What side effects are associated with this type of intervention?

Common treatments for COVID-19 include hydroxychloroquine, remdesivir, interleukin-6 inhibitors, and dexamethasone. Hydroxychloroquine has been associated with cardiac arrhythmias and other cardiovascular issues. Remdesivir can cause liver enzyme elevations and gastrointestinal symptoms like nausea. Interleukin-6 inhibitors may lead to increased risk of infections and liver enzyme abnormalities. Dexamethasone, a corticosteroid, can cause psychiatric side effects such as depression, emotional lability, and insomnia, as well as other issues like hyperglycemia and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19. Remdesivir, an antiviral agent, is approved for both hospitalized and nonhospitalized patients aged 28 days and older who weigh at least 3 kg. Monoclonal antibodies, such as bebtelovimab, were authorized for use but have variable activity against different SARS-CoV-2 variants and are no longer authorized in the U.S. due to the prevalence of resistant variants. Additionally, the combination of tixagevimab and cilgavimab (Evusheld) has been approved for pre-exposure prophylaxis in immunocompromised individuals.

What other types of research exist?

Promising novel alternatives for COVID-19 treatment in 2024 include advanced antiviral drugs, updated vaccines, monoclonal antibody treatments, and convalescent plasma therapy. Additionally, nanoparticle-based therapeutic approaches are being explored. Collaboration between drug developers, academics, and regulators is crucial for optimizing dosing and ensuring the safe and effective use of these treatments across different patient subgroups.

← Back to Search

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

Must not have

Known moderate or severe heart failure, per treating clinician, defined as New York Heart Association (NYHA) class III or IV; known or suspected active tuberculosis; known hypersensitivity to infliximab for Infliximab

Receiving one of the study drugs at time of enrolment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests various drugs on hospitalized COVID-19 patients to see if they work better than standard treatments. The drugs aim to reduce inflammation, block harmful proteins, or kill viruses. Remdesivir has been studied extensively for its antiviral properties and was initially developed for treating Ebola virus.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have severe heart failure, tuberculosis, or allergies to infliximab.

Select...

I am currently taking a medication that is part of this study.

Select...

I am taking steroids for a reason other than COVID-19.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Randomization Dex- Clinical Status

Randomization LSALT- Respiratory support

Randomization WHO- Mortality

Secondary study objectives

Evaluation of the clinical effectiveness of study drugs

Mortality

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Dexamethasone

2007

Completed Phase 4

~2650

Imatinib

2011

Completed Phase 3

~3940

Infliximab

2017

Completed Phase 4

~3350

Artesunate

2005

Completed Phase 4

~3930

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for COVID-19 include antiviral medications, such as remdesivir, which inhibit viral replication by targeting the viral RNA polymerase. Anti-inflammatory drugs, like dexamethasone, reduce the excessive immune response that can lead to severe lung damage. Supportive therapies, including oxygen supplementation and mechanical ventilation, help manage respiratory symptoms and maintain adequate oxygen levels. These treatments are crucial for COVID-19 patients as they address both the viral infection and the body's inflammatory response, improving survival rates and reducing the severity of symptoms.

A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.Evidence and the Main Adverse Effects Regarding Drug Therapies in the War Against COVID-19.[Reducing the impact of COVID-19 on radiation oncology units of developing countries: A rapid review and expert consensus].