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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04654416
Recruitment Status : Completed
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Miguel Alejandro Pinzón, Clínica Medellín - Grupo Quirónsalud

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

Condition or disease Intervention/treatment
Covid-19 Drug: Corticosteroid with or without 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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Groups and Cohorts
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Group/Cohort Intervention/treatment
Steroids
Dexamethasone 6mg intravenous OD for seven to ten days
 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.
 Drug: Corticosteroid with or without colchicine
We describe the clinical outcome of patients treated with corticosteroid and colchicine


Outcome Measures
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Primary Outcome Measures :
  1. Outcome [ Time Frame: March 20 to August 07, 2020 ]
    Dead or alive


Eligibility Criteria
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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
Study Population
Adults with Covid-19 pneumonia
Criteria

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:

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Colombia
Clínica Medellín - Grupo Quirónsalud
Medellín, Antioquia, Colombia, 050020
Sponsors and Collaborators
Clínica Medellín - Grupo Quirónsalud
More Information
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Publications:
Deftereos SG, Giannopoulos G, Vrachatis DA, Siasos GD, Giotaki SG, Gargalianos P, Metallidis S, Sianos G, Baltagiannis S, Panagopoulos P, Dolianitis K, Randou E, Syrigos K, Kotanidou A, Koulouris NG, Milionis H, Sipsas N, Gogos C, Tsoukalas G, Olympios CD, Tsagalou E, Migdalis I, Gerakari S, Angelidis C, Alexopoulos D, Davlouros P, Hahalis G, Kanonidis I, Katritsis D, Kolettis T, Manolis AS, Michalis L, Naka KK, Pyrgakis VN, Toutouzas KP, Triposkiadis F, Tsioufis K, Vavouranakis E, Martinèz-Dolz L, Reimers B, Stefanini GG, Cleman M, Goudevenos J, Tsiodras S, Tousoulis D, Iliodromitis E, Mehran R, Dangas G, Stefanadis C; GRECCO-19 investigators. Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e2013136. doi: 10.1001/jamanetworkopen.2020.13136.

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Miguel Alejandro Pinzón, Clínica Medellín - Grupo Quirónsalud:
Dexamethasone
Corticosteroid
Covid-19
 Pneumonia
Colchicine
Clinical outcome
Additional relevant MeSH terms:
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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