Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection (ALI)
|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: NCT04526912|
Recruitment Status : Recruiting
First Posted : August 26, 2020
Last Update Posted : September 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Lung Injury||Drug: VIB7734 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Proof of Concept Study of the Safety and Efficacy of VIB7734 for the Treatment and Prevention of Acute Lung Injury (ALI) in Patients With SARS-CoV-2 Infection|
|Actual Study Start Date :||August 28, 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||March 2021|
Experimental: VIB7734 Dose
Participants will receive a single subcutaneous dose of VIB7734.
Single subcutaneous dose
Placebo Comparator: Placebo
Participants will receive a single subcutaneous dose of placebo (saline) matched to single dose of VIB7734.
Intravenous single dose matched to VIB7734.
- The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness [ Time Frame: Day 1 (Baseline) through Day 28 ]Critical illness is defined by respiratory failure (requiring any of the following: endotracheal intubation, oxygen delivered by high flow nasal cannula, non-invasive positive pressure ventilation, extracorporeal membrane oxygenation or clinical diagnosis of respiratory failure) or shock (systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg, or requiring vasopressors)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent fatal and life-threatening SAEs, Treatment-emergent Serious Adverse Events [ Time Frame: Day 1 (Baseline) through Day 70 ]Defined as measure of safety
- Change in safety laboratory parameters [ Time Frame: Day 1 (Baseline) through Day 70 ]Safety evaluation via review of labs (white blood cell (WBC) with differential counts, hemoglobin, platelet count, liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and total bilirubin levels), serum chemistry, cardiac troponin coagulation markers (prothrombin time [PT], partial thromboplastin time [PTT], D dimer, fibrinogen), and urinalysis)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526912
|Contact: Gábor Illei, MD, PhD, MHS||240-920-0072||IlleiG@VielaBio.com|
|Contact: Daniel Falleroni||240-356-4437||FalleroniD@VielaBio.com|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Study Director:||Gábor Illei, MD, PhD, MHS||Vice President, Clinical Development Lead|