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A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19).

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04425538
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
We hypothesize that early institution of TNFα inhibitor therapy in patients with severe COVID-19 infections will prevent further clinical deterioration and reduce the need for advanced cardiorespiratory support and early mortality. To address this hypothesis, a prospective, single center, phase 2 trial is proposed to assess the efficacy of infliximab or infliximab-abda in hospitalized adult patients with severe or critical COVID-19. Observations from this study will inform the conduct of prospective randomized controlled studies to follow.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Infliximab Phase 2

Detailed Description:

We hypothesize that early institution of TNFα inhibitor therapy in patients with severe COVID-19 infections will prevent further clinical deterioration and reduce the need for advanced cardiorespiratory support and early mortality. To address this hypothesis, a prospective, single center, phase 2 trial is proposed to assess the efficacy of infliximab or infliximab-abda in hospitalized adult patients with severe or critical COVID-19. Observations from this study will inform the conduct of prospective randomized controlled studies to follow.

Infliximab and Infliximab-abda are TNFα inhibitors currently FDA-approved for the treatment of autoimmune disorders, including Crohn's disease and rheumatoid arthritis. The risks and adverse reactions are described in the approved prescribing information for infliximab (or infliximab-abda). Infliximab will be used when available. Should infliximab be unavailable in the pharmacy, infliximab-abda, a biosimilar, will be used. For the full prescribing information for infliximab, please click here. Full prescribing information for infliximab-abda can be found here.

Treatment with infliximab or infliximab-abda 5mg/kg IV should ideally be administered within 6 hours of enrollment, and no more than 24 hours following enrollment. Pre-medication with Tylenol 650 mg once 30 minutes prior to infusion would be recommended. Other pre-medications may be given at the discretion of the treating physician. These include diphenhydramine 50mg by mouth, as well as prednisone 20mg by mouth, both given 30 minutes prior to infusion. Pulse and blood pressure should be monitored every 30 minutes during the infusion, and patients should be monitored for at least 30 minutes following the infusion.

Retreatment with infliximab is permitted at treating physician discretion 7-21 days following primary therapy and based on initial response; the usual treatment schedule is every 2 weeks, this interval is not strictly enforced given the uncertainty of outcomes with primary therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19).
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: Infliximab
All patients enrolled into this trial will be assigned to the Infliximab arm. Patients will be treated with infliximab on Day 1, and may be re-treated per protocol and at the discretion of the investigator.
Drug: Infliximab
Either infliximab or infliximab-abda will be used at the discretion of the investigator
Other Name: infliximab-abda




Primary Outcome Measures :
  1. Time to improvement in oxygenation [ Time Frame: 28 Days ]
    Time to improvement in oxygenation


Secondary Outcome Measures :
  1. 28-day mortality [ Time Frame: 28 Days ]
    28-day mortality

  2. Assessment of cytokine and inflammatory profile at baseline and at 48 hours after therapy [ Time Frame: 28 Days ]
    Assessment of cytokine and inflammatory profile at baseline and at 48 hours after therapy

  3. Qualitative and quantitative toxicity [ Time Frame: 28 Days ]
    Qualitative and quantitative toxicity

  4. incidence and duration of supplemental oxygen administration [ Time Frame: 28 Days ]
    incidence and duration of supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device

  5. Incidence and duration of non-invasive ventilation or by non-rebreather mask or high-flow nasal cannula [ Time Frame: 28 Days ]
    Incidence and duration of non-invasive ventilation or by non-rebreather mask or high-flow nasal cannula

  6. Incidence and duration of mechanical ventilation [ Time Frame: 28 Days ]
    Incidence and duration of mechanical ventilation

  7. Incidence and duration of vasopressor support [ Time Frame: 28 Days ]
    Incidence and duration of vasopressor support

  8. Incidence and duration of extracorporeal membrane oxygenation [ Time Frame: 28 Days ]
    Incidence and duration of extracorporeal membrane oxygenation

  9. Duration of fever [ Time Frame: 28 Days ]
    Duration of fever

  10. Correlation of cytokine profile to clinical outcomes specified in primary and secondary objectives [ Time Frame: 28 Days ]
    Correlation of cytokine profile to clinical outcomes specified in primary and secondary objectives

  11. Duration of hospitalization [ Time Frame: 28 Days ]
    Duration of hospitalization

  12. Secondary infections [ Time Frame: 28 Days ]
    Secondary infections



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Age 18 years or older
  2. Able to provide informed consent
  3. Hospitalized adult patients with pneumonia evidenced by chest X-ray or CT scan
  4. Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending
  5. And at least one of the following:

    1. Respiratory frequency ≥30/min
    2. Blood oxygen saturation ≤93% on RA
    3. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) <300
    4. Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of >3% with stable FiO2

Exclusion Criteria:

  1. Treatment with any TNFα inhibitor in the past 30 days
  2. Known hypersensitivity to any TNFα inhibitor, murine proteins, or any component of the formulation
  3. Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 1000 mm3, hemoglobin <8.0g/L, platelets <50,000 per mm3, or AST or ALT greater than 5 x ULN
  4. Known active or latent Hepatitis B
  5. Known or suspected active tuberculosis (TB) or a history of incompletely treated or latent TB.
  6. Pregnancy
  7. Intubated for >48hours
  8. Patients with uncontrolled systemic bacterial or fungal infections (Patients with a history of positive bacterial or fungal cultures but on enrollment are on appropriate therapy with negative repeat cultures may be enrolled)
  9. Serious co-morbidity, including:

    1. Myocardial infarction (within last month)
    2. Moderate or severe heart failure (New York Heart Association (NYHA) class III or IV)
    3. Acute stroke (within last month)
    4. Uncontrolled malignancy
    5. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30 ml /min/1.73 m^2) at baseline

Information from the National Library of Medicine

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): NCT04425538


Contacts
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Contact: Christian Lawlor 617-636-5000 ext 8897 clawlor3@tuftsmedicalcenter.org
Contact: Jaime Chisholm jchisholm@tuftsmedicalcenter.org

Locations
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United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Paul Mathew, MD    617-636-5000 ext 2694    pmathew@tuftsmedicalcenter.org   
Sponsors and Collaborators
Tufts Medical Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Paul Mathew, MD Tufts Medical Center
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT04425538    
Other Study ID Numbers: STUDY00000564
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tufts Medical Center:
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents