Trial Outcomes & Findings for Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19) (NCT NCT04348500)

NCT ID: NCT04348500

Last Updated: 2024-02-08

Results Overview

Number of severe adverse events (SAEs) that are unusual, unexpected, or assessed as related to the investigational product (IP)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2024-02-08

Participant Flow

Patients eligible for the study and who may benefit from the administration of clazakizumab will be identified by members of the inpatient team and referred to the study team. If a patient is eligible, the PI or Co-I will discuss the study with them. Treating physicians of COVID-19 patients will be made aware of the research offering. Patients will be asked if they can be approached about research options. Researchers may approach potential subjects who indicate they are interested.

Of the total 105 participants ages 18 years and older screened, 17 were enrolled in this single center, randomized, double-blind, placebo-controlled, exploratory phase II study.

Participant milestones

Measure	Clazakizumab 25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Placebo 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
Overall Study STARTED	8	9
Overall Study Treated	8	8
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Clazakizumab 25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Placebo 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
Overall Study Death	2	2
Overall Study Withdrawn by subject due to dementia	0	1

Baseline Characteristics

Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19)

Baseline characteristics by cohort

Measure	Clazakizumab n=8 Participants 25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Placebo n=8 Participants 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	59 years STANDARD_DEVIATION 13.44 • n=5 Participants	60 years STANDARD_DEVIATION 13.14 • n=7 Participants	59 years STANDARD_DEVIATION 13.86 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Enrolled patients who received the initial dose of the IP were analyzed.

Number of severe adverse events (SAEs) that are unusual, unexpected, or assessed as related to the investigational product (IP)

Outcome measures

Measure	Clazakizumab n=8 Participants 25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Placebo n=8 Participants 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
Safety of Clazakizumab for the Treatment of Patients With COVID-19 Disease SAEs within 14 days	3 Adverse Events	3 Adverse Events
Safety of Clazakizumab for the Treatment of Patients With COVID-19 Disease Adverse Events (AEs) and SAEs overall	6 Adverse Events	8 Adverse Events

SECONDARY outcome

Timeframe: 28 days

Population: Enrolled patients who received the initial dose of the IP were analyzed.

Number of patients alive at 28 days

Outcome measures

Measure	Clazakizumab n=8 Participants 25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Placebo n=8 Participants 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
Patient Survival at 28 Days	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 60 days

Population: Enrolled patients who received the initial dose of the IP were analyzed.

Number of patients alive at 60 days

Outcome measures

Measure	Clazakizumab n=8 Participants 25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Placebo n=8 Participants 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
Patient Survival at 60 Days	6 Participants	6 Participants

SECONDARY outcome

Timeframe: 14 days

Population: Enrolled patients who received the initial dose of the IP were analyzed.

Number of patients requiring the dose of open-label clazakizumab

Outcome measures

Measure	Clazakizumab n=8 Participants 25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Placebo n=8 Participants 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
Number of Patients Requiring the Dose of Open-label Clazakizumab	2 Participants	5 Participants

SECONDARY outcome

Timeframe: 60 days

Population: Enrolled patients who received the initial dose of the IP were analyzed.

Number of days in ICU compared to placebo

Outcome measures

Measure	Clazakizumab n=8 Participants 25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Placebo n=8 Participants 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
Number of Days in Intensive Care Unit (ICU)	30.5 Days Standard Deviation 34.65	11.67 Days Standard Deviation 3.06

SECONDARY outcome

Timeframe: 60 days

Population: Enrolled patients who received the initial dose of the IP were analyzed.

Number of days in hospital compared to placebo

Outcome measures

Measure	Clazakizumab n=8 Participants 25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Placebo n=8 Participants 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
Number of Days in Hospital	17.5 Days Standard Deviation 16.62	18.75 Days Standard Deviation 13.60

SECONDARY outcome

Timeframe: 14 days

Population: Enrolled patients who received the initial dose of the IP were analyzed.

Number of patients requiring mechanical ventilation and/or ECMO at 14 days after the first administered dose in comparison to placebo

Outcome measures

Measure	Clazakizumab n=8 Participants 25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Placebo n=8 Participants 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
Number of Patients Requiring Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO)	1 Participants	2 Participants

Adverse Events

Clazakizumab

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Placebo

Serious events: 3 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Measure	Clazakizumab n=8 participants at risk 25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Placebo n=8 participants at risk 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
Infections and infestations Candida parapsilosis Fungemia	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
General disorders Death	25.0% 2/8 • Number of events 2 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	25.0% 2/8 • Number of events 2 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxic Respiratory Failure	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
Infections and infestations Multidrug-Resistant (MDR) Pseudomonas	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
Cardiac disorders Pulseless Electrical Activity (PEA) Event	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
Injury, poisoning and procedural complications T12 Compression Fracture Secondary to Fall	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
General disorders Worsening Hypoxia	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
Renal and urinary disorders Worsening Kidney Function	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.

Other adverse events

Measure	Clazakizumab n=8 participants at risk 25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes	Placebo n=8 participants at risk 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
Renal and urinary disorders Acute Kidney Injury (AKI)	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
Nervous system disorders Delirium, multifactorial	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
Infections and infestations Enterococcus faecalis Bacteremia	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
Cardiac disorders Intermittent Atrial Fibrillation (AFib) with Labile Blood Pressure	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
Infections and infestations Methicillin-susceptible staphylococcus aureus (MSSA) Bacteremia	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
Infections and infestations Paritonsillar Cellulitis	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
Infections and infestations Respiratory Pseudomonas	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/8 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.	12.5% 1/8 • Number of events 1 • Day 60 Enrolled patients who received the initial dose of the IP were monitored and evaluated for adverse and severe adverse events.

Additional Information

Dr. Stanley C. Jordan, MD

Cedars Sinai Medical Center

Phone: 310-423-2641

Email: sjordan@cshs.org

Results disclosure agreements

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