A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19).
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|ClinicalTrials.gov Identifier: NCT04425538|
Recruitment Status : Completed
First Posted : June 11, 2020
Last Update Posted : February 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Infliximab||Phase 2|
The investigators 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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19).|
|Actual Study Start Date :||June 1, 2020|
|Actual Primary Completion Date :||January 22, 2021|
|Actual Study Completion Date :||January 22, 2021|
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.
Either infliximab or infliximab-abda will be used at the discretion of the investigator
Other Name: infliximab-abda
- Time to improvement in oxygenation [ Time Frame: 28 Days ]Time to improvement in oxygenation (increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2) sustained for a minimum of 48 hours
- 28-day mortality [ Time Frame: 28 Days ]28-day mortality
- 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 (TNFα, IL-1b, IL-2, sIL-2r, IL-6, ferritin, ESR, CRP, CPK, troponin) after therapy
- Qualitative and quantitative toxicity [ Time Frame: 28 Days ]Qualitative and quantitative toxicity
- 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
- 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
- Incidence and duration of mechanical ventilation [ Time Frame: 28 Days ]Incidence and duration of mechanical ventilation
- Incidence and duration of vasopressor support [ Time Frame: 28 Days ]Incidence and duration of vasopressor support
- Incidence and duration of extracorporeal membrane oxygenation [ Time Frame: 28 Days ]Incidence and duration of extracorporeal membrane oxygenation
- Duration of fever [ Time Frame: 28 Days ]Duration of fever
- 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
- Duration of hospitalization [ Time Frame: 28 Days ]Duration of hospitalization
- Secondary infections [ Time Frame: 28 Days ]Secondary infections
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
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Paul Mathew, MD||Tufts Medical Center|