Trial Outcomes & Findings for Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation (NCT NCT04492514)

NCT ID: NCT04492514

Last Updated: 2024-12-09

Results Overview

Number of subjects alive and off of oxygen

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2024-12-09

Participant Flow

Participant milestones

Measure	Mavrilimumab Mavrilimumab Treatment infusion Mavrilimumab: Treatment infusion	Placebo Placebo infusion Placebo: Placebo infusion
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
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

Measure	Mavrilimumab n=1 Participants Mavrilimumab Treatment infusion Mavrilimumab: Treatment infusion	Placebo Placebo infusion Placebo: Placebo infusion	Total n=1 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 0 • n=5 Participants	—	66 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Only 1 participant was enrolled at our site and this individual received Mavrilimumab. We did not enroll any patients into the placebo group.

Number of subjects alive and off of oxygen

Outcome measures

Measure	Mavrilimumab n=1 Participants Mavrilimumab Treatment infusion Mavrilimumab: Treatment infusion	Placebo Placebo infusion Placebo: Placebo infusion
Proportion of Subjects Alive and Off Oxygen at 14 Days	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Only 1 participant was enrolled at our site and this individual received Mavrilimumab. We did not enroll any patients into the placebo group.

Number of subjects alive and without respiratory failure

Outcome measures

Measure	Mavrilimumab n=1 Participants Mavrilimumab Treatment infusion Mavrilimumab: Treatment infusion	Placebo Placebo infusion Placebo: Placebo infusion
Proportion of Subjects Alive and Without Respiratory Failure at 28 Days	1 Participants	0 Participants

Adverse Events

Mavrilimumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mavrilimumab n=1 participants at risk Mavrilimumab Treatment infusion Mavrilimumab: Treatment infusion	Placebo Placebo infusion Placebo: Placebo infusion
Respiratory, thoracic and mediastinal disorders Chest Cold	100.0% 1/1 • Number of events 1 • 60 days Daily assessment and chart review with routine labs while inpatient. Virtual telehealth assessment on day 14, 21, 28, and 60.	— 0/0 • 60 days Daily assessment and chart review with routine labs while inpatient. Virtual telehealth assessment on day 14, 21, 28, and 60.

Additional Information

Clinical Research Director

University of Cincinnati

Phone: 513-584-0156

Email: mcmahasn@ucmail.uc.edu

Results disclosure agreements

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