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

• Status: Completed
• Trial end date: 2021-01-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Collaborator: National Institutes of Health (NIH)
• Treatments: Infliximab

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