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Trial record 3 of 5 for:    mavrilimumab in severe COVID-19

Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399980
Recruitment Status : Completed
First Posted : May 22, 2020
Results First Posted : May 13, 2021
Last Update Posted : May 13, 2021
Sponsor:
Collaborator:
Kiniksa Pharmaceuticals, Ltd.
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions COVID 19
SARS-CoV 2
Pneumonia
Interventions Drug: Mavrilimumab
Drug: Placebos
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide Arm/Group Description One-time Mavrilimumab infusion at 6mg/kg via IV One-time placebo infusion via IV
Period Title: Overall Study
Started 21 19
Completed 21 19
Not Completed 0 0
Arm/Group Title Intervention Control Total
Hide Arm/Group Description One-time Mavrilimumab infusion at 6mg/kg via IV One-time placebo infusion via IV Total of all reporting groups
Overall Number of Baseline Participants 21 19 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 19 participants 40 participants
56.7  (13.49) 54.8  (18.44) 55.75  (15.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
Female
7
  33.3%
7
  36.8%
14
  35.0%
Male
14
  66.7%
12
  63.2%
26
  65.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  38.1%
8
  42.1%
16
  40.0%
White
11
  52.4%
8
  42.1%
19
  47.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   9.5%
3
  15.8%
5
  12.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 21 participants 19 participants 40 participants
21
 100.0%
19
 100.0%
40
 100.0%
History of Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
8
  38.1%
9
  47.4%
17
  42.5%
History of Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
10
  47.6%
12
  63.2%
22
  55.0%
History of Hyperlipidemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
7
  33.3%
11
  57.9%
18
  45.0%
1.Primary Outcome
Title Subjects Alive and Off of Oxygen at Day 14
Hide Description Number and percentage of subjects alive and off of oxygen at day 14
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:
One-time Mavrilimumab infusion at 6mg/kg via IV
One-time placebo infusion via IV
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
12
  57.1%
9
  47.4%
2.Secondary Outcome
Title Number of Subjects Alive and Without Respiratory Failure at Day 28
Hide Description Number and percentage of subjects that are alive and without respiratory failure at Day 28
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:
One-time Mavrilimumab infusion at 6mg/kg via IV
One-time placebo infusion via IV
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
20
  95.2%
15
  78.9%
3.Secondary Outcome
Title Mortality at Day 28
Hide Description Number and percentage of patients that expired by Day 28
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:
One-time Mavrilimumab infusion at 6mg/kg via IV
One-time placebo infusion via IV
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.8%
3
  15.8%
Time Frame 60 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Control
Hide Arm/Group Description One-time Mavrilimumab infusion at 6kg/mg via IV One-time placebo infusion via IV
All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   1/21 (4.76%)      4/19 (21.05%)    
Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/21 (23.81%)      4/19 (21.05%)    
General disorders     
Nausea   1/21 (4.76%)  1 0/19 (0.00%)  0
Shock   1/21 (4.76%)  1 0/19 (0.00%)  0
Investigations     
Elevated WBC   0/21 (0.00%)  0 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress Syndrome   3/21 (14.29%)  3 2/19 (10.53%)  2
Pneumonia   2/21 (9.52%)  2 1/19 (5.26%)  1
Chronic Respiratory Failure   0/21 (0.00%)  0 1/19 (5.26%)  1
Hypoxia - Worsening   2/21 (9.52%)  2 3/19 (15.79%)  3
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/21 (57.14%)      8/19 (42.11%)    
Blood and lymphatic system disorders     
anemia   2/21 (9.52%)  2 2/19 (10.53%)  2
Pulmonary Embolism   2/21 (9.52%)  2 1/19 (5.26%)  1
Clot   1/21 (4.76%)  1 1/19 (5.26%)  1
Cardiac disorders     
Arrhythmia   0/21 (0.00%)  0 2/19 (10.53%)  2
Hypotension   0/21 (0.00%)  0 1/19 (5.26%)  1
General disorders     
Headache   0/21 (0.00%)  0 1/19 (5.26%)  1
Shock   2/21 (9.52%)  2 1/19 (5.26%)  1
Hepatobiliary disorders     
Liver Dysfunction   3/21 (14.29%)  3 0/19 (0.00%)  0
Worsening D Dimer   0/21 (0.00%)  0 1/19 (5.26%)  1
Infections and infestations     
Fever   0/21 (0.00%)  0 1/19 (5.26%)  1
Investigations     
Hypophosphatemia   1/21 (4.76%)  1 0/19 (0.00%)  0
Elevated Ferritin   0/21 (0.00%)  0 1/19 (5.26%)  1
Elevated CRP   0/21 (0.00%)  0 1/19 (5.26%)  1
Nervous system disorders     
Delirium   1/21 (4.76%)  1 1/19 (5.26%)  1
Renal and urinary disorders     
Acute Kidney Injury   4/21 (19.05%)  4 3/19 (15.79%)  3
Respiratory, thoracic and mediastinal disorders     
Pneumonia   3/21 (14.29%)  3 2/19 (10.53%)  2
Acute Respiratory Syndrome   3/21 (14.29%)  3 4/19 (21.05%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul C. Cremer, MD
Organization: Cleveland Clinic
Phone: 216-444-6765
EMail: cremerp@ccf.org
Layout table for additonal information
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04399980    
Other Study ID Numbers: IND 149324
IRB 20-523 ( Other Identifier: Cleveland Clinic IRB )
First Submitted: May 21, 2020
First Posted: May 22, 2020
Results First Submitted: May 6, 2021
Results First Posted: May 13, 2021
Last Update Posted: May 13, 2021