Trial · NCT04790786
UPMC OPTIMISE-C19 Trial, a COVID-19 Study
NCT04790786, Phase 4, Terminated, Erin McCreary; results first posted 2023-06-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. UPMC OPTIMISE-C19 Trial, a COVID-19 Study. Trials, record NCT04790786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04790786
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- UPMC OPTIMISE-C19 Trial, a COVID-19 Study
- NCT number
- NCT04790786
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 4,571 participants, actual
- Lead sponsor
- Erin McCreary
- Conditions
- Covid19
- Interventions
- Lilly Bamlanivimab, Regeneron Casirivimab + Imdevimab, Lilly Bamlanivimab + Etesevimab, Sotrovimab, Bebtelovimab
- First posted
- 2021-03-10
- Last updated
- 2023-06-15
- Results first posted
- 2023-06-15
- Limitations and caveats
Results are presented before any prespecified statistical trigger was reached. Lack of patient-level variant data limited ability to assess comparative effectiveness relative to variant strains. The EHR eligibility screen identified most, but not all, EUA risk factors and could not identify if a patient was asymptomatic or severely ill. Finally, vaccination status was unable to be ascertained for this cohort which may impact effectiveness of monoclonal antibody therapy.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hospital-free Days | 28 days after initial participation | 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. |
| Secondary | All-cause Mortality at 28 Days | 28 days after initial participation | All-cause mortality at 28 days. |
| Secondary | SARS-CoV-2 Nasopharyngeal Viral Loads | 28 days after initial participation | Where feasible SARS-CoV-2 nasopharyngeal viral loads among participants from baseline and longitudinally through day 28 |
| Secondary | SARS-CoV-2 Plasma Viral Loads | 28 days after initial participation | Where feasible SARS-CoV-2 plasma viral loads among participants from baseline and longitudinally through day 28 |
| Secondary | SARS-CoV-2 Antibody Titers | 28 days after initial participation | Where feasible SARS-CoV-2 antibody titers at baseline and longitudinally through day 28 |
| Secondary | SARS-CoV-2 Antibody Neutralization | 28 days after initial participation | Where feasible SARS-CoV-2 antibody neutralization at baseline and longitudinally through day 28 |
| Secondary | SARS-CoV-2 Immune Responses | 28 days after initial participation | Where feasible SARS-CoV-2 immune responses at baseline and longitudinally through day 28 |
| Secondary | Detection of SARS-CoV-2 Variants Through Next-generation Sequencing | 28 days after initial participation | Where feasible detection of SARS-CoV-2 variants through next-generation sequencing at baseline and longitudinally through day 28 |
| Secondary | Duration of SAR-CoV-2 Infectivity | 28 days after initial participation | Where feasible determining the duration of SAR-CoV-2 infectivity among patients with persistent nasopharyngeal swab viral shedding |
| Secondary | Non-culture Surrogates for SARS-CoV-2 Infectivity | 28 days after initial participation | Where feasible determining non-culture surrogates for SARS-CoV-2 infectivity among patients with persistent nasopharyngeal swab viral shedding |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hospital-free Days | 28 days after initial participation | Every patient who received mAb treatment | days | MEDIAN |
| SECONDARY | All-cause Mortality at 28 Days | 28 days after initial participation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | SARS-CoV-2 Nasopharyngeal Viral Loads | 28 days after initial participation | Participants were not consented for samples due to limited trial resources, data not collected | ||
| SECONDARY | SARS-CoV-2 Plasma Viral Loads | 28 days after initial participation | Participants were not consented for samples due to limited trial resources, data not collected | ||
| SECONDARY | SARS-CoV-2 Antibody Titers | 28 days after initial participation | Participants were not consented for samples due to limited trial resources, data not collected | ||
| SECONDARY | SARS-CoV-2 Antibody Neutralization | 28 days after initial participation | Participants were not consented for samples due to limited trial resources, data not collected | ||
| SECONDARY | SARS-CoV-2 Immune Responses | 28 days after initial participation | Participants were not consented for samples due to limited trial resources, data not collected | ||
| SECONDARY | Detection of SARS-CoV-2 Variants Through Next-generation Sequencing | 28 days after initial participation | Participants were not consented for samples due to limited trial resources, data not collected | ||
| SECONDARY | Duration of SAR-CoV-2 Infectivity | 28 days after initial participation | Participants were not consented for samples due to limited trial resources, data not collected | ||
| SECONDARY | Non-culture Surrogates for SARS-CoV-2 Infectivity | 28 days after initial participation | Participants were not consented for samples due to limited trial resources, data not collected |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hospital-free Days | Lilly Bamlanivimab | 28 | Inter-Quartile Range 28 to 28 | days | |
| Hospital-free Days | Regeneron Casirivimab + Imdevimab | 28 | Inter-Quartile Range 28 to 28 | days | |
| Hospital-free Days | Lilly Bamlanivimab + Etesevimab | 28 | Inter-Quartile Range 28 to 28 | days | |
| Hospital-free Days | Sotrovimab | 28 | Inter-Quartile Range 28 to 28 | days | |
| All-cause Mortality at 28 Days | Lilly Bamlanivimab | 1 | Participants | ||
| All-cause Mortality at 28 Days | Regeneron Casirivimab + Imdevimab | 12 | Participants | ||
| All-cause Mortality at 28 Days | Lilly Bamlanivimab + Etesevimab | 7 | Participants | ||
| All-cause Mortality at 28 Days | Sotrovimab | 7 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lilly Bamlanivimab | 128 | |
| Overall Study | STARTED | Regeneron Casirivimab + Imdevimab | 2,454 | |
| Overall Study | STARTED | Lilly Bamlanivimab + Etesevimab | 885 | |
| Overall Study | STARTED | Sotrovimab | 1,104 | |
| Overall Study | COMPLETED | Lilly Bamlanivimab | 128 | |
| Overall Study | COMPLETED | Regeneron Casirivimab + Imdevimab | 2,454 | |
| Overall Study | COMPLETED | Lilly Bamlanivimab + Etesevimab | 885 | |
| Overall Study | COMPLETED | Sotrovimab | 1,104 | |
| Overall Study | NOT COMPLETED | Lilly Bamlanivimab | 0 | |
| Overall Study | NOT COMPLETED | Regeneron Casirivimab + Imdevimab | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | infusion reaction | Product Issues | Lilly Bamlanivimab | 0 | 128 | 0 |
| other | infusion reaction | Product Issues | Regeneron Casirivimab + Imdevimab | 17 | 2,454 | 17 |
| other | infusion reaction | Product Issues | Lilly Bamlanivimab + Etesevimab | 12 | 885 | 12 |
| other | infusion reaction | Product Issues | Sotrovimab | 6 | 1,104 | 6 |
| serious | chest pain | Cardiac disorders | Lilly Bamlanivimab | 0 | 128 | 0 |
| serious | chest pain | Cardiac disorders | Regeneron Casirivimab + Imdevimab | 2 | 2,454 | 2 |
| serious | chest pain | Cardiac disorders | Lilly Bamlanivimab + Etesevimab | 0 | 885 | 0 |
| serious | chest pain | Cardiac disorders | Sotrovimab | 2 | 1,104 | 2 |
| serious | other infusion reaction | Product Issues | Lilly Bamlanivimab | 0 | 128 | 0 |
| serious | other infusion reaction | Product Issues | Regeneron Casirivimab + Imdevimab | 5 | 2,454 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lilly Bamlanivimab | 1 | 128 |
| Total, all-cause mortality | Regeneron Casirivimab + Imdevimab | 12 | 2,454 |
| Total, all-cause mortality | Lilly Bamlanivimab + Etesevimab | 7 | 885 |
| Total, all-cause mortality | Sotrovimab | 7 | 1,104 |
| Total, other adverse events | Lilly Bamlanivimab | 0 | 128 |
| Total, other adverse events | Regeneron Casirivimab + Imdevimab | 17 | 2,454 |
| Total, other adverse events | Lilly Bamlanivimab + Etesevimab | 12 | 885 |
| Total, other adverse events | Sotrovimab | 6 | 1,104 |
| Total, serious adverse events | Lilly Bamlanivimab | 0 | 128 |
| Total, serious adverse events | Regeneron Casirivimab + Imdevimab | 7 | 2,454 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04790786
GET https://conductscience.org/api/trials/v1/NCT04790786/registered