Publication Chen P, N Engl J Med, 2020 (published paper)
Dates: 2020-06-17 to 2020-08-21
Funding: Private (Eli Lilly)
Conflict of interest: Yes
Multicenter / USA |
Follow-up duration (days): 29
|Inclusion criteria||≥18 years of age at the time of randomization; Not hospitalized; One or more mild or moderate COVID-19 symptoms (Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion); Sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion; Men or non-pregnant women who agree to contraceptive requirements; Understand and agree to comply with planned study procedures; Agree to the collection of nasopharyngeal swabs and venous blood; Participant or legally authorized representative give signed informed consent|
|Exclusion criteria||Oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) less than (<)300, respiratory rate greater than or equal to (≥)30 per minute, heart rate ≥125 per minute; |
Require mechanical ventilation or anticipated impending need for mechanical ventilation; Have known allergies to any of the components used in the formulation of the interventions; Have hemodynamic instability requiring use of pressors within 24 hours of randomization; Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention; Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days; Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study; Have a history of a positive SARS-CoV-2 serology test; Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study; Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing; Have received treatment with a SARS-CoV-2 specific monoclonal antibody; Have a history of convalescent COVID-19 plasma treatment; Have participated in a previous SARS-CoV-2 vaccine study; Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed; Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study; Pregnant or breastfeeding
700/2800/7000mg arms merged, IV, once off for 1 hour.
Duration : 1 hour
467 participants (n1=317 / n2= 150)
|Characteristics of participants|
Mean age : 44.9
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0
|In the register|
Change from Baseline to Day 11 in SARS-CoV-2 Viral Load
|In the report|
Change from baseline in the SARS-CoV-2 viral load at day 11 (±4 days) after positive results on testing.
Yes. In English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
In addition to the published article, the trial registry, protocol, statistical plan, supplementary materials and response from contact with authors were used in data extraction and assessment of risk of bias. The published report was a preplanned interim analysis of patients randomized to receive one of three doses of LY-CoV555 (also known as LY3819253) and placebo. The pre-stated sample sizes for these arms were reached. Additional arms in which patients are randomized to receive and combination of LY3819253 and LY3832479 are ongoing. There were some differences in the outcomes included in the trial registry and protocol and the published article. There were no differences in study treatments.
This study was updated on December 29th with data received from contact with authors. The study was updated by Gotleib 2021 for all outcomes except hospitalization or death. We consider Gotleib as the updated report except for the outcome hospitalization or death that will be collected from this study.