RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection

Summary

Vapendavir (VPV) is a drug being developed to treat human rhinovirus (RV) infection, one virus responsible for the common cold. Vapendavir prevents the virus from entering cells and making more infectious copies of itself. A study is being planned to investigate VPV in patients with chronic obstructive pulmonary disease (COPD, a lung disease making it difficult to breathe) who develop a rhinoviral infection; however, VPV has not been approved for use in treating any indication (disease) by the FDA or any other global regulatory agency. Therefore, VPV is considered investigational, and the study doctor is conducting this investigational research study. Safety will be monitored throughout the entire study.

Conditions

• COPD Exacerbation Acute
• COPD With Acute Lower Respiratory Infection
• Rhinovirus
• Virus Diseases
• Virus Infection, RNA
• Enterovirus
• Enterovirus Infections
• Rhinovirus Infection
• Infection Viral
• Respiratory Complication
• Respiratory Disease
• Respiratory Tract Infections
• Respiratory Tract Diseases
• Respiratory Viral Infection
• Upper Resp Tract Infection
• Upper Respiratory Tract Infections
• Upper Respiratory Disease
• Upper Respiratory Disorder
• Upper Respiratory Disease, Acute
• Upper Respiratory Infection Viral
• Infections, Respiratory
• Infections
• Copd
• Viral Infection
• Emphysema or COPD
• Lower Respiratory Disease
• Lower Respiratory Disorder
• Lower Respiratory Tract and Lung Infections
• Pulmonary Disease
• Pulmonary Disease, Chronic Obstructive
• Respiratory Disease Chronic
• Lung Diseases
• Lung Disease Chronic
• Obstructive Pulmonary Disease
• Chronic Lower Respiratory Diseases
• Chronic Respiratory Disease

Interventions

DRUG

Vapendavir

Participants randomized to the experimental cohort will be administered Vapendavir.

DRUG

Placebo

Participants randomized to the placebo cohort will be administered placebo.

Sponsors & Collaborators

• Virtus Respiratory Research

  collaborator UNKNOWN

• Altesa Biosciences, Inc.

  lead INDUSTRY

Principal Investigators

• Onn Min Kon, MD · Imperial College Healthcare

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-20

Primary Completion

2025-03-30

Completion

2025-03-30

FDA Drug

Yes

Countries

• United Kingdom

Study Locations