Corticosteroids for COVID-19

Overseen By Rebecca Schoenecker

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Minnesota

Must not be taking: Chronic corticosteroids

Disqualifiers: SARS-CoV-2, Tuberculosis, Herpes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of corticosteroids, a medication that reduces inflammation, for adults hospitalized with severe respiratory infections and low oxygen levels. Participants will receive either a corticosteroid treatment or no additional treatment to determine if the medication improves their condition. The trial seeks individuals hospitalized with severe breathing problems and low oxygen levels, excluding those with known COVID-19 or conditions that corticosteroids could worsen. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on high doses of corticosteroids, you may not be eligible to participate.

What is the safety track record for this treatment?

Research has shown that corticosteroids can help people with COVID-19 by reducing the risk of death and slowing disease progression. Studies have examined both high and low doses of these drugs. Although results vary, they generally appear safe for short-term use.

One study found that corticosteroids reduced the need for intensive care and breathing machines, indicating that patients usually tolerate them well. However, the optimal treatment duration appears to be about six days, which this trial is testing.

These findings suggest that corticosteroids are generally safe for people with severe COVID-19. However, every treatment carries risks, so it is important to consider both the benefits and possible side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using corticosteroids for COVID-19 because they may offer rapid relief by reducing inflammation in severely ill patients. Unlike typical antiviral treatments that target the virus itself, corticosteroids work by calming the immune system's aggressive response, which can be more harmful than the virus in severe cases. This approach could potentially lead to quicker recovery times and shorter hospital stays for patients.

What is the effectiveness track record for corticosteroids in treating severe acute respiratory infections?

Research has shown that corticosteroids can reduce the risk of death in patients with severe COVID-19. Studies have found that these medications can lower the death rate by about 20% in such cases. In this trial, participants in the corticosteroid group will receive systemic corticosteroids, the first drugs identified to decrease the risk of death in critically ill COVID-19 patients. Experts agree that these medications effectively manage severe breathing problems, including those caused by COVID-19. Research from China and other countries supports this view. ^{2 4 6 7 8}

Who Is on the Research Team?

Cavan Reilly, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

The STAR Trial is for adults hospitalized with severe acute respiratory infections and low oxygen levels, likely due to COVID-19. Participants must not have other health conditions that could interfere with the study or be on treatments that affect immune response.

Inclusion Criteria

Hypoxemia meeting specific criteria at the time of eligibility assessment

I am 18 years old or older.

I was hospitalized with a severe respiratory infection within the last 10 days.

Exclusion Criteria

Prisoner

Investigator deems trial participation not in patient's best interest

Patient or surrogate declines to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive systemic corticosteroids at a dose equivalent to 40 mg of prednisolone per day for 7 days or until discharge

7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroid

Trial Overview This trial tests if a steroid treatment (equivalent to 40 mg of prednisolone per day) for 7 days can help patients compared to no steroid use. It's conducted across multiple centers where patients are randomly assigned to one of the two groups.

How Is the Trial Designed?

Group I: Corticosteroid Group Experimental Treatment 1 Intervention

Participants in the corticosteroid group will receive systemic corticosteroids at a dose equivalent to 40 mg of prednisolone per day for 7 days or until discharge, whichever is sooner. Clinicians will select the systemic corticosteroid medication and the route of administration.

Group II: Control Group Active Control 1 Intervention

Participants in the no corticosteroid group will not receive systemic corticosteroids for 7 days or until hospital discharge, whichever is sooner, unless (i) they meet prespecified criteria for the administration of systemic corticosteroids (e.g., anaphylaxis) or (ii) their clinicians determine that the administration of systemic corticosteroids is required for the optimal care of the participant for other reasons.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9752099/

Effectiveness of corticosteroids to treat coronavirus disease ... Our results showed that corticosteroid therapy was related to a reduction in all-cause mortality in severe COVID-19 patients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2213398424003646

Efficacy of corticosteroids in COVID-19: An evidence-based ... Historically, corticosteroids have shown efficacy in treating other severe respiratory conditions, such as Middle East Respiratory Syndrome (MERS),7 Acute ...

3. virologyj.biomedcentral.com virologyj.biomedcentral.com/articles/10.1186/s12985-024-02345-7

Efficacy of different doses of corticosteroids in treating severe ... Systemic corticosteroids are considered effective in treating severe or critical COVID-19 patients in both Chinese and international consensus ...

4. nature.com nature.com/articles/s41598-024-75926-9

Corticosteroids for hospitalized patients with severe/critical ... Corticosteroids were identified as the first drug able to reduce mortality in severe or critically ill patients with COVID-19.

5. who.int who.int/news-room/questions-and-answers/item/coronavirus-disease-covid-19-dexamethasone

Coronavirus disease (COVID-19): Corticosteroids, ... Data from these studies show that deaths are reduced by 20% when patients with severe COVID-19 are given corticosteroid treatment during their ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7735177/

Corticosteroid use in COVID-19 patients: a systematic ... Our findings from both observational studies and RCTs confirm a beneficial effect of corticosteroids on short-term mortality and a reduction in need for ...

7. thennt.com thennt.com/nnt/systemic-corticosteroids-covid-19/

Systemic Corticosteroids for COVID-19 It was the first trial to suggest that systemic corticosteroids, such as dexamethasone, may decrease the risk of death and decrease the progression of disease ...

8. academic.oup.com academic.oup.com/ofid/article/10/3/ofad105/7055978

Optimal Duration of Systemic Corticosteroids in Coronavirus ... In this meta-analysis, optimal duration of corticosteroids for hospitalized COVID-19 patients was up to 6 days, with no additional survival benefit with &g.