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ARBs

Multiple Treatments for COVID-19 (CATCO Trial)

Phase 3

Waitlist Available

Led By Srinivas Murthy, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary reason for hospitalization or subsequent in-hospital illness is because of acute COVID19 infection

≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

CATCO Trial Summary

This trial is testing a new way to do clinical trials that is faster and cheaper.

Who is the study for?

Adults hospitalized with acute COVID-19 infection, confirmed by a lab test within the last 14 days. Participants must be at their first hospital admission for COVID-19 and not expected to transfer to a non-participating center or pass away within 24 hours. Exclusions include known allergies to trial drugs, certain pre-existing conditions, pregnancy, breastfeeding, and current use of study drugs.Check my eligibility

What is being tested?

The trial is testing multiple treatments: Artesunate, Imatinib, Infliximab, Dexamethasone (a steroid), and LSALT Peptide in an adaptive design. Patients are randomly assigned to receive one of these interventions alongside standard care for COVID-19.See study design

What are the potential side effects?

Possible side effects may include allergic reactions specific to each drug; liver issues with Imatinib; heart failure risks with Infliximab; immune system suppression from steroids like Dexamethasone; and general medication-related risks such as nausea or rash.

CATCO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am in the hospital primarily due to COVID-19.

Select...

I am 18 years old or older.

Select...

This is my first hospital visit for COVID-19.

CATCO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

Randomization Dex- Clinical Status

Randomization LSALT- Respiratory support

Randomization WHO- Mortality

Secondary outcome measures

CU admission, hospital and ICU length of stay, days alive and free of vasopressors, ventilation, and renal replacement therapy (RRT

Evaluation of the clinical effectiveness of study drugs

Mortality

+1 more

Other outcome measures

Time to viral clearance of lopinavir/ritonavir as compared to the control arm

CATCO Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: LSALT PeptideExperimental Treatment1 Intervention

Subjects will be randomized between LSALT vs standard of care.

Group II: InfliximabExperimental Treatment1 Intervention

Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care

Group III: ImatinibExperimental Treatment1 Intervention

Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care

Group IV: DexamethasoneExperimental Treatment1 Intervention

Subjects will be randomized between Dexamethasone vs standard of care.

Group V: ArtesunateExperimental Treatment1 Intervention

Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care

Group VI: Control (Standard Care)Active Control1 Intervention

This arm will receive standard supportive care guidelines for COVID-19. It is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Artesunate

2005

Completed Phase 4

~3930

Imatinib

2011

Completed Phase 3

~3940

Infliximab

2017

Completed Phase 4

~3280

Dexamethasone

2007

Completed Phase 4

~2590

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,547,722 Total Patients Enrolled

12 Trials studying COVID-19

7,179 Patients Enrolled for COVID-19

AbbVieIndustry Sponsor

954 Previous Clinical Trials

498,205 Total Patients Enrolled

4 Trials studying COVID-19

1,530 Patients Enrolled for COVID-19

Apotex Inc.Industry Sponsor

8 Previous Clinical Trials

26,120 Total Patients Enrolled

Media Library

ARBs (ARBs) Clinical Trial Eligibility Overview. Trial Name: NCT04330690 — Phase 3

COVID-19 Research Study Groups: Artesunate, Imatinib, Infliximab, Dexamethasone, LSALT Peptide, Control (Standard Care)

COVID-19 Clinical Trial 2023: ARBs Highlights & Side Effects. Trial Name: NCT04330690 — Phase 3

ARBs (ARBs) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04330690 — Phase 3

Frequently Asked Questions

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

Are there any current openings for volunteers in this clinical trial?

"That is accurate. The clinical trial was posted on March 18th, 2020 and is currently looking for 2900 patients at 45 different sites, according to the data available on clinicaltrials.gov"

Answered by AI

What common ailment is ARBs used as a treatment for?

"ARBs are a common course of treatment for patients that weigh between 3.5 and 40 kilograms. Additionally, ARBs may improve quality of life metrics for patients with conditions like low spo2 levels, supplemental oxygen needs, or hospitalization history."

Answered by AI

What is the maximum number of participants for this clinical trial?

"In order to carry out this clinical trial, 2900 eligible individuals are required. These participants must meet the specified inclusion criteria and can come from different parts of Canada including St Paul's Hospital in Vancouver, BC and Thunder Bay Regional Health Sciences Centre in Thunder Bay, ON."

Answered by AI

What other similar trials have been executed in the past?

"ARBs have been researched since 2008. The first trial, which was sponsored by Genentech, Inc., only involved 220 participants. After the success of this initial study, ARBs received its Phase 2 drug approval and today there are 20 active trials in 582 cities and 62 countries."

Answered by AI

What does the FDA have to say about ARBs?

"ARBs have received a score of 3 for safety. This is because ARBs are in Phase 3 trials, meaning that there is both evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

Are there many active research sites for this trial in North America?

"St Paul's Hospital in Vancouver, Thunder Bay Regional Health Sciences Centre in Thunder Bay, Niagara Health in Saint Catharines are 3 of the 45 running clinical trials."

Answered by AI

Do we have a lot of evidence supporting the use of ARBs?

"ARBs were first examined in a clinical setting at CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge back in 2008. Since then, 844 similar trials have been completed with 20 more currently underway. Many of these active studies are based out of Vancouver, Ontario."

Answered by AI