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Multiple Therapies for COVID-19

Phase 2

Waitlist Available

Research Sponsored by Lisa Barrett

Eligibility Criteria Checklist

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

Must have

18 years or older

Moderate to severe COVID-19 associated disease as defined by the WHO

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 180 days

Awards & highlights

Study Summary

This trial will test if an investigational medication is safe and effective when used alongside the clinical standard of care treatment for people hospitalized with moderate to severe COVID-19 disease.

Who is the study for?

This trial is for hospitalized adults with moderate to severe COVID-19, confirmed by a test. Participants must have lung issues or need oxygen support but can't join if they have certain liver problems, untreated TB, active hepatitis B/C, recent serious infections, are pregnant/breastfeeding, or have severe kidney disease.Check my eligibility

What is being tested?

The study tests Tocilizumab (blocks inflammation), Remdesivir (antiviral) alone or with Baricitinib (reduces immune response), alongside standard care. It aims to see how well these treatments work and their safety in different severity levels of COVID-19 patients.See study design

What are the potential side effects?

Possible side effects include allergic reactions to the drugs; increased risk of infection; liver enzyme elevations; potential heart rhythm problems from Baricitinib; and infusion-related reactions from Tocilizumab.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have moderate to severe COVID-19 according to WHO standards.

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My condition requires oxygen but not ICU-level care, or I need ICU care due to severe symptoms.

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My potassium, magnesium, and calcium levels are normal before starting treatment.

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I have lung issues, need oxygen, or am on a ventilator.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical status of subject at day 15 (on a 7 point ordinal scale).

Secondary outcome measures

Adverse events

Cause of death (if applicable)

Duration of hospitalization

+10 more

Other outcome measures

Global and SARS-CoV-2-specific immune responses before, during and after intervention and in standard of care treatment arm

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: TocilizumabExperimental Treatment1 Intervention

Severe, critical disease

Group II: Remdesivir + baricitinibExperimental Treatment1 Intervention

Moderate and severe, not critical disease

Group III: RemdesivirExperimental Treatment1 Intervention

Moderate and severe, not critical disease

Group IV: BaricitinibExperimental Treatment1 Intervention

Moderate and severe, not critical disease

Group V: Clinical standard of careActive Control1 Intervention

Moderate and severe, not critical disease AND severe, critical disease as applicable

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dalhousie UniversityOTHER

169 Previous Clinical Trials

403,291 Total Patients Enrolled

Lisa BarrettLead Sponsor

2 Previous Clinical Trials

74 Total Patients Enrolled

Nova Scotia Health AuthorityOTHER

262 Previous Clinical Trials

84,499 Total Patients Enrolled

3 Trials studying COVID-19

1,042 Patients Enrolled for COVID-19

Frequently Asked Questions

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

Has the FDA authorized use of Remdesivir as a therapeutic agent?

"Although there is some safety evidence from Phase 2 trials, no efficacy data has been documented yet. Therefore, our team at Power assigned Remdesivir a score of 2 on the risk scale."

Answered by AI

Are there any other investigations into the efficacy of Remdesivir (antiviral) as a treatment?

"Currently, 31 clinical studies are underway to assess the efficacy of Remdesivir (antiviral), 15 of which have progressed to Phase 3. While most trials for this antiviral drug take place in Pune, Maharashtra, there is an impressive total of 1416 sites researching its effects."

Answered by AI

Is enrollment currently open for this experiment?

"This medical study is actively looking for volunteers. It was posted on April 17th 2020 and later updated in March of 2022, according to clinicaltrials.gov."

Answered by AI

What is the current enrollment of participants for this experiment?

"Affirmative. Clinicaltrials.gov lists the study as currently recruiting, with the original posting date of April 17th 2020 and last update on March 9th 2022. For this trial, 800 people are being sought from a single location."

Answered by AI

What viral illnesses does Remdesivir typically combat?

"Remdesivir, a widely used antiviral medication, is often prescribed to hospitalized patients. This treatment can also be implemented for coronavirus disease 2019 (covid‑19), extracorporeal membrane oxygenation treatment and rheumatoid arthritis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

Lisa Barrett 2020. "Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04321993.

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