COVID-19 and Anti-CD14 Treatment Trial

NCT04391309 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: DAIT COVID-19-003NIAID CRMS ID#: 38756UM1AI109565
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 5

Brief Summary

This study aims to address the following objectives:

1. 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. 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. 3.To determine the safety of IC14 in patients hospitalized with respiratory disease due to SARS-CoV-2.

Conditions

Coronavirus Disease 2019 (COVID-19); Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Keywords

anti-CD14 (anti-CD14 chimeric monoclonal antibody); randomized double-blind placebo-controlled clinical trial; hospitalized patients

Outcome Measures

Primary Outcomes (1)

• The Time to Clinical Recovery, Defined as the Time From Baseline to the First Day That Subject is in Categories 1, 2, or 3 on the Eight-Point Ordinal Scale Through Day 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: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care 4. Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care (COVID-19-related or otherwise) 5. Hospitalized, requiring supplemental oxygen 6. Hospitalized, on non-invasive ventilation or high-flow oxygen devices 7. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 8. Death

  Within the 28 day period following baseline

Secondary Outcomes (13)

• Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28

  Within the 28 day period following baseline.

• Change in the Ordinal Scale From Baseline to Day 14

  Within the 14 day period following baseline.

• Change in Ordinal Scale From Baseline to Day 28.

  Within the 28 day period following baseline.

• Ordinal Scale Value on Day 14.

  Day 14 following baseline.

• All-Cause Mortality Through Day 28.

  Within the 28 day period following baseline.

Study Arms (2)

anti-CD14 + SOC

EXPERIMENTAL

Anti-CD14: Anticipated 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; Drug: remdesivir

Placebo + SOC

PLACEBO COMPARATOR

Anticipated 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; Drug: remdesivir

Interventions

anti-CD14 BIOLOGICAL

4 mg/kg on Day 1, 2 mg/kg on Days 2-4 administered intravenously (IV)

Also known as: monoclonal antibody to CD14, IC14

anti-CD14 + SOC

Placebo OTHER

Placebo administered intravenously on Days 1-4

Also known as: Placebo for anti-CD14

Placebo + SOC

remdesivir DRUG

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.

Also known as: Veklury®

Placebo + SOC; anti-CD14 + SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• University of Washington: collaborator
• Implicit Bioscience: collaborator
• Vanderbilt University Medical Center: collaborator
• PPD Development, LP: collaborator

Study Sites (5)

Sarasota Memorial Health Care System

Sarasota, Florida, 34236, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

University of Washington Medical Center-Montlake

Seattle, Washington, 98195, United States

Location

Related Links

• National Institutes of Health News Release Describing Study
• National Institute of Allergy and Infectious Diseases (NIAID)
• NIAID Division of Allergy, Immunology, and Transplantation (DAIT)
• Centers for Disease Control and Prevention -COVID-19 resources

MeSH Terms

Conditions

COVID-19

Interventions

remdesivir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The trial was terminated early because of slow recruitment and cannot be considered fully powered.

Results Point of Contact

• Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

301-594-7669

Study Officials

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo consists of identical-appearing diluent
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 18, 2020
• Study Start: April 12, 2021
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: June 26, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)