Corticosteroids for COVID-19

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is an interventional, randomized, placebo-controlled, adaptive clinical trial in outpatients with symptomatic microbiologically-confirmed SARS-CoV-2, in stable clinical condition, and increased levels of serum C-reactive protein. The hypothesis of this study is that early administration of prednisone for 7 days in patients with evidence of increased C-reactive protein will decrease the progression of COVID-19, prevent clinical deterioration, and hospital admission. Objectives: Primary Objective: To evaluate if early administration of corticosteroids in non-hospitalized participants with proven SARS-CoV-2 infection with compatible clinical symptoms and increased C-reactive protein can prevent hospital admission or early death

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Treatments: Prednisone

Criteria

Inclusion Criteria:

1. Age ≥ 18 years.

2. Microbiologically-confirmed SARS-CoV-2.

3. Clinical symptoms compatible with COVID-19 for 14 days or less before randomization.

4. Oxygen saturation ≥ 95%.

5. Protein C-reactive in blood performed by point-of-care testing ≥ 20 mg/L.

6. Signed informed consent.

Exclusion Criteria:

1. Oxygen requirement at home due to chronic lung disease.

2. Patients with immunosuppression or immunosuppressive therapies defined as:

• Cancer on active chemotherapy.

• Stem cell transplant in the previous 6 months.

• Neutrophil count < 1000 cells/mm3.

• Chronic treatment with immunosuppressive therapy, except for low-dose (≤10 mg daily) prednisone or equivalent dose of other corticosteroids.

• HIV-infected patients with CD4 < 200 x 106/L.

• Diagnosis with primary immunodeficiencies.

3. Chronic liver damage Child-Pugh C.

4. Chronic underlying process with suspected life expectancy less than 12 weeks.

5. Uncontrolled diabetes mellitus at screening, defined as no blood glucose testing or any blood glucose level higher than 14 mmol/L (or 250 mg/dL) in the last 14 days.

6. Diagnosis of any form of psychosis without receiving appropriate treatment.

7. Pregnancy at time of randomization.