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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04342897 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Clinicaltrials.gov@lilly.com |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-13 |
|
Recruitment status
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Terminated |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
|
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 |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - are hospitalized with pneumonia, and presumed or confirmed covid-19 - are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed) |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- female participants must not be pregnant and/or lactating - have acute respiratory distress syndrome (ards) or will require immediate intermittent mandatory ventilation (imv), or are ineligible for imv - have any concurrent serious medical condition (for example dialysis) or concomitant medication that would preclude participation in the study - are moribund irrespective of the provision of treatments - have a known history or show evidence of human immunodeficiency virus (hiv) and/or hepatitis - have recently undergone major surgery or central venous access device placement - have a significant bleeding disorder or active vasculitis - have experienced a thromboembolic event - have symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia - have a serious, nonhealing wound, peptic ulcer, or bone fracture - have liver cirrhosis - have a known sensitivity to monoclonal antibodies (mabs) or other therapeutic proteins - have a history of hypertensive crisis or hypertensive encephalopathy or current, poorly controlled hypertension |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
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 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
3: Moderate disease at enrollment |
|
Total sample size
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
95 |
|
primary outcome
Last imported at : Aug. 13, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
Ventilator Free Days |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 758, "treatment_name": "Ly3127804", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |