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LY3819253Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)

Name (Synonyms) Correlation
drug2383 Recombinant Human Interferon α2b Spray Wiki 0.50
drug480 Bromhexine Hydrochloride Tablets Wiki 0.50
drug250 Arbidol Hydrochloride Granules Wiki 0.50
drug2991 UC-MSCs Wiki 0.22
drug2413 Remdesivir Wiki 0.11
drug2122 Placebo Wiki 0.10

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.06
D011014 Pneumonia NIH 0.06
D007239 Infection NIH 0.05
D045169 Severe Acute Respiratory Syndrome NIH 0.02

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.06

There are 4 clinical trials

Clinical Trials

1 A Randomized, Placebo-Controlled, Double-Blind, Sponsor Unblinded, Single Ascending Dose, Phase 1 First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous LY3819253 in Participants Hospitalized for COVID-19

The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection into a vein to participants hospitalized with COVID-19. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the hospital or the home.

NCT04411628 COVID-19 Drug: LY3819253 Drug: Placebo

Primary Outcomes

Description: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time: Baseline through Day 60

Secondary Outcomes

Description: PK: AUC of LY3819253

Measure: Pharmacokinetics (PK): Area Under the Concentration-time Curve (AUC) of LY3819253

Time: Baseline through Day 29

Description: PD: Change from Baseline in Viral Load

Measure: Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load

Time: Baseline, Day 29

2 A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3819253 in Participants With Mild to Moderate COVID-19 Illness

The purpose of this study is to measure how well LY3819253 works against the virus that causes COVID-19. LY3819253 will be given to participants with early symptoms of COVID-19, via an injection into a vein. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 weeks and includes one required visit to the study site, with the remainder of assessments performed in the home or by phone.

NCT04427501 COVID-19 Drug: LY3819253 Drug: Placebo

Primary Outcomes

Description: Change from Baseline to Day 11 in SARS-CoV-2 Viral Load

Measure: Change from Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load

Time: Baseline, Day 11

Secondary Outcomes

Description: Change from Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled with Recent Symptoms Prior to Randomization

Measure: Change from Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled with Recent Symptoms Prior to Randomization

Time: Baseline, Day 11

Description: PK: Mean Concentration of LY3819253

Measure: Pharmacokinetics (PK): Mean Concentration of LY3819253

Time: Day 29

Description: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death

Measure: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death

Time: Baseline through Day 29

3 A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 in Preventing SARS-CoV-2 Infection and COVID-19 in Skilled Nursing and Assisted Living Facility Residents and Staff; a NIAID and Lilly Collaborative Study

The purpose of this study is to evaluate whether LY3819253 prevents severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19) in facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure. Participants with a high risk of SARS-CoV-2 exposure will receive LY3819253 or placebo via an injection into a vein. Samples will be taken from the nose. Blood samples will be drawn. Participation could last up to 25 weeks and may include up to 19 visits.

NCT04497987 COVID-19 SARS-CoV2 Drug: LY3819253 Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Percentage of Participants with SARS-CoV-2 Infection

Measure: Percentage of Participants with SARS-CoV-2 Infection

Time: Week 4

Secondary Outcomes

Description: Percentage of Participants with Moderate or Worse Severity COVID-19

Measure: Percentage of Participants with Moderate or Worse Severity COVID-19

Time: Week 8

Description: Percentage of Participants with Mild or Worse Severity COVID-19

Measure: Percentage of Participants with Mild or Worse Severity COVID-19

Time: Week 8

Description: Percentage of Participants Who are Hospitalized due to COVID-19

Measure: Percentage of Participants Who are Hospitalized due to COVID-19

Time: Week 8

Description: Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death

Measure: Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death

Time: Week 8

Description: Percentage of Participants Who Die Due to COVID-19

Measure: Percentage of Participants Who Die Due to COVID-19

Time: Week 8

4 A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

NCT04501978 Covid19 Drug: LY3819253 Drug: Placebo Drug: Remdesivir

Primary Outcomes

Description: Oxygen requirements measured by 7 categories (1 = least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.

Measure: Pulmonary ordinal outcome (Stage 1)

Time: Day 5

Description: Extrapulmonary complications and respiratory dysfunction measured by 7 categories (1= least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.

Measure: Pulmonary+ ordinal outcome (Stage 1)

Time: Day 5

Description: Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.

Measure: Time from randomization to sustained recovery (Stage 2)

Time: Up to Day 90

Secondary Outcomes

Measure: All-cause mortality

Time: Thru Day 90

Measure: Composite of time to sustained recovery and mortality

Time: Thru Day 90

Measure: Days alive outside short-term acute care hospital

Time: Up to Day 90

Description: Oxygen requirements measured by 7 categories (1 = least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.

Measure: Pulmonary ordinal outcome

Time: Days 1-7, 14 and 28

Description: Extrapulmonary complications and respiratory dysfunction measured by 7 categories (1= least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.

Measure: Pulmonary+ ordinal outcome

Time: Days 1-7

Description: Total of: Respiratory rate (breaths per minute) scored from 0 to +3; Oxygen saturation (%) scored from 0 to +3; Any supplemental oxygen scored from 0 to +2; Temperature scored from 0 to +3; Systolic BP scored from 0 to +3; Heart rate (beats per minute) scored from 0 to +3.; and AVPU (alert, voice, pain, unresponsive) scored from 0 to +3. A higher score denotes a worse outcome.

Measure: Change in New Early Warning (NEW) Score

Time: Baseline to Day 5

Measure: Incidence of clinical organ failure

Time: Thru Day 28

Measure: Composite of death or serious clinical COVID-19 related events

Time: Thru Day 90

Measure: Composite of cardiovascular events and thromboembolic events

Time: Thru Day 90

Measure: Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death

Time: Thru Days 5 and 28

Measure: Incidence of infusion reactions

Time: Thru Day 0

Measure: Composite of SAEs or death

Time: Thru Day 90

Measure: Change in SARS-CoV-2 neutralizing antibody levels

Time: Baseline to Days 1, 3, 5, 28 and 90

Measure: Change in overall titers of antibodies

Time: Baseline to Days 1, 3, 5, 28 and 90

Measure: Change in neutralizing antibody levels

Time: Baseline to Days 1, 3, 5, 28 and 90

No related HPO nodes (Using clinical trials)