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| Column | Value |
|---|---|
| Trial registration number | NCT04497987 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : April 22, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : April 22, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Clinicaltrials.gov@lilly.com |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-08-04 |
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Recruitment status
Last imported at : June 11, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Feb. 4, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - part 1 and part 2: resident or facility staff in a skilled nursing or assisted living facility with at least one confirmed case of sars-cov-2 detection less than or equal to (≤)7 days prior to randomization - are men or non-pregnant women who agree to contraceptive requirements - agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal swabs, and venous blood as specified in the schedule of activities - have venous access sufficient to allow intravenous infusions and blood sampling - the participant or legally authorized representative give signed informed consent - part 3 only: resident or staff in a skilled nursing or assisted living facility who satisfy at least one of the following at the time of screening - are greater than or equal to (≥) 65 years of age - have a body mass index (bmi) ≥ 35 - have chronic kidney disease - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment, or - are ≥ 55 years of age and have - cardiovascular disease, or - hypertension, or - chronic obstructive pulmonary disease or other chronic respiratory disease - positive sars-cov-2 test and infusion within 10 days of symptom onset, or positive sars-cov-2 test and infusion within 10 days of testing if asymptomatic |
|
Exclusion criteria
Last imported at : Feb. 4, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- parts 1 and 2: - recovered from confirmed covid-19 disease or asymptomatic infection - prior history of a positive sars-cov-2 serology test - history of convalescent covid-19 plasma treatment - participation in a previous sars-cov-2 vaccine trial or received an approved sars-cov-2 vaccine - previous receipt of sar-cov-2-specific monoclonal antibodies - have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study |
|
Number of arms
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
6 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Eli Lilly and Company |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
|
Total sample size
Last imported at : Feb. 6, 2022, 2 p.m. Source : ClinicalTrials.gov |
1180 |
|
primary outcome
Last imported at : Feb. 6, 2022, 2 p.m. Source : ClinicalTrials.gov |
Percentage of Participants With COVID-19 |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Feb. 6, 2022, 2 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 179, "treatment_name": "Bamlanivimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1426, "treatment_name": "Bamlanivimab+etesevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 179, "treatment_name": "Bamlanivimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1426, "treatment_name": "Bamlanivimab+etesevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |