COVID-19Phase 2NCT04342897
A Study of LY3127804 in Participants With COVID-19
A Phase 2 study testing LY3127804 in people with COVID-19 and Pneumonia, run by Eli Lilly and Company at 13 sites in United States.
Trial summary
A randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants who are hospitalized with pneumonia and presumed or confirmed COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- LY3127804
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 13 sitesUnited States
- Study dates
- 20 Apr 2020to 12 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Nuvance Danbury Hospital
Danbury, Connecticut, 06810
National Jewish Medical and Research Center
Denver, Colorado, 80206
Henry Ford Hospital Detroit
Detroit, Michigan, 48202-2689
NorthShore University HealthSystem
Evanston, Illinois, 60201
Parkview Research Center
Fort Wayne, Indiana, 46845
East Carolina University
Greenville, North Carolina, 27834
Franciscan St. Francis Health
Indianapolis, Indiana, 46237
Allina Hospital Network
Minneapolis, Minnesota, 55404
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Banner Univ Med Ctr Phoenix
Phoenix, Arizona, 85006
State University of New York Hospital
Syracuse, New York, 13210
Banner Univ Med Ctr Tucson
Tucson, Arizona, 85719
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Clinical Trial of LY3127804 in Patients Who Are Hospitalized With Pneumonia and Presumed or Confirmed COVID-19
A randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants who are hospitalized with pneumonia and presumed or confirmed COVID-19.
- Being tested
- LY3127804, Placebo
- Keywords
- Corona Virus Disease 19 (COVID-19), 2019 Novel Coronavirus (2019 n-COV), Severe Acute Respiratory Syndrome (SARS), Pulmonary Disease, SARS-CoV-2
- Medical subject headings
- COVID-19, Pneumonia, Severe Acute Respiratory Syndrome, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3127804Drug
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY3127804 | Experimental | Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15. Receives: Drug: LY3127804 |
| Placebo | Placebo comparator | Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator Free Days
Ventilator-free days were defined as the number of days from Day 1 through Day 28 on which a participant breathed without assistance, if the period of unassisted breathing lasted at least 24 consecutive hours and the participant did not die within 28 days from the first dose of the study drug.
Measured: Day 1 through Day 28
Secondary outcomes (6)
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
The NIAID ordinal scale clinical status was defined as the lowest score achieved for that day, the lowest NIAID score from Day 1 through Day 28 for each participant was reported. NIAID ordinal assessment levels are reported by using the following 8 point scale, where a higher score is a better outcome: 1) death, 2) hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO), 3) hospitalized, on non-invasive ventilation or high-flow oxygen devices, 4) hospitalized, requiring supplemental oxygen, 5) hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19-related or otherwise), 6) hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care, 7) not hospitalized, limitation on activities and/or requiring home oxygen, and, 8) not hospitalized, no limitations on activities.
Measured: Day 1 through Day 28
Percentage of Participants With Complete Response
Complete response was defined as being alive and never requiring mechanical ventilator support (at any point while on study) through Day 28.
Measured: Day 1 through Day 28
Number of Participants Who Died Between Day 1 Through Day 28
Measured: Day 1 through Day 28
Length of Hospitalization
Days of participants hospitalization.
Measured: Day 1 through Day 28
Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)
An SAE is any AE from this study that results in one of the following outcomes: death that is not related to COVID-19 or a sequela of COVID-19 or death that is considered by the investigator to be related to study drug, prolonged inpatient hospitalization or re-hospitalization life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other SAE outcomes.
Measured: Day 1 through Day 60
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
TEAE was defined as any untoward medical occurrence that emerges during a defined treatment period, having been absent pre-treatment, or worsens relative to the pretreatment state, and does not necessarily had a causal relationship with the study treatment.
Measured: Day 1 through Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start20 Apr 2020
- Primary completion12 Oct 2020
- Study completion12 Oct 2020
Why it stopped: Trial terminated for futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342897
- Sponsor's protocol ID
- 17824
- Other IDs
- I7W-MC-UDAA
- Status last verified
- Aug 2021
- First submitted
- 10 Apr 2020
- Last updated
- 12 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
Publications
Jones RS, Smith PS, Berg PH, de la Pena A, Cook PP, Shawa I, Kioussopoulos KM, Hu Y, Schott RJ. Efficacy and Safety of LY3127804, an Anti-Angiopoietin-2 Antibody, in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Patients Hospitalized with Pneumonia and Presumed or Confirmed COVID-19. Clin Med Insights Circ Respir Pulm Med. 2022 Aug 10;16:11795484221119316. doi: 10.1177/11795484221119316. eCollection 2022.
PubMed 35991210
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Clinical Trial of LY3127804 in Patients Who Are Hospitalized With Pneumonia and Presumed or Confirmed COVID-19
- ClinicalTrials.gov ID
- NCT04342897
- Acronym / sponsor ID
- 17824
- Keywords
- Corona Virus Disease 19 (COVID-19), 2019 Novel Coronavirus (2019 n-COV), Severe Acute Respiratory Syndrome (SARS), Pulmonary Disease, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial terminated for futility.
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Posted 12 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants who are hospitalized with pneumonia and presumed or confirmed COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3127804 | Experimental | Drug: LY3127804Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3127804Administered IV | Drug | LY3127804 |
| PlaceboAdministered IV | Drug | Placebo |
Primary outcome
Ventilator Free Days
Time frame: Day 1 through Day 28
Ventilator-free days were defined as the number of days from Day 1 through Day 28 on which a participant breathed without assistance, if the period of unassisted breathing lasted at least 24 consecutive hours and the participant did not die within 28 days from the first dose of the study drug.
6 secondary outcomes
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
Time frame: Day 1 through Day 28
Percentage of Participants With Complete Response
Time frame: Day 1 through Day 28
Number of Participants Who Died Between Day 1 Through Day 28
Time frame: Day 1 through Day 28
Length of Hospitalization
Time frame: Day 1 through Day 28
Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)
Time frame: Day 1 through Day 60
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
Time frame: Day 1 through Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35991210Jones RS, Smith PS, Berg PH, de la Pena A, Cook PP, Shawa I, Kioussopoulos KM, Hu Y, Schott RJ. Efficacy and Safety of LY3127804, an Anti-Angiopoietin-2 Antibody, in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Patients Hospitalized with Pneumonia and Presumed or Confirmed COVID-19. Clin Med Insights Circ Respir Pulm Med. 2022 Aug 10;16:11795484221119316. doi: 10.1177/11795484221119316. eCollection 2022.
- A Study of LY3127804 in Participants With COVID-19Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY3127804 in people with COVID-19 and Pneumonia, run by Eli Lilly and Company at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator Free Days (time frame: Day 1 through Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04342897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.