An Exploratory Study to Describe Virological Effect, Safety, and Pharmacokinetics of VIR-7831 Monoclonal Antibody in Hospitalized Participants With COVID-19

COVID-19 Clinical Trial

— COMET-ACE  

Official title:

An Exploratory, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Study to Describe the Virological Effect, Safety, and Pharmacokinetics of a Single Intravenous (IV) Dose of VIR-7831 Monoclonal Antibody in Hospitalized Participants With Coronavirus Disease 2019 (COVID-19)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04766671
• Other study ID #: 214366
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 14, 2021
• Est. completion date: June 8, 2022

Study information

• Verified date: February 2021
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an exploratory study in which hospitalized participants with COVID-19 will receive VIR-7831 (GSK4182136) or matching placebo with assessments of virological effect, safety and pharmacokinetics (PK). The study will be comprised of two phases: The Lead-in phase and the Expansion phase.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 8, 2022
• Est. primary completion date: August 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older.
• Have a positive SARS-CoV-2 test result within 3 days prior to randomization OR have a positive SARS-CoV-2 test result more than 3 days prior to randomization AND clinical status suggestive of ongoing SARS-CoV-2 infection per the responsible investigator.
• Duration of symptoms attributable to COVID-19 of =< 12 days of Day 1 per the responsible investigator.
• Required admission to the hospital as an inpatient for the management and/or treatment of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes. Hospitalization can include, but does not require, admission or transfer to the intensive care unit (ICU).
• In those already hospitalized, at the time of randomization, requiring continued acute medical care in the hospital for the management and/or treatment of COVID-19 as per the judgement of the responsible investigator. This excludes participants who are in the hospital awaiting placement in a lower level facility or for initiation of home health services prior to discharge.
• No gender restriction.
• A female participant is eligible to participate if she is not pregnant or breastfeeding or if she is using highly effective contraceptive methods. Women of non-childbearing potential can also participate. A negative highly sensitive pregnancy test at hospital admission or before the first dose of study intervention.
• Capable of giving signed or oral informed consent as described in protocol. If participants are not capable of giving written informed consent, alternative consent procedures will be followed as detailed in protocol.

Exclusion Criteria:

• In the opinion of the responsible investigator, any condition for which participation would not be in the best interest of the participant, or that could limit protocol-specified assessments.
• Expected inability to participate in study procedures.
• Participants who, in the opinion of the investigator, are not likely to survive beyond 48 hours at the time of randomization.
• Planned or anticipated discharge or transfer to another hospital within 72 hours at the time of randomization.
• History of hypersensitivity to other monoclonal antibodies (mAbs) or any of the excipients present in the investigational product.
• Prior receipt of: Any SARS-CoV-2 hyperimmune intravenous immunoglobulin (hIVIG) from COVID-19 survivors; Convalescent plasma from a person who recovered from COVID-19 or SARS-CoV-2 neutralizing mAbs at any time.
• Participating in other clinical trials involving an investigational study intervention, including for COVID-19.
• Pregnant or breast-feeding females.

For Lead-in Phase only:

• Participants with end organ failure or dysfunction are not eligible for Lead-in phase but are eligible for Expansion-Phase.
• End-organ dysfunction categories are: stroke, meningitis, encephalitis, myelitis, myocardial infarction, myocarditis, pericarditis, symptomatic congestive heart failure (New York Heart Association [NYHA] class III-IV), arterial or deep venous thrombosis or pulmonary embolism.
• End-organ failure categories are: requirement for high-flow oxygen, non-invasive ventilation, or invasive mechanical ventilation; extracorporeal membrane oxygenation (ECMO); mechanical circulatory support (e.g., intra-aortic balloon pump, ventricular assist device); vasopressor therapy; commencement of renal replacement therapy (RRT) during this admission (i.e. not participants on chronic RRT).

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• VIR-7831
Eligible participants will receive VIR-7831
• Placebo
Eligible participants will receive matching placebo

Drug:
• Standard of care
All the participants will receive SoC along with study treatment as based on institutional/local protocols (e.g, remdesivir, dexamethasone)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Vir Biotechnology, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in viral load as measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from nasopharyngeal (NP) swabs		Baseline and up to Day 29
Secondary	Change from Baseline in viral load as measured by qRT-PCR from tracheal aspirate (TA) or endotracheal tube aspirate (ET) or spontaneous sputum (SS) samples and saliva samples		Baseline and up to Day 29
Secondary	Change from Baseline in viral load as measured by quantitative culture from NP swabs		Baseline and up to Day 29
Secondary	Time (in days) to achieve undetectable Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2) from TA or ET or SS samples, NP swabs and saliva samples using qRT-PCR		Up to Day 29
Secondary	Maximum observed serum concentration (Cmax) of VIR-7831		Up to Day 29
Secondary	Area under the plasma concentration-time curve from time 0 to Day 29 (AUC 0-Day 29) of VIR-7831		Up to Day 29
Secondary	Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)		Up to 48 weeks
Secondary	Number of participants with clinically significant changes in vital signs, laboratory parameters and 12-lead electrocardiogram (ECG) findings		Up to 48 weeks