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

Completed

• Conditions: Covid-19
• Interventions: Drug: Corticosteroid with or without colchicine

• Registration Number: NCT04654416
• Lead Sponsor: Clínica Medellín - Grupo Quirónsalud

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-03-20
• Primary Completion: 2020-08-07
• Study Completion: 2020-08-20
• Status Verified: 2020-12
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Last Update Submitted: 2020-12-02
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colchicine	Corticosteroid with or without colchicine	Patients treated with colchicine at a dose of 0.5 mg every 12 hours for 7 to 14 days.
Steroids	Corticosteroid with or without colchicine	Dexamethasone 6mg intravenous OD for seven to ten days

Primary Outcome Measures

Name	Time	Method
Outcome	March 20 to August 07, 2020	Dead or alive

Trial Locations

Locations (1)

Clínica Medellín - Grupo Quirónsalud; 🇨🇴 Medellín, Antioquia, Colombia