The main purpose of TICO is to learn if new, investigational treatments are safe and can help people in the hospital with COVID-19 get better and go home faster. The experimental medicines in TICO are anti SARS-CoV-2 monoclonal antibodies, which bind to the virus and prevent it from entering your body’s cells. Study medications must have, at the least, been previously studied in healthy volunteers. One of the main objectives of this study is to investigate the safety of the product, as well to see whether it works in helping in the recovery of people from COVID-19.
Currently, TICO is conducting two randomized, controlled Phase 3 sub-studies evaluating investigational monoclonal antibodies for their safety and efficacy in treating people hospitalized with mild to moderate COVID-19. The trials are part of the ACTIV-3 master protocol. One sub-study is evaluating VIR-7831, a monoclonal antibody developed through a partnership between GlaxoSmithKline (Brentford, United Kingdom) and Vir Biotechnology, Inc. (San Francisco). The other sub-study is evaluating the combination of BRII-196 and BRII-198, two neutralizing monoclonal antibodies manufactured by Brii Biosciences (Durham, NC, and Beijing).
What does the study involve?
Participants in the new ACTIV-3 sub-studies will share a control group and be randomized 1:1:1 to receive either a saline placebo control, VIR-7831 or the Brii combination. In other words, two-thirds of people who enter the study will receive one of the two experimental anti SARS-CoV-2 monoclonal antibodies. One-third of the participants will receive a placebo.
Participants will be randomly assigned to a study group. Neither the study team nor the study participants will know who is receiving study drug and who is receiving placebo. Participants will not be able to choose their group, and neither the participant, study doctor, nor the study staff at the site will know which group a participant is in. All participants will receive standard of care treatment, including remdesivir, if their doctor feels it is appropriate.
You will be told of any new information learned during the course of the study that might cause you to change your mind about staying in the study. You can choose to drop out of the study, for any reason, at any time. At the end of the study, you will be told when study results may be available and how to learn about them. If we find out important information that may affect your care, you will be provided with those results.
Initially, researchers will enroll approximately 450 volunteers (150 per group) who have been hospitalized with mild-to-moderate COVID-19 with fewer than 13 days of symptoms. After five days, the participants’ medical condition will be assessed on two 7-point ordinal scale. Eventually, a total of 1500 people will join the TICO studies to learn if the study drugs can get people home from the hospital sooner for at least 14 days. More people will be added to the study as additional investigational products are added.
Volunteers who have been hospitalized with mild-to-moderate COVID-19 with fewer than 13 days of symptoms can join the TICO study. You cannot have received convalescent plasma or COVID-19 monoclonal antibody treatment before you enter the study. You cannot join the study if you are already severely ill with COVID-19 requiring high flow oxygen or mechanical ventilation.
Is there a cost?
There will be no cost for study-related visits or procedures.
Is compensation provided?
Participants will be provided with compensation for their time and inconvenience, the amounts vary by location. During the consent process, the study team will review specific reimbursement items for their location.
Number of visits
There will be 11 total visits, some in person and some by phone.
Your time in the hospital would be the same as if you were not in the study, but there will be multiple outpatient or at home visits afterward you leave the hospital. During this time, we will check to see if you are okay and to collect more information to help us understand the drug effects. These visits, with your permission, might involve someone coming to your home.
Steps to participate
Please check whether the hospital you plan to be admitted to is taking part in this study. If you provide us with your current location, we can let you know the closest hospitals in your area that offer the study.
Once you are at the hospital site, the staff will describe the next steps including the consent process, the study visit schedule, and what happens at each study visit. They will check that you meet all the requirements for the study and conduct a few assessments (e.g., blood draw).
Visit ClinicalTrials.gov for details.
If interested in participating in this study, please send an email to firstname.lastname@example.org with the subject line ACTIV-3.
Do not include personal information in your email.