Phase 2
N=17
A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19).
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04425538 ↗Enrolled (actual)
17
Serious AEs
11.8%
Results posted
Dec 2021
Primary outcome: Primary: Time to Improvement in Oxygenation — 4 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Infliximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tufts Medical Center
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Improvement in Oxygenation |
4 | — |
| PRIMARY Number of p[Atients With Improvement in Oxygenation |
15 | — |
| SECONDARY 28-Day Survival Status |
15 | — |
| SECONDARY Duration of Supplemental Oxygen Administration by Nasal Cannula |
3 | — |
| SECONDARY Duration of Non-invasive Ventilation or by Non-rebreather Mask or High-flow Nasal Cannula |
2.5 | — |
| SECONDARY Number of Patients Requiring Mechanical Ventilation |
7 | — |
| SECONDARY Number of Patients Requiring Vasopressor Support |
3 | — |
| SECONDARY Number of Patients Requiring Extracorporeal Membrane Oxygenation |
1 | — |
| SECONDARY Number of Patients With Fever |
12 | — |
| SECONDARY Correlation of Dynamic Changes in IP-10 to Cytokine Profile |
0.652; 0.605; 0.601; 0.585; .571; 0.564 | — |
| SECONDARY Duration of Hospitalization |
8 | — |
| SECONDARY Number of Patients Who Developed Secondary Infections |
7 | — |
| SECONDARY Number of Patients Requiring Supplemental Oxygen Administration by Nasal Cannula |
14 | — |
| SECONDARY Duration of Mechanical Ventilation |
10 | — |
| SECONDARY Number of Patients Requiring Non-invasive Ventilation or by Non-rebreather Mask or High-flow Nasal Cannula |
8 | — |
| SECONDARY Assessment of Cytokine and Inflammatory Profile at Baseline |
109.2; 42.3; 1.46; 69.2; 1972.12 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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) 3% with stable FiO2
Exclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT04425538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.