Trial Outcomes & Findings for A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19). (NCT NCT04425538)

NCT ID: NCT04425538

Last Updated: 2022-04-20

Results Overview

Time to improvement in oxygenation (increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 28 Days
• Results posted on: 2022-04-20

Participant Flow

Participant milestones

Measure	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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Age, Customized 18-40 years	1 Participants n=5 Participants
Age, Customized 41-60 years	7 Participants n=5 Participants
Age, Customized >60 years	9 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	4 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	3 Participants n=5 Participants
Race/Ethnicity, Customized Other Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 Days

Population: 15 patients met this endpoint whereby duration data could be obtained

Time to improvement in oxygenation (increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2)

Outcome measures

Measure	Infliximab n=15 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Time to Improvement in Oxygenation	4 Days Interval 1.0 to 12.0

PRIMARY outcome

Timeframe: 28 Days

Number of participants who showed improvement in oxygenation (increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2)

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Number of p[Atients With Improvement in Oxygenation	15 Participants

SECONDARY outcome

Timeframe: 28 Days

Number of patients who were confirmed to be alive 28 days from enrollment onto the study.

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
28-Day Survival Status	15 Participants

SECONDARY outcome

Timeframe: 28 Days

Duration of supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Duration of Supplemental Oxygen Administration by Nasal Cannula	3 Days Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 28 Days

Duration of non-invasive ventilation or by non-rebreather mask or high-flow nasal cannula

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Duration of Non-invasive Ventilation or by Non-rebreather Mask or High-flow Nasal Cannula	2.5 Days Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: 28 Days

Number of patients enrolled who required mechanical ventilation

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Number of Patients Requiring Mechanical Ventilation	7 Participants

SECONDARY outcome

Timeframe: 28 Days

Number of participants who required vasopressor support

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Number of Patients Requiring Vasopressor Support	3 Participants

SECONDARY outcome

Timeframe: 28 Days

Number of patients requiring extracorporeal membrane oxygenation

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Number of Patients Requiring Extracorporeal Membrane Oxygenation	1 Participants

SECONDARY outcome

Timeframe: 28 Days

Number of patients who exhibited fever during the study period

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Number of Patients With Fever	12 Participants

SECONDARY outcome

Timeframe: 3 Days

Correlation of dynamic changes in IP-10 to cytokine profile between day 3 and baseline

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Correlation of Dynamic Changes in IP-10 to Cytokine Profile CXCL9	0.652 Correlation coefficient
Correlation of Dynamic Changes in IP-10 to Cytokine Profile IL-15	0.605 Correlation coefficient
Correlation of Dynamic Changes in IP-10 to Cytokine Profile FLT-3L	0.601 Correlation coefficient
Correlation of Dynamic Changes in IP-10 to Cytokine Profile IL-12p40	0.585 Correlation coefficient
Correlation of Dynamic Changes in IP-10 to Cytokine Profile IL-3	.571 Correlation coefficient
Correlation of Dynamic Changes in IP-10 to Cytokine Profile M-CSF	0.564 Correlation coefficient
Correlation of Dynamic Changes in IP-10 to Cytokine Profile MDC	0.528 Correlation coefficient
Correlation of Dynamic Changes in IP-10 to Cytokine Profile IFN-A2	0.509 Correlation coefficient
Correlation of Dynamic Changes in IP-10 to Cytokine Profile IL-5	.501 Correlation coefficient
Correlation of Dynamic Changes in IP-10 to Cytokine Profile IL-18	.484 Correlation coefficient

SECONDARY outcome

Timeframe: 28 Days

Duration of hospitalization

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Duration of Hospitalization	8 days Interval 1.0 to 28.0

SECONDARY outcome

Timeframe: 28 Days

Number of patients who developed secondary infections

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Number of Patients Who Developed Secondary Infections	7 Participants

SECONDARY outcome

Timeframe: 28 Days

Incidence of supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Number of Patients Requiring Supplemental Oxygen Administration by Nasal Cannula	14 Participants

SECONDARY outcome

Timeframe: 28 Days

Population: 7 of 17 enrolled patients required mechanical ventilation

duration of use of mechanical ventilation (for patients requiring mechanical ventilation)

Outcome measures

Measure	Infliximab n=7 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Duration of Mechanical Ventilation	10 days Interval 5.0 to 28.0

SECONDARY outcome

Timeframe: 28 Days

Number of participants who required non-invasive ventilation or by non-rebreather mask or high-flow nasal cannula

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Number of Patients Requiring Non-invasive Ventilation or by Non-rebreather Mask or High-flow Nasal Cannula	8 Participants

SECONDARY outcome

Timeframe: Baseline

Assessment of cytokine and inflammatory profile at baseline (TNFα, IL-1b, IL-2, IL-6, ferritin) after therapy

Outcome measures

Measure	Infliximab n=17 Participants 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Assessment of Cytokine and Inflammatory Profile at Baseline TNFα	109.2 ng/mL Standard Deviation 53.4
Assessment of Cytokine and Inflammatory Profile at Baseline IL-1β	42.3 ng/mL Standard Deviation 97.8
Assessment of Cytokine and Inflammatory Profile at Baseline IL-2	1.46 ng/mL Standard Deviation 2.21
Assessment of Cytokine and Inflammatory Profile at Baseline IL-6	69.2 ng/mL Standard Deviation 130.85
Assessment of Cytokine and Inflammatory Profile at Baseline Ferritin	1972.12 ng/mL Standard Deviation 1517.56

Adverse Events

Infliximab

Serious events: 2 serious events

Other events: 16 other events

Deaths: 2 deaths

Serious adverse events

Measure	Infliximab n=17 participants at risk 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Cardiac disorders Cardiac Arrest	5.9% 1/17 • Number of events 1 • Adverse events and serious adverse events were collected for each patient beginning at the time of first infliximab dose through 28 days following the last dose of infliximab. Study-wide, adverse event collection was conducted for approximately 8 months. Serious adverse events and all-cause mortality were collected according to clinicaltrials.gov definitions. For other adverse events, only adverse events of special interest were collected for the purposes of this trial. Adverse events of special interest include infusion reactions from infliximab treatment, anaphylaxis, and any other event deemed by the investigator to be directly related to infliximab treatment.
Infections and infestations Covid-Associated Pulmonary Aspergillosis	5.9% 1/17 • Number of events 1 • Adverse events and serious adverse events were collected for each patient beginning at the time of first infliximab dose through 28 days following the last dose of infliximab. Study-wide, adverse event collection was conducted for approximately 8 months. Serious adverse events and all-cause mortality were collected according to clinicaltrials.gov definitions. For other adverse events, only adverse events of special interest were collected for the purposes of this trial. Adverse events of special interest include infusion reactions from infliximab treatment, anaphylaxis, and any other event deemed by the investigator to be directly related to infliximab treatment.

Other adverse events

Measure	Infliximab n=17 participants at risk 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. Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator
Investigations AST Elevation	52.9% 9/17 • Adverse events and serious adverse events were collected for each patient beginning at the time of first infliximab dose through 28 days following the last dose of infliximab. Study-wide, adverse event collection was conducted for approximately 8 months. Serious adverse events and all-cause mortality were collected according to clinicaltrials.gov definitions. For other adverse events, only adverse events of special interest were collected for the purposes of this trial. Adverse events of special interest include infusion reactions from infliximab treatment, anaphylaxis, and any other event deemed by the investigator to be directly related to infliximab treatment.
Investigations ALT Elevation	47.1% 8/17 • Adverse events and serious adverse events were collected for each patient beginning at the time of first infliximab dose through 28 days following the last dose of infliximab. Study-wide, adverse event collection was conducted for approximately 8 months. Serious adverse events and all-cause mortality were collected according to clinicaltrials.gov definitions. For other adverse events, only adverse events of special interest were collected for the purposes of this trial. Adverse events of special interest include infusion reactions from infliximab treatment, anaphylaxis, and any other event deemed by the investigator to be directly related to infliximab treatment.
General disorders Acute Infusion Reaction	11.8% 2/17 • Adverse events and serious adverse events were collected for each patient beginning at the time of first infliximab dose through 28 days following the last dose of infliximab. Study-wide, adverse event collection was conducted for approximately 8 months. Serious adverse events and all-cause mortality were collected according to clinicaltrials.gov definitions. For other adverse events, only adverse events of special interest were collected for the purposes of this trial. Adverse events of special interest include infusion reactions from infliximab treatment, anaphylaxis, and any other event deemed by the investigator to be directly related to infliximab treatment.
Infections and infestations Lung Infection	47.1% 8/17 • Adverse events and serious adverse events were collected for each patient beginning at the time of first infliximab dose through 28 days following the last dose of infliximab. Study-wide, adverse event collection was conducted for approximately 8 months. Serious adverse events and all-cause mortality were collected according to clinicaltrials.gov definitions. For other adverse events, only adverse events of special interest were collected for the purposes of this trial. Adverse events of special interest include infusion reactions from infliximab treatment, anaphylaxis, and any other event deemed by the investigator to be directly related to infliximab treatment.
Investigations Hyperglycemia	5.9% 1/17 • Adverse events and serious adverse events were collected for each patient beginning at the time of first infliximab dose through 28 days following the last dose of infliximab. Study-wide, adverse event collection was conducted for approximately 8 months. Serious adverse events and all-cause mortality were collected according to clinicaltrials.gov definitions. For other adverse events, only adverse events of special interest were collected for the purposes of this trial. Adverse events of special interest include infusion reactions from infliximab treatment, anaphylaxis, and any other event deemed by the investigator to be directly related to infliximab treatment.
Renal and urinary disorders Acute Kidney Injury	17.6% 3/17 • Adverse events and serious adverse events were collected for each patient beginning at the time of first infliximab dose through 28 days following the last dose of infliximab. Study-wide, adverse event collection was conducted for approximately 8 months. Serious adverse events and all-cause mortality were collected according to clinicaltrials.gov definitions. For other adverse events, only adverse events of special interest were collected for the purposes of this trial. Adverse events of special interest include infusion reactions from infliximab treatment, anaphylaxis, and any other event deemed by the investigator to be directly related to infliximab treatment.
Infections and infestations Herpes Simplex Reactivation	11.8% 2/17 • Adverse events and serious adverse events were collected for each patient beginning at the time of first infliximab dose through 28 days following the last dose of infliximab. Study-wide, adverse event collection was conducted for approximately 8 months. Serious adverse events and all-cause mortality were collected according to clinicaltrials.gov definitions. For other adverse events, only adverse events of special interest were collected for the purposes of this trial. Adverse events of special interest include infusion reactions from infliximab treatment, anaphylaxis, and any other event deemed by the investigator to be directly related to infliximab treatment.
Cardiac disorders Atrial Fibrillation	5.9% 1/17 • Adverse events and serious adverse events were collected for each patient beginning at the time of first infliximab dose through 28 days following the last dose of infliximab. Study-wide, adverse event collection was conducted for approximately 8 months. Serious adverse events and all-cause mortality were collected according to clinicaltrials.gov definitions. For other adverse events, only adverse events of special interest were collected for the purposes of this trial. Adverse events of special interest include infusion reactions from infliximab treatment, anaphylaxis, and any other event deemed by the investigator to be directly related to infliximab treatment.
Cardiac disorders Intermittent Sinus Bradycardia	5.9% 1/17 • Adverse events and serious adverse events were collected for each patient beginning at the time of first infliximab dose through 28 days following the last dose of infliximab. Study-wide, adverse event collection was conducted for approximately 8 months. Serious adverse events and all-cause mortality were collected according to clinicaltrials.gov definitions. For other adverse events, only adverse events of special interest were collected for the purposes of this trial. Adverse events of special interest include infusion reactions from infliximab treatment, anaphylaxis, and any other event deemed by the investigator to be directly related to infliximab treatment.

Additional Information

Director of Clinical Trials

Neely Center for Clinical Research, Tufts Medical Center

Phone: 617-636-5000

Email: ncccr@tuftsmedicalcenter.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place