Clinical Outcome of Patients With COVID-19 Pneumonia Treated With Corticosteroids and Colchicine
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ClinicalTrials.gov Identifier: NCT04654416 |
Recruitment Status :
Completed
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
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Condition or disease | Intervention/treatment |
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Covid-19 | Drug: Corticosteroid with or without colchicine |
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 Type : | Observational |
Actual Enrollment : | 301 participants |
Observational Model: | Case-Crossover |
Time Perspective: | Cross-Sectional |
Official Title: | Clinical Outcome of Patients With COVID-19 Pneumonia Treated With Corticosteroids and Colchicine in Colombia |
Actual Study Start Date : | March 20, 2020 |
Actual Primary Completion Date : | August 7, 2020 |
Actual Study Completion Date : | August 20, 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Steroids
Dexamethasone 6mg intravenous OD for seven to ten days
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Drug: Corticosteroid with or without colchicine
We describe the clinical outcome of patients treated with corticosteroid and colchicine |
Colchicine
Patients treated with colchicine at a dose of 0.5 mg every 12 hours for 7 to 14 days.
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Drug: Corticosteroid with or without colchicine
We describe the clinical outcome of patients treated with corticosteroid and colchicine |
- Outcome [ Time Frame: March 20 to August 07, 2020 ]Dead or alive

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04654416
Colombia | |
Clínica Medellín - Grupo Quirónsalud | |
Medellín, Antioquia, Colombia, 050020 |
Responsible Party: | Miguel Alejandro Pinzón, Internal Medicine - Infectious Diseases Specialist, Clínica Medellín - Grupo Quirónsalud |
ClinicalTrials.gov Identifier: | NCT04654416 |
Other Study ID Numbers: |
04-2020 |
First Posted: | December 4, 2020 Key Record Dates |
Last Update Posted: | December 4, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dexamethasone Corticosteroid Covid-19 |
Pneumonia Colchicine Clinical outcome |
COVID-19 Colchicine Pneumonia Respiratory Tract Infections Infections Pneumonia, Viral Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |