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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: NCT04463004
Recruitment Status : Completed
First Posted : July 9, 2020
Results First Posted : August 11, 2021
Last Update Posted : August 11, 2021
Sponsor:
Collaborator:
Kiniksa Pharmaceuticals, Ltd.
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions COVID-19
Sars-CoV2
Pneumonia
Interventions Drug: Mavrilimumab
Drug: Placebos
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide Arm/Group Description

Treatment infusion

Mavrilimumab: Treatment infusion

Placebo infusion

Placebos: Placebo infusion
Period Title: Overall Study
Started 1 1
Completed 1 1
Not Completed 0 0
Arm/Group Title Intervention Control Total
Hide Arm/Group Description

Treatment infusion

Mavrilimumab: Treatment infusion

Placebo infusion

Placebos: Placebo infusion

 Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 2 participants
55  (0) 59  (0) 57  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
1
 100.0%
0
   0.0%
1
  50.0%
Male
0
   0.0%
1
 100.0%
1
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
1
 100.0%
1
 100.0%
2
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 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
0
   0.0%
1
 100.0%
1
  50.0%
White
1
 100.0%
0
   0.0%
1
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Proportion of Subjects Alive and Off of Oxygen at Day 14
Hide Description Number of subjects alive and off of oxygen
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Treatment infusion

Mavrilimumab: Treatment infusion

Placebo infusion

Placebos: Placebo infusion
Overall Number of Participants Analyzed 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
1
 100.0%
2.Secondary Outcome
Title Number of Subjects Alive and Without Respiratory Failure at 28 Days
Hide Description Number of subjects alive and without respiratory failure
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Treatment infusion

Mavrilimumab: Treatment infusion

Placebo infusion

Placebos: Placebo infusion
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
1 1
Time Frame 60 days
Adverse Event Reporting Description

Daily assessment and chart review with routine labs while in patient,

Virtual telehealth assessment on day 14, 21, 28 and 60.
 
Arm/Group Title Intervention Control
Hide Arm/Group Description

Treatment infusion

Mavrilimumab: Treatment infusion

Placebo infusion

Placebos: Placebo infusion
All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
[Not Specified]
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: Antonio Abbate, MD, PhD
Organization: Virginia Commonwealth University
Phone: 804-628-1215
EMail: antonio.abbate@vcuhealth.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04463004    
Other Study ID Numbers: HM20019145
First Submitted: July 7, 2020
First Posted: July 9, 2020
Results First Submitted: August 4, 2021
Results First Posted: August 11, 2021
Last Update Posted: August 11, 2021