Condition category
Infections and Infestations
Date applied
26/11/2020
Date assigned
27/11/2020
Last edited
21/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of April 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
To date, dexamethasone (a type of medicine called a steroid [corticosteroid]) has shown to decrease mortality (death rate) in patients who require oxygen, especially those with invasive mechanical ventilation. However, it is unknown if another corticosteroid can be used, and the optimal dose and duration to achieve a better clinical outcome. The aim of this study is to compare the differences in clinical outcome and laboratory results in hospitalized patients with severe SARS-CoV-2 pneumonia treated with dexamethasone versus patients treated with high-dose methylprednisolone.

Who can participate?
Adults aged over 18 with confirmed COVID-19 and suffering from pneumonia

What does the study involve?
Patients are treated with either dexamethasone or methylprednisolone according to the protocol set by the clinic. Recovery time is measured using patient records.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Clínica Medellín (Colombia)

When is the study starting and how long is it expected to run for?
April 2020 to November 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Miguel Pinzón
alejandropinzon01@yahoo.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Miguel Pinzón

ORCID ID

http://orcid.org/0000-0001-5840-9341

Contact details

Cra 65 B #30-95
Medellín
050020
Colombia
+57 (0)73127480251
alejandropinzon01@yahoo.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

20-33686

Study information

Scientific title

Dexamethasone vs methylprednisolone high dose for COVID-19 pneumonia

Acronym

Study hypothesis

To date, dexamethasone has shown a decrease in mortality in patients who require oxygen, especially those with invasive mechanical ventilation. However, it is unknown if another corticosteroid can be used, the optimal dose and its duration, to achieve a better clinical outcome. The study's objective was to compare the differences in clinical outcome and laboratory results in hospitalized patients with severe SARS-CoV-2 Pneumonia treated with dexamethasone at 6 mg doses versus patients treated with high-dose methylprednisolone.

Ethics approval

Approved 20/04/2020, the Clinica Medellin ethics committee (A Sede Occidente: Carrera 65 B # 30 - 95, Colombia; +57 (0)4 4020990 - opt 1 ext 617; investigacionesiqs@clinicamedellin.com), ref: 04-2020

Study design

Single-centre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

COVID-19 (SARS-CoV-2 infection) related pneumonia

Intervention

From 11/06/2020, patients were treated with dexamethasone 6 mg QD for seven to 10 days if they required oxygen.

After 15/09/2020, the clinic's protocol was modified to use methylprednisolone 250 to 500 mg every day for 3 days with a subsequent change to oral prednisone 50 mg every day for 14 days.

The researchers will compare the differences in clinical outcome and laboratory results in hospitalized patients with severe SARS-CoV2 pneumonia treated with dexamethasone at 6 mg doses versus patients treated with high-dose methylprednisolone.

Intervention type

Drug

Phase

Not Applicable

Drug names

Dexamethasone, methylprednisolone

Primary outcome measure

Recovery time measured in days using patient records; recovery time determined as the time until hospital discharge when each of the following criteria were met: decrease in laboratory severity markers, improvement in symptoms, decrease in oxygen requirement until nasal cannula or supplementary oxygen removal, and at least two doses of the respective treatment have been received

Secondary outcome measures

Respiratory health measured using arterial blood gas results during the period of hospitalization

(Cytokine Release Syndrome (CRS) defined as ventilatory impairment plus two of the following: C-reactive protein (CRP) greater than 10 mg/dl, serum ferritin greater than 1000 ng/ml, D-dimer greater than 900 ng/ml)

Overall trial start date

01/04/2020

Overall trial end date

15/11/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Over 18 years of age
2. Hospitalized with COVID-19 pneumonia confirmed by positive Real-Time Reverse Transcription Polymerase Chain Reaction for SARS-CoV2 (RT-PCR SARS-CoV-2) by Berlin protocol
3. Radiological confirmation of pneumonia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

216

Total final enrolment

213

Participant exclusion criteria

1. Contraindications associated with corticosteroids
2. Dissent for medical management
3. Death in the first 24 hours
4. Patient in palliative care or with a life expectancy of fewer than 6 months
5. If the patient required admission to the ICU and did not receive at least two doses of the corticosteroid
6. If the patient receives at least two doses of methylprednisolone but did not continue with prednisone, they were not included, but their outcome continued to be monitored
7. Patients who also received less than 2 days of dexamethasone treatment were withdrawn from study follow-up

Recruitment start date

11/06/2020

Recruitment end date

31/10/2020

Locations

Countries of recruitment

Colombia

Trial participating centre

Clínica Medellín
Cra 65 B #30-95
Medellín
050020
Colombia

Sponsor information

Organisation

Clínica Medellín - Grupo Quirónsalud

Sponsor details

Cra 65 B #30-95
Medellín
050020
Colombia
+57 (0)744446152
secreoc4-2@clinicamedellin.com.co

Sponsor type

Hospital/treatment centre

Website

https://www.clinicamedellin.com/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Miguel Alejandro Pinzón (alejandropinzon01@yahoo.es) with prior authorization by the ethics and research committee of the Medellin clinic. All data can be reviewed except for patient identification.

Intention to publish date

30/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/12/2020: The target enrolment has been changed from 213 to 216. 02/12/2020: Uploaded protocol and statistical analysis plan (not peer reviewed). 27/11/2020: Trial's existence confirmed by the Clinica Medellin ethics committee.