Clinical Outcome of Patients With COVID-19 Pneumonia Treated With Corticosteroids and Colchicine

Study Overview
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Brief Summary
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Cross sectional study of 301 adult patients with Covid-19 Pneumonia treated with corticosteroid and/or colchicine

Detailed Description
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A cross sectional study of 301 adult patients with Covid-19 Pneumonia confirmed by Real-Time Polymerase Chain Reaction for SARS-CoV2 (RT-PCR SARS-CoV2), Berlin protocol, who required hospitalization in three hospitals in Antioquia, Colombia. Patients were treated according to the institutional protocol (from March 20, 2020 to June 30, 2020) with corticosteroid if the patient required supplemental oxygen. From July 1, 2020, the management protocol changed with the addition of colchicine to all patients admitted to the institutions. The treatment was supervised and monitored by the same specialist in infectology of the institutions. We describe the clinical manifestations and outcomes of the patients who received these treatments. The patient's information was analyzed according to the outcome of interest (alive/dead) with univariate, bivariate, and multivariate measures to adjust the variables that presented statistical association.

Official Title
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Clinical Outcome of Patients With COVID-19 Pneumonia Treated With Corticosteroids and Colchicine in Colombia

Conditions
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Covid-19

Intervention / Treatment
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* Drug: Corticosteroid with or without colchicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The included patients were older than 18 years hospitalized for Covid-19 Pneumonia, confirmed positive by Real-Time Reverse Transcription Polymerase Chain Reaction for SARS-CoV2 (RT-PCR SARS-Cov2) by Berlin protocol. The samples were taken from a nasopharyngeal swab. The patients should also have radiological confirmation of Pneumonia, mostly chest tomography or chest X-rays, to support the diagnosis of Covid-19 Pneumonia. Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Steroids<br>Dexamethasone 6mg intravenous OD for seven to ten days | Drug: Corticosteroid with or without colchicine<br>* We describe the clinical outcome of patients treated with corticosteroid and colchicine<br>|
| Colchicine<br>Patients treated with colchicine at a dose of 0.5 mg every 12 hours for 7 to 14 days. | Drug: Corticosteroid with or without colchicine<br>* We describe the clinical outcome of patients treated with corticosteroid and colchicine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome | Dead or alive | March 20 to August 07, 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexamethasone, Corticosteroid, Covid-19, Pneumonia, Colchicine, Clinical outcome