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Monoclonal Antibodies

BRII-196/BRII-198 for Coronavirus (TICO Trial)

Phase 3
Waitlist Available
Led By Prof. Jens Lundgren
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

TICO Trial Summary

This trial looks at the safety and effectiveness of different drugs in treating COVID-19 in hospitalized patients.

Eligible Conditions
  • Coronavirus

TICO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time from randomization to sustained recovery
Secondary outcome measures
All-cause mortality
Change in SARS-CoV-2 neutralizing antibody levels
Change in neutralizing antibody levels
+13 more

TICO Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ACTIV-3 Drug plus SOCExperimental Treatment7 Interventions
Participants in this study will be randomized to receive one of the ACTIV-3 drug treatments plus Standard of Care (SOC) or placebo plus SOC
Group II: Placebo plus SOCPlacebo Group2 Interventions
The placebo arm may be pooled across more than one experimental arm if multiple investigational drugs are available to be tested at the same time. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remdesivir
2020
Completed Phase 3
~21440
BRII-196/BRII-198
2020
Completed Phase 3
~2760
LY3819253
2020
Completed Phase 3
~6430
PF-07304814
2020
Completed Phase 3
~2800
MP0420
2021
Completed Phase 3
~3240
VIR-7831
2020
Completed Phase 3
~4880
AZD7442
2020
Completed Phase 3
~6640

Find a Location

Who is running the clinical trial?

Cardiothoracic Surgical Trials NetworkOTHER
8 Previous Clinical Trials
3,571 Total Patients Enrolled
Prevention and Early Treatment of Acute Lung InjuryOTHER
8 Previous Clinical Trials
3,571 Total Patients Enrolled
University of MinnesotaOTHER
1,378 Previous Clinical Trials
1,585,756 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are included in this research?

"This study is no longer recruiting patients for participation. The trial was originally posted on August 4th, 2020 and was last updated on August 26th, 2020. However, there are 1134 other studies actively recruiting patients with covid-19 and 18 trials for BRII-196/BRII-198 that are still enrolling participants."

Answered by AI

What are the primary indications for BRII-196/BRII-198?

"Patients with a spo2 level at or below 94%, who are currently hospitalized, and have been diagnosed with coronavirus disease 2019 may be eligible to receive BRII-196/BRII-198."

Answered by AI

Are there other instances in which BRII-196/BRII-198 have been researched?

"BRII-196/BRII-198 was first studied in 2020 at Island Health - Victoria General Hospital. There have been a total of 18316 completed studies as of now. Additionally, there are 18 live studies being conducted with many of them taking place in Winston-Salem, North carolina."

Answered by AI

How many total sites are testing this new therapy?

"There are 100 total sites for this trial, with locations including UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St. in Winston-Salem, Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd in Pittsburgh, and UPMC Presbyterian Hospital (Site 209-001), 200 Lothrop Street in Roanoke, among others."

Answered by AI

What is the FDA's stance on BRII-196/BRII-198?

"BRII-196/BRII-198 has been given a safety rating of 3. This is based off the fact that it is currently in Phase 3 trials, which suggests that not only does this medication show some efficacy, but also that there are multiple rounds of data supporting its safety."

Answered by AI

Are investigators still looking for participants for this research project?

"This study is not currently looking for new patients, as evident from the clinicaltrials.gov listing which was last updated on 8/26/2022. Although this trial isn't enrolling, there are 1,152 other trials that are still recruiting patients."

Answered by AI

Have similar studies been conducted before?

"There are 442 cities and 40 countries with ongoing clinical trials for BRII-196/BRII-198. The first study, which was sponsored by AbbVie in 2020, completed Phase 3 drug approval after 2900 patients were enrolled. In the two years since, a total of 18316 studies have been conducted."

Answered by AI

Who else is applying?

What state do they live in?
New York
Other
Indiana
Florida
How old are they?
18 - 65
What site did they apply to?
Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Had corona virus 3 weeks ago.
PatientReceived no prior treatments
Recent research and studies
~590 spots leftby Apr 2025