Trial Outcomes & Findings for A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19) (NCT NCT04701658)

NCT ID: NCT04701658

Last Updated: 2021-11-16

Results Overview

Percentage of Participants who Experience COVID-19 Related Hospitalization or Death From Any Cause. Hospitalization is defined as ≥24 hours of acute care.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 109 participants
• Primary outcome timeframe: Baseline through Days 29, 60, and 90
• Results posted on: 2021-11-16

Participant Flow

The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized.

Participant milestones

Measure	Bamlanivimab 700 Milligram (mg) Participants received 700 mg single intravenous (IV) infusion of Bamlanivimab.
Overall Study STARTED	109
Overall Study Received Single Dose of Bamlanivimab	109
Overall Study COMPLETED	103
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Bamlanivimab 700 Milligram (mg) Participants received 700 mg single intravenous (IV) infusion of Bamlanivimab.
Overall Study Lost to Follow-up	6

Baseline Characteristics

A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)

Baseline characteristics by cohort

Measure	Bamlanivimab 700 mg n=109 Participants Participants received 700 mg single IV infusion of Bamlanivimab.
Age, Continuous	55.40 years STANDARD_DEVIATION 15.34 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants
Region of Enrollment United States	109 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through Days 29, 60, and 90

Population: All participants who received single dose of Bamlanivimab.

Percentage of Participants who Experience COVID-19 Related Hospitalization or Death From Any Cause. Hospitalization is defined as ≥24 hours of acute care.

Outcome measures

Measure	Bamlanivimab 700 mg n=109 Participants Participants received 700 mg single IV infusion of Bamlanivimab.
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause Baseline through Day 29	0.9 Percentage of participants Interval 0.0 to 2.7
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause Baseline through Day 60	0.9 Percentage of participants Interval 0.0 to 2.7
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause Baseline through Day 90	0.9 Percentage of participants Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: Baseline through Days 29, 60, and 90

Population: All participants who received single dose of Bamlanivimab.

Hospitalization is defined as ≥24 hours of acute care.

Outcome measures

Measure	Bamlanivimab 700 mg n=109 Participants Participants received 700 mg single IV infusion of Bamlanivimab.
Percentage of Participants With a COVID-19-related Hospitalization Baseline through Day 29	0.9 Percentage of participants Interval 0.0 to 2.7
Percentage of Participants With a COVID-19-related Hospitalization Baseline through Day 60	0.9 Percentage of participants Interval 0.0 to 2.7
Percentage of Participants With a COVID-19-related Hospitalization Baseline through Day 90	0.9 Percentage of participants Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: Baseline through Days 29, 60, and 90

Population: All participants who received single dose of Bamlanivimab.

Percentage of Participants with a COVID-related ED Visit.

Outcome measures

Measure	Bamlanivimab 700 mg n=109 Participants Participants received 700 mg single IV infusion of Bamlanivimab.
Percentage of Participants With a COVID-related Emergency Department (ED) Visit Baseline through Day 29	5.5 Percentage of participants Interval 1.2 to 9.8
Percentage of Participants With a COVID-related Emergency Department (ED) Visit Baseline through Day 60	5.5 Percentage of participants Interval 1.2 to 9.8
Percentage of Participants With a COVID-related Emergency Department (ED) Visit Baseline through Day 90	5.5 Percentage of participants Interval 1.2 to 9.8

Adverse Events

Bamlanivimab 700 mg

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bamlanivimab 700 mg n=109 participants at risk Participants received 700 mg single IV infusion of Bamlanivimab.
Hepatobiliary disorders Cholelithiasis	0.92% 1/109 • Number of events 1 • Baseline through Follow-up (Up to 90 days) All participants who received single dose of Bamlanivimab.
Renal and urinary disorders End stage renal disease	0.92% 1/109 • Number of events 1 • Baseline through Follow-up (Up to 90 days) All participants who received single dose of Bamlanivimab.

Other adverse events

Measure	Bamlanivimab 700 mg n=109 participants at risk Participants received 700 mg single IV infusion of Bamlanivimab.
Cardiac disorders Tachycardia	0.92% 1/109 • Number of events 1 • Baseline through Follow-up (Up to 90 days) All participants who received single dose of Bamlanivimab.
Eye disorders Vision blurred	0.92% 1/109 • Number of events 1 • Baseline through Follow-up (Up to 90 days) All participants who received single dose of Bamlanivimab.
General disorders Infusion site extravasation	4.6% 5/109 • Number of events 5 • Baseline through Follow-up (Up to 90 days) All participants who received single dose of Bamlanivimab.
Nervous system disorders Headache	0.92% 1/109 • Number of events 1 • Baseline through Follow-up (Up to 90 days) All participants who received single dose of Bamlanivimab.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.92% 1/109 • Number of events 1 • Baseline through Follow-up (Up to 90 days) All participants who received single dose of Bamlanivimab.
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	0.92% 1/109 • Number of events 1 • Baseline through Follow-up (Up to 90 days) All participants who received single dose of Bamlanivimab.
Skin and subcutaneous tissue disorders Rash	0.92% 1/109 • Number of events 1 • Baseline through Follow-up (Up to 90 days) All participants who received single dose of Bamlanivimab.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

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

Restriction type: GT60