Corticosteroids for COVID-19

NCT04795583 | Withdrawn Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: 00001
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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 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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Hospital admission or death in the first 2 weeks after randomization

  Need to be admitted to hospital or death during the first 2 weeks after randomization

  14 days

Secondary Outcomes (5)

• Hospitalization at 30 days

  30 days

• Mortality at 30 days

  30 days

• Serious adverse events at 30 days

  30 days

• Death at week 12

  Week 12

• Duration of symptoms

  Week 12

Other Outcomes (1)

• Long COVID-19

  12 weeks

Study Arms (2)

Prednisone

EXPERIMENTAL

Treatment adjusted by weight. Prednisone 25 mg capsules: * ≤ 50kg = 2 capsules QD x 7 days (maximum dose = 50mg/day) * 50 - 80kg = 3 capsules QD x 7 days (maximum dose = 75mg/day) * \> 80kg = 4 capsules QD x 7 days (maximum dose = 100mg/day)

Drug: Prednisone; Device: Point of Care testing device for C-reactive protein

Placebo

PLACEBO COMPARATOR

Capsules with the same appearance as Prednisone

Device: Point of Care testing device for C-reactive protein

Interventions

Prednisone DRUG

Prednisone 25 mg capsules

Prednisone

Point of Care testing device for C-reactive protein DEVICE

Determination of C-reactive protein blood levels by point of care testing device

Placebo; Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

Clinica de la Mujer

Bogotá, Colombia

Location

ABC Medical Center

Mexico City, Mexico

Location

MeSH Terms

Conditions

COVID-19

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 12, 2021
• Study Start: August 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: August 1, 2022
• Last Updated: April 14, 2022

Record last verified: 2021-06

Locations

CO (1); ME (1)