grant/Contract ) |
First Posted: | May 18, 2020 Key Record Dates |
Last Update Posted: | April 1, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
anti-CD14 (anti-CD14 chimeric monoclonal antibody) randomized double-blind placebo-controlled clinical trial hospitalized patients |
COVID-19 Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Remdesivir Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |