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Here's the ongoing Phase 3 - Humanigen - >>> Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia


https://clinicaltrials.gov/ct2/show/NCT04351152


The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.


ClinicalTrials.gov Identifier: NCT04351152
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : June 11, 2020
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Sponsor:

Humanigen, Inc.
Information provided by (Responsible Party):
Humanigen, Inc.


Study Description
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Brief Summary:

The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care (SOC) can alleviate the immune-mediated cytokine release syndrome (CRS) and prevent progression to respiratory failure and/or death in high risk patients with COVID-19 pneumonia.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 (COVID-19) Pneumonia
Biological: Lenzilumab
Drug: Standard of Care
Phase 3

Detailed Description:

Most deaths in COVID-19 patients result from respiratory distress, which appears to be driven in large part by a CRS mediated hyper-immune reaction ('cytokine storm') that may occur even in patients who appear to be resolving their infection by viral titers. In addition, GM-CSF+T cells are highly correlated with severity and ICU admission in the setting of COVID-19. For this reason, it is critical to intervene prior to the initiation of CRS and severe respiratory distress in patients at high risk of progression. This phase 3 randomized, multicenter, placebo-controlled clinical trial will evaluate the impact of GM-CSF neutralization with lenzilumab on incidence of respiratory failure and/or death in patients with COVID-19 pneumonia upon hospitalization. 238 patients will be randomized to receive lenzilumab + SOC vs. SOC in a 1:1 ratio. An interim analysis is planned for DSMB to assess safety & efficacy data.

Study Design
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Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia
Actual Study Start Date : April 30, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

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