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COVID-19 and Anti-CD14 Treatment Trial

NCT04391309 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2023-06-26

Study results available
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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 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.

Conditions

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

Interventions

BIOLOGICAL

anti-CD14

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

OTHER

Placebo

Placebo administered intravenously on Days 1-4

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.

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • Implicit Bioscience

    collaborator INDUSTRY

  • Vanderbilt University Medical Center

    collaborator OTHER

  • PPD Development, LP

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Mark M. Wurfel, MD, PhD · University of Washington: Division of Pulmonary, Critical Care and Sleep Medicine

  • Thomas R. Martin, MD · University of Washington: Division of Pulmonary, Critical Care and Sleep Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2022-02-04
Completion
2022-02-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04391309 on ClinicalTrials.gov