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Coronavirus Disease 2019 (COVID-19)Phase 2CaTTNCT04391309

COVID-19 and Anti-CD14 Treatment Trial

A Phase 2 study testing anti-CD14 and remdesivir in people with Coronavirus Disease 2019 (COVID-19) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
anti-CD14 and remdesivir
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
5 sitesUnited States
Study dates
12 Apr 2021to 4 Feb 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 29Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34236

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Medical Center

    Seattle, Washington, 98122

  • University of Washington Medical Center-Montlake

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Anti-CD14 Treatment in Hospitalized Patients With COVID-19

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.
Read the 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-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.

Being tested
anti-CD14, Placebo, remdesivir
Keywords
anti-CD14 (anti-CD14 chimeric monoclonal antibody), randomized double-blind placebo-controlled clinical trial, hospitalized patients
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-CD14Biological

    Also called monoclonal antibody to CD14, IC14

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

  • PlaceboOther

    Also called Placebo for anti-CD14

    Placebo administered intravenously on Days 1-4

  • remdesivirDrug

    Also called Veklury®

    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.

Study groups in NCT04391309
Study groupRoleWhat they receive
anti-CD14 + SOCExperimentalAnti-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.
Receives: Biological: anti-CD14; Drug: remdesivir
Placebo + SOCPlacebo comparatorAnticipated 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.
Receives: Other: Placebo; Drug: remdesivir

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Within the 28 day period following baseline

Secondary outcomes (13)

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

    Episodes of acute respiratory failure are defined as by need for the following oxygen delivery resources:

    1. High-flow nasal cannula (flow rates ≥30L/min with FiO2 ≥0.4)
    2. Noninvasive positive-pressure ventilation through nasal or face mask, or nasal plugs
    3. Endotracheal intubation and mechanical
    4. Extracorporeal membrane oxygenation

    Measured: Within the 28 day period following baseline.

  2. Change in the Ordinal Scale From Baseline to Day 14

    A larger negative change indicates a greater improvement in clinical status from baseline. The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day (1 is best, 8 is worst). 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.

    Measured: Within the 14 day period following baseline.

  3. Change in Ordinal Scale From Baseline to Day 28.

    A larger negative change indicates a greater improvement in clinical status from baseline. The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day (1 is best, 8 is worst). 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.

    Measured: Within the 28 day period following baseline.

  4. Ordinal Scale Value on Day 14.

    The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day (1 is best, 8 is worst). 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.

    Measured: Day 14 following baseline.

  5. All-Cause Mortality Through Day 28.

    Mortality due to all causes during the observation period.

    Measured: Within the 28 day period following baseline.

  6. All-Cause Mortality Through Day 60.

    Mortality due to all causes during the observation period.

    Measured: Within the 60 day period following baseline.

  7. Percentage of Participants Alive and Free of Any Episode of Acute Respiratory Failure Through Day 28

    Episodes of acute respiratory failure are defined as by need for the following oxygen delivery resources:

    1. High-flow nasal cannula (flow rates ≥30L/min with FiO2 ≥0.4)
    2. Noninvasive positive-pressure ventilation through nasal or face mask, or nasal plugs
    3. Endotracheal intubation and mechanical ventilation
    4. Extracorporeal membrane oxygenation

    Measured: Within the 28 day period following baseline.

  8. Days Alive and Free of Invasive Mechanical Ventilation Through Day 28

    Endotracheal intubation and mechanical ventilation.

    Measured: Within the 28 day period following baseline.

  9. Percentage of Participants Alive and Free of Invasive Mechanical Ventilation Through Day 28

    Endotracheal intubation and mechanical ventilation.

    Measured: Within the 28 day period following baseline.

  10. Percentage of Participants Alive and Discharged From the Hospital Through Day 28

    Participants must be alive and discharged from hospital.

    Measured: Within the 28 day period following baseline.

  11. Percent of Participants Who Begin Corticosteroid Therapy for Worsening COVID-19 Illness After Randomization

    Initiation of corticosteroid therapy.

    Measured: Within the 28 day period following baseline.

  12. Serious Adverse Events (SAEs)

    Number of serious adverse events

    Measured: Within the 28 day period following baseline.

  13. Adverse Events (AEs)

    Number of Grade 3 and 4 clinical and/or laboratory adverse events

    Measured: Within the 28 day period following baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2020
  2. Study start12 Apr 2021
  3. Primary completion4 Feb 2022
  4. Study completion4 Feb 2022

Why it stopped: Stopped to slow rate of enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-Blind, Placebo-Controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04391309
Sponsor's protocol ID
DAIT COVID-19-003
Other IDs
NIAID CRMS ID#: 38756, UM1AI109565
Acronym
CaTT
Status last verified
Jun 2023
First submitted
14 May 2020
Last updated
26 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-CD14 and remdesivir in people with Coronavirus Disease 2019 (COVID-19) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Within the 28 day period following baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04391309.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.

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