COVID-19 Therapeutic Biologic for COVID-19
(COVSP-BCG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with moderate COVID-19 who also have controlled cancer. Researchers are testing a special biologic therapy, COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection, to determine if it can help the immune system fight COVID-19 by directly targeting the virus. The treatment aims to activate the body's defense system against the virus. Ideal participants have controlled cancer and experience moderate COVID-19 symptoms, such as shortness of breath during activity but not severe illness. As an Early Phase 1 trial, this study seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this novel therapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that the COVID-19 treatment called Spike-GM-CSF Protein Lactated Ringer's Injection is just beginning human testing. As a result, limited safety information is available. In these early tests, only a small number of people receive the treatment to observe their body's response and identify any potential side effects.
Past studies of similar treatments have reported common side effects, such as mild reactions like redness or swelling at the injection site. Serious side effects are rare but possible. These early trials guide researchers on what to monitor in larger studies.
Currently, it is too early to determine how well people tolerate this specific treatment. However, any serious safety issues would likely halt development. Always consult a healthcare provider for personalized advice about joining a clinical trial.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the COVID-19 Therapeutic Biologic because it introduces a novel approach to treating COVID-19. Unlike standard treatments like antivirals or monoclonal antibodies, this therapy uses a Spike-GM-CSF protein, combined with lactated Ringer's injection, potentially enhancing the immune response. The unique aspect of this biologic is its mechanism of action, which involves integrating the NOVAVAX COVID-19 vaccine with a BCG organism, aiming to boost the body's ability to fight the virus. This innovative combination could offer a fresh angle on managing COVID-19 by potentially providing a more robust and targeted immune activation.
What evidence suggests that this treatment might be an effective treatment for COVID-19?
Research has shown that COVID-19 Therapeutic Biologics, such as the Spike-GM-CSF Protein Lactated Ringer's Injection, are designed to help the body combat COVID-19 by strengthening the immune system. This trial will evaluate the activity of this therapeutic biologic. The treatment activates certain cells that enable the immune system to recognize and destroy the virus. Early results suggest this method could be effective, as it helps the body identify and eliminate the COVID-19 virus more efficiently. The Spike-GM-CSF component may further enhance the immune response by improving the immune system's ability to detect viral proteins. Although direct human data is limited, this approach builds on promising techniques used in developing other COVID-19 vaccines.13456
Who Is on the Research Team?
HAN XU, MD/PhD/FAPCR
Principal Investigator
Medicine Invention Design, Inc. (MIDI) - IORG0007849
HAN XU, MD/PhD/FAPCR
Principal Investigator
Medicine Invention Design, Inc. (MIDI) - IORG0007849
HAN XU, MD/PhD/FAPCR
Principal Investigator
Medicine Invention Design, Inc. (MIDI) - IORG0007849
Are You a Good Fit for This Trial?
This trial is for people with moderate COVID-19 confirmed by standard tests, experiencing symptoms like shortness of breath or increased heart rate. They must have an oxygen saturation over 93% without assistance and not be severely ill. Pregnant or breastfeeding individuals, those with serious illnesses, allergies, bleeding tendencies, or prohibited from using biologics cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the NOVAVAX COVID-19 Vaccine 1.0 mL plus BCG Organism 50 MG Mix via percutaneous route
Follow-up
Participants are monitored for safety and effectiveness after treatment, including IGRA blood tests and COVID-19 nucleic acid testing
What Are the Treatments Tested in This Trial?
Interventions
- COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair
Lead Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Lead Sponsor
PPD DEVELOPMENT, LP
Industry Sponsor
David Simmons
PPD DEVELOPMENT, LP
Chief Executive Officer since 2012
BSc in Applied Science from Georgia Institute of Technology
Martina Flammer
PPD DEVELOPMENT, LP
Chief Medical Officer since 2024
MD
PPD Development, LP
Industry Sponsor
UnitedHealthcare
Collaborator
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University