Status:
WITHDRAWN
Corticosteroids for COVID-19
Lead Sponsor:
University of Alberta
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 incre...
Detailed Description
The proposed trial is an interventional, randomized, placebo-controlled, adaptive clinical trial in outpatients with symptomatic microbiologically-confirmed SARS-CoV-2, in stable clinical condition, a...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Microbiologically-confirmed SARS-CoV-2.
- Clinical symptoms compatible with COVID-19 for 14 days or less before randomization.
- Oxygen saturation ≥ 95%.
- Protein C-reactive in blood performed by point-of-care testing ≥ 20 mg/L.
- Signed informed consent.
Exclusion
- Oxygen requirement at home due to chronic lung disease.
- 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.
- Chronic liver damage Child-Pugh C.
- Chronic underlying process with suspected life expectancy less than 12 weeks.
- 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.
- Diagnosis of any form of psychosis without receiving appropriate treatment.
- Pregnancy at time of randomization.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04795583
Start Date
August 1 2021
End Date
August 1 2022
Last Update
April 14 2022
Active Locations (2)
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1
Clinica de la Mujer
Bogotá, Colombia
2
ABC Medical Center
Mexico City, Mexico