Status:
COMPLETED
A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19).
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Able to provide informed consent
- Hospitalized adult patients with pneumonia evidenced by chest X-ray or CT scan
- Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending
- And at least one of the following:
- Respiratory frequency ≥30/min
- Blood oxygen saturation ≤93% on RA
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) \<300
- 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
- Treatment with any TNFα inhibitor in the past 30 days
- Known hypersensitivity to any TNFα inhibitor, murine proteins, or any component of the formulation
- 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
- Known active or latent Hepatitis B
- Known or suspected active tuberculosis (TB) or a history of incompletely treated or latent TB.
- Pregnancy
- Intubated for \>48hours
- 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)
- Serious co-morbidity, including:
- Myocardial infarction (within last month)
- Moderate or severe heart failure (New York Heart Association (NYHA) class III or IV)
- Acute stroke (within last month)
- Uncontrolled malignancy
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04425538
Start Date
June 1 2020
End Date
January 22 2021
Last Update
April 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111