Trial Outcomes & Findings for UPMC OPTIMISE-C19 Trial, a COVID-19 Study (NCT NCT04790786)

NCT ID: NCT04790786

Last Updated: 2023-06-15

Results Overview

Days alive and free from hospitalization. Patients that are both living and not in the hospital will meet criteria to be counted in this outcome. Deaths were rare and therefore the upper and lower end of the IQR are both 28, in addition to the median. This outcome measure does reflect median hospital free days and interquartile ranges for all groups.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 4571 participants
• Primary outcome timeframe: 28 days after initial participation
• Results posted on: 2023-06-15

Participant Flow

Participant milestones

Measure	Lilly Bamlanivimab The Lilly monoclonal antibody bamlanivimab will be administered according to FDA EUA guidelines. Dosing is 700 mg intravenously times one within 10 days of COVID-19 symptom onset. Lilly Bamlanivimab: Administration of Lilly Bamlanivimab to COVID positive patients	Regeneron Casirivimab + Imdevimab The Regeneron monoclonal antibody cocktail Casirivimab + Imdevimab will be administered according to FDA EUA guidelines. Dosing is 1200 mg of each drug (2400 mg total) administered intravenously times one within 10 days of COVID-19 symptom onset. Regeneron Casirivimab + Imdevimab: Administration of Regeneron Casirivimab + Imdevimab to COVID positive patients	Lilly Bamlanivimab + Etesevimab The Lilly monoclonal antibody cocktail of bamlanivimab + etesevimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 10 days of COVID-19 symptom onset. Lilly Bamlanivimab + Etesevimab: Administration of Lilly Bamlanivimab + Etesevimab to COVID positive patients	Sotrovimab The monoclonal antibody of sotrovimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 7 days of COVID-19 symptom onset. Sotrovimab: Administration of Sotrovimab to COVID positive patients
Overall Study STARTED	128	2454	885	1104
Overall Study COMPLETED	128	2454	885	1104
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

UPMC OPTIMISE-C19 Trial, a COVID-19 Study

Baseline characteristics by cohort

Measure	Lilly Bamlanivimab n=128 Participants The Lilly monoclonal antibody bamlanivimab will be administered according to FDA EUA guidelines. Dosing is 700 mg intravenously times one within 10 days of COVID-19 symptom onset. Lilly Bamlanivimab: Administration of Lilly Bamlanivimab to COVID positive patients	Regeneron Casirivimab + Imdevimab n=2454 Participants The Regeneron monoclonal antibody cocktail Casirivimab + Imdevimab will be administered according to FDA EUA guidelines. Dosing is 1200 mg of each drug (2400 mg total) administered intravenously times one within 10 days of COVID-19 symptom onset. Regeneron Casirivimab + Imdevimab: Administration of Regeneron Casirivimab + Imdevimab to COVID positive patients	Lilly Bamlanivimab + Etesevimab n=885 Participants The Lilly monoclonal antibody cocktail of bamlanivimab + etesevimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 10 days of COVID-19 symptom onset. Lilly Bamlanivimab + Etesevimab: Administration of Lilly Bamlanivimab + Etesevimab to COVID positive patients	Sotrovimab n=1104 Participants The monoclonal antibody of sotrovimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 7 days of COVID-19 symptom onset. Sotrovimab: Administration of Sotrovimab to COVID positive patients	Total n=4571 Participants Total of all reporting groups
Age, Continuous	57 years STANDARD_DEVIATION 17 • n=5 Participants	54 years STANDARD_DEVIATION 18 • n=7 Participants	56 years STANDARD_DEVIATION 16 • n=5 Participants	53 years STANDARD_DEVIATION 18 • n=4 Participants	54 years STANDARD_DEVIATION 18 • n=21 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	1320 Participants n=7 Participants	470 Participants n=5 Participants	599 Participants n=4 Participants	2458 Participants n=21 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	1134 Participants n=7 Participants	415 Participants n=5 Participants	505 Participants n=4 Participants	2113 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	252 Participants n=7 Participants	148 Participants n=5 Participants	161 Participants n=4 Participants	576 Participants n=21 Participants
Race (NIH/OMB) White	104 Participants n=5 Participants	2089 Participants n=7 Participants	693 Participants n=5 Participants	892 Participants n=4 Participants	3778 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	113 Participants n=7 Participants	44 Participants n=5 Participants	51 Participants n=4 Participants	217 Participants n=21 Participants

PRIMARY outcome

Timeframe: 28 days after initial participation

Population: Every patient who received mAb treatment

Days alive and free from hospitalization. Patients that are both living and not in the hospital will meet criteria to be counted in this outcome. Deaths were rare and therefore the upper and lower end of the IQR are both 28, in addition to the median. This outcome measure does reflect median hospital free days and interquartile ranges for all groups.

Outcome measures

Measure	Lilly Bamlanivimab n=128 Participants The Lilly monoclonal antibody bamlanivimab will be administered according to FDA EUA guidelines. Dosing is 700 mg intravenously times one within 10 days of COVID-19 symptom onset. Lilly Bamlanivimab: Administration of Lilly Bamlanivimab to COVID positive patients	Regeneron Casirivimab + Imdevimab n=2454 Participants The Regeneron monoclonal antibody cocktail Casirivimab + Imdevimab will be administered according to FDA EUA guidelines. Dosing is 1200 mg of each drug (2400 mg total) administered intravenously times one within 10 days of COVID-19 symptom onset. Regeneron Casirivimab + Imdevimab: Administration of Regeneron Casirivimab + Imdevimab to COVID positive patients	Lilly Bamlanivimab + Etesevimab n=885 Participants The Lilly monoclonal antibody cocktail of bamlanivimab + etesevimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 10 days of COVID-19 symptom onset. Lilly Bamlanivimab + Etesevimab: Administration of Lilly Bamlanivimab + Etesevimab to COVID positive patients	Sotrovimab n=1104 Participants The monoclonal antibody of sotrovimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 7 days of COVID-19 symptom onset. Sotrovimab: Administration of Sotrovimab to COVID positive patients	Bebtelovimab The monoclonal antibody of bebtelovimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 7 days of COVID-19 symptom onset. Bebtelovimab: Administration of Bebtelovimab to COVID positive patients
Hospital-free Days	28 days Interval 28.0 to 28.0	28 days Interval 28.0 to 28.0	28 days Interval 28.0 to 28.0	28 days Interval 28.0 to 28.0	—

SECONDARY outcome

Timeframe: 28 days after initial participation

All-cause mortality at 28 days.

Outcome measures

Measure	Lilly Bamlanivimab n=128 Participants The Lilly monoclonal antibody bamlanivimab will be administered according to FDA EUA guidelines. Dosing is 700 mg intravenously times one within 10 days of COVID-19 symptom onset. Lilly Bamlanivimab: Administration of Lilly Bamlanivimab to COVID positive patients	Regeneron Casirivimab + Imdevimab n=2454 Participants The Regeneron monoclonal antibody cocktail Casirivimab + Imdevimab will be administered according to FDA EUA guidelines. Dosing is 1200 mg of each drug (2400 mg total) administered intravenously times one within 10 days of COVID-19 symptom onset. Regeneron Casirivimab + Imdevimab: Administration of Regeneron Casirivimab + Imdevimab to COVID positive patients	Lilly Bamlanivimab + Etesevimab n=885 Participants The Lilly monoclonal antibody cocktail of bamlanivimab + etesevimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 10 days of COVID-19 symptom onset. Lilly Bamlanivimab + Etesevimab: Administration of Lilly Bamlanivimab + Etesevimab to COVID positive patients	Sotrovimab n=1104 Participants The monoclonal antibody of sotrovimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 7 days of COVID-19 symptom onset. Sotrovimab: Administration of Sotrovimab to COVID positive patients	Bebtelovimab The monoclonal antibody of bebtelovimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 7 days of COVID-19 symptom onset. Bebtelovimab: Administration of Bebtelovimab to COVID positive patients
All-cause Mortality at 28 Days	1 Participants	12 Participants	7 Participants	7 Participants	—

SECONDARY outcome

Timeframe: 28 days after initial participation

Population: Participants were not consented for samples due to limited trial resources, data not collected

Where feasible SARS-CoV-2 nasopharyngeal viral loads among participants from baseline and longitudinally through day 28

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days after initial participation

Population: Participants were not consented for samples due to limited trial resources, data not collected

Where feasible SARS-CoV-2 plasma viral loads among participants from baseline and longitudinally through day 28

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days after initial participation

Population: Participants were not consented for samples due to limited trial resources, data not collected

Where feasible SARS-CoV-2 antibody titers at baseline and longitudinally through day 28

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days after initial participation

Population: Participants were not consented for samples due to limited trial resources, data not collected

Where feasible SARS-CoV-2 antibody neutralization at baseline and longitudinally through day 28

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days after initial participation

Population: Participants were not consented for samples due to limited trial resources, data not collected

Where feasible SARS-CoV-2 immune responses at baseline and longitudinally through day 28

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days after initial participation

Population: Participants were not consented for samples due to limited trial resources, data not collected

Where feasible detection of SARS-CoV-2 variants through next-generation sequencing at baseline and longitudinally through day 28

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days after initial participation

Population: Participants were not consented for samples due to limited trial resources, data not collected

Where feasible determining the duration of SAR-CoV-2 infectivity among patients with persistent nasopharyngeal swab viral shedding

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days after initial participation

Population: Participants were not consented for samples due to limited trial resources, data not collected

Where feasible determining non-culture surrogates for SARS-CoV-2 infectivity among patients with persistent nasopharyngeal swab viral shedding

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days after initial participation

Population: Participants were not consented for samples due to limited trial resources, data not collected

Where feasible determining non-culture surrogates for SARS-CoV-2 infectivity among patients with persistent nasopharyngeal swab viral shedding

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days after initial participation

Population: Analysis not feasible due to limitations of pandemic, Participants were not consented for samples due to limited trial resources, data not collected

Where feasible determining the duration of SAR-CoV-2 infectivity among patients with persistent nasopharyngeal swab viral shedding

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of study

Population: Not feasible due to nature of data and treatment sites during pandemic, data not collected

Outcome measures

Outcome data not reported

Adverse Events

Lilly Bamlanivimab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Regeneron Casirivimab + Imdevimab

Serious events: 7 serious events

Other events: 17 other events

Deaths: 12 deaths

Lilly Bamlanivimab + Etesevimab

Serious events: 0 serious events

Other events: 12 other events

Deaths: 7 deaths

Sotrovimab

Serious events: 4 serious events

Other events: 6 other events

Deaths: 7 deaths

Serious adverse events

Measure	Lilly Bamlanivimab n=128 participants at risk The Lilly monoclonal antibody bamlanivimab will be administered according to FDA EUA guidelines. Dosing is 700 mg intravenously times one within 10 days of COVID-19 symptom onset. Lilly Bamlanivimab: Administration of Lilly Bamlanivimab to COVID positive patients	Regeneron Casirivimab + Imdevimab n=2454 participants at risk The Regeneron monoclonal antibody cocktail Casirivimab + Imdevimab will be administered according to FDA EUA guidelines. Dosing is 1200 mg of each drug (2400 mg total) administered intravenously times one within 10 days of COVID-19 symptom onset. Regeneron Casirivimab + Imdevimab: Administration of Regeneron Casirivimab + Imdevimab to COVID positive patients	Lilly Bamlanivimab + Etesevimab n=885 participants at risk The Lilly monoclonal antibody cocktail of bamlanivimab + etesevimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 10 days of COVID-19 symptom onset. Lilly Bamlanivimab + Etesevimab: Administration of Lilly Bamlanivimab + Etesevimab to COVID positive patients	Sotrovimab n=1104 participants at risk The monoclonal antibody of sotrovimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 7 days of COVID-19 symptom onset. Sotrovimab: Administration of Sotrovimab to COVID positive patients
Cardiac disorders chest pain	0.00% 0/128 • 6 months Adverse events were reported by treating clinicians at each treatment center in a secure, nonpunative, system safety database and adjudicated by study researchers	0.08% 2/2454 • Number of events 2 • 6 months Adverse events were reported by treating clinicians at each treatment center in a secure, nonpunative, system safety database and adjudicated by study researchers	0.00% 0/885 • 6 months Adverse events were reported by treating clinicians at each treatment center in a secure, nonpunative, system safety database and adjudicated by study researchers	0.18% 2/1104 • Number of events 2 • 6 months Adverse events were reported by treating clinicians at each treatment center in a secure, nonpunative, system safety database and adjudicated by study researchers
Product Issues other infusion reaction	0.00% 0/128 • 6 months Adverse events were reported by treating clinicians at each treatment center in a secure, nonpunative, system safety database and adjudicated by study researchers	0.20% 5/2454 • Number of events 5 • 6 months Adverse events were reported by treating clinicians at each treatment center in a secure, nonpunative, system safety database and adjudicated by study researchers	0.00% 0/885 • 6 months Adverse events were reported by treating clinicians at each treatment center in a secure, nonpunative, system safety database and adjudicated by study researchers	0.18% 2/1104 • Number of events 2 • 6 months Adverse events were reported by treating clinicians at each treatment center in a secure, nonpunative, system safety database and adjudicated by study researchers

Other adverse events

Measure	Lilly Bamlanivimab n=128 participants at risk The Lilly monoclonal antibody bamlanivimab will be administered according to FDA EUA guidelines. Dosing is 700 mg intravenously times one within 10 days of COVID-19 symptom onset. Lilly Bamlanivimab: Administration of Lilly Bamlanivimab to COVID positive patients	Regeneron Casirivimab + Imdevimab n=2454 participants at risk The Regeneron monoclonal antibody cocktail Casirivimab + Imdevimab will be administered according to FDA EUA guidelines. Dosing is 1200 mg of each drug (2400 mg total) administered intravenously times one within 10 days of COVID-19 symptom onset. Regeneron Casirivimab + Imdevimab: Administration of Regeneron Casirivimab + Imdevimab to COVID positive patients	Lilly Bamlanivimab + Etesevimab n=885 participants at risk The Lilly monoclonal antibody cocktail of bamlanivimab + etesevimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 10 days of COVID-19 symptom onset. Lilly Bamlanivimab + Etesevimab: Administration of Lilly Bamlanivimab + Etesevimab to COVID positive patients	Sotrovimab n=1104 participants at risk The monoclonal antibody of sotrovimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 7 days of COVID-19 symptom onset. Sotrovimab: Administration of Sotrovimab to COVID positive patients
Product Issues infusion reaction	0.00% 0/128 • 6 months Adverse events were reported by treating clinicians at each treatment center in a secure, nonpunative, system safety database and adjudicated by study researchers	0.69% 17/2454 • Number of events 17 • 6 months Adverse events were reported by treating clinicians at each treatment center in a secure, nonpunative, system safety database and adjudicated by study researchers	1.4% 12/885 • Number of events 12 • 6 months Adverse events were reported by treating clinicians at each treatment center in a secure, nonpunative, system safety database and adjudicated by study researchers	0.54% 6/1104 • Number of events 6 • 6 months Adverse events were reported by treating clinicians at each treatment center in a secure, nonpunative, system safety database and adjudicated by study researchers

Additional Information

Erin McCreary

UPMC

Phone: 4845159589

Email: mccrearye3@upmc.edu

Results disclosure agreements

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