Trial Outcomes & Findings for Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation (NCT NCT04463004)

NCT ID: NCT04463004

Last Updated: 2021-08-11

Results Overview

Number of subjects alive and off of oxygen

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

14 days

Results posted on

2021-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Treatment infusion Mavrilimumab: Treatment infusion	Control Placebo infusion Placebos: Placebo infusion
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=1 Participants Treatment infusion Mavrilimumab: Treatment infusion	Control n=1 Participants Placebo infusion Placebos: Placebo infusion	Total n=2 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 0 • n=99 Participants	59 years STANDARD_DEVIATION 0 • n=107 Participants	57 years STANDARD_DEVIATION 0 • n=206 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	1 participants n=99 Participants	1 participants n=107 Participants	2 participants n=206 Participants

PRIMARY outcome

Timeframe: 14 days

Number of subjects alive and off of oxygen

Outcome measures

Outcome measures
Measure	Intervention n=1 Participants Treatment infusion Mavrilimumab: Treatment infusion	Control n=1 Participants Placebo infusion Placebos: Placebo infusion
Proportion of Subjects Alive and Off of Oxygen at Day 14	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Number of subjects alive and without respiratory failure

Outcome measures

Outcome measures
Measure	Intervention n=1 Participants Treatment infusion Mavrilimumab: Treatment infusion	Control n=1 Participants Placebo infusion Placebos: Placebo infusion
Number of Subjects Alive and Without Respiratory Failure at 28 Days	1 participants	1 participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Antonio Abbate, MD, PhD

Virginia Commonwealth University

Phone: 804-628-1215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place