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Corticosteroids for COVID-19

NCT04795583 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-04-14

No results posted yet for this study

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

Interventions

DRUG

Prednisone

Prednisone 25 mg capsules

DEVICE

Point of Care testing device for C-reactive protein

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

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-04-30
Completion
2022-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • Colombia
  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04795583 on ClinicalTrials.gov