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 March 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.
The COVID 19 pandemic has caused a severe impact not only for its clinical manifestation, but also the modifications imposed in the daily routine. The rapid dissemination and novelty of pathophysiology has limited the capability of obtaining useful and truthful information. Recently, information has been being obtained on the impact of this disease on the blood vessels.
The aim of this study is to know whether the use of sulodexide has any effect on the clinical response of patients presenting COVID-19.
Who can participate?
Adults between 40 - 80 years old, with confirmed COVID-19.
What does the study involve?
Patients that visit emergency ward or primary care facility with clinical symptoms of COVID-19 will start oral dose of sulodexide.
A follow-up visit will be scheduled via electronic media (home phone, cell phone, computer, video-connect) at 7 day intervals for 21 days, if there is no form of electronic communication, a personal visit will be arranged at the participant home by one of the trial collaborators. Extra follow-up session will be available at a 24hrs phone line for emergencies as needed.
If hospital care is needed, a follow-up visit will be arranged every day during the course of the hospital stay by a trial collaborator, not interfering with hospital policies or treatments established. If the treating physician determines the necessity to terminate sulodexide, the practitioners will stop medication.
What are the possible benefits and risks of participating?
Benefits: when infected with COVID-19 the use of sulodexide may reduce the severity of clinical symptoms avoiding the need for hospital admission and/or develop more severe complications.
Risks: only the ones related to the use of the medication, mostly reported gastrointestinal discomfort in some patients. will not interfere with commonly recommend treatment of COVID-19
Where is the study run from?
CLINEDEM (Mexico)
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 Alejandro Jose Gonzalez Ochoa, alex8as2@yahoo.com.mx
Trial website
Contact information
Type
Scientific
Primary contact
Dr Alejandro Jose Gonzalez Ochoa
ORCID ID
http://orcid.org/0000-0001-5068-623X
Contact details
Cjon 5 De Mayo y Calle 7
No 791 Int 1b
San Luis Rio Colorado
83449
Mexico
+52 6535367497
ALEX8AS2@YAHOO.COM.MX
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Sulodexide in the treatment of early stages of COVID-19
Acronym
ERSul study
Study hypothesis
Use of a medication with endothelium restoration, antiinflammatory and antithrombotic properties can reduce the severity of presentation of in COVID-19 positive patients
Ethics approval
Approved 28/05/2020 Comite de Etica e Investigacion Facultad de Medicina Mexicali (Coordinacion de posgrado e Investigacion, Av Alvaro Obregon y Julian Carrillo s-n Col. Nueva CP 21100; +52 686 551 9497; cei.fm@uabc.edu.mx), ref: none provided
Study design
Prospective interventional cohort study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
COVID-19 (SARS-CoV-2 infection)
Intervention
Current interventions as of 09/09/2020:
Group A: patients with COVID-19 early symptoms to received mask placebo 500LRU twice a day +
standard of care.
Group B: patients with COVID-19 early symptoms to received Sulodexide 500 RLU bid + standard
of care
Group A and B will be randomized by computer software allocation program.
For group A participants, general demographic information will be collected and baseline serum levels of d-dimer, C-reactive protein, Creatinine will be taken; a collaborating physician will be followed to the study under physical home or virtual visit (cell, computer, telephone) every 7 days for a period of 21 days as available, making records of any symptomatology referred to by the patient or need to go to the hospital; in case of admission to hospital, information is requested from your treating physician about its evolution until its release, prior authorization by the patient.
Previous interventions:
Group A: patients with COVID-19 early symptoms to received placebo + conventional treatment;
Group B: patients with COVID-19 early symptoms to received Sulodexide 250 RLU bid + conventional treatment
Group C: high risk of infection to received sulodexide 250 RLU
Group A and B will be randomized by computer software allocation program, group C will be not randomized. Treatment will last 1 month.
For group A participants, general demographic information will be collected and baseline levels of D-dimer taken; will receive placebo on the same packaging as your original sulodexide, a collaborating physician will be followed to the study under physical home or virtual visit (cell, computer, telephone) every 7 days for a period of 21 days as available, making records of any symptomatology referred to by the patient or need to go to the hospital; in case of admission to hospital, information is requested from your treating physician about its evolution until its release, prior authorization by the patient.
If the patient is assigned group B, he will receive doses of sulodexide taking 250LRU (1 tablet) every 12 hours, basal levels of D-dimmer will be taken, will receive the same follow-up as group A.
If group C is assigned, the participant will receive an oral dose of 250LRU every 12 hours for 21 days, if it remains asymptomatic COVID-19 test at 21 days, if you report negative, the participation in the study will be terminated; in case of initiating suspicious symptomatology, testing for COVID-19 will be performed, if positive, will follow the same protocol of group B in relation to follow-up, if negative, will be terminated its participation in the study.
Intervention type
Drug
Phase
Not Applicable
Drug names
Sulodexide
Primary outcome measure
Current primary outcome measure as of 09/09/2020:
The Clinical-Therapeutic response will be defined as the need for hospitalization, length of stay in hospital (days), need for oxygen support, length of need for oxygen support (days), and death measured using patient records collected between baseline and 21 days
Previous primary outcome measure:
The Clinical-Therapeutic response will be defined as the need for hospitalization, presence of thromboembolic complications, length of stay in hospital (days), need for use of mechanical ventilation, need for hemodialysis, major haemorrhagic complications, death measured using patient records throughout the study
Secondary outcome measures
Current secondary outcome measures as of 09/09/2020:
1. Serum levels of D dimer, C-reactive protein, and Creatinine measured by a blood test at baseline and 14 days
2. Incidence of a thromboembolic event confirmed by ultrasound or CT between baseline and 21 days
3. Incidence of a major bleeding event between baseline and 21 days
Previous secondary outcome measures:
Levels of D dimmer measured by a blood test in an authorized laboratory site. in group A and B, will be measured at the first visit and at the end of the trial (21 days). Group C will be measured only if positive COVID-19 infection
Overall trial start date
15/04/2020
Overall trial end date
30/11/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current participant inclusion criteria as of 09/09/2020:
1. Less than 3 days onset of COVID-19 suspected symptoms
2. Age between 40 - 80 years
3. Body mass index between 18 - 35 kg/m²
4. >50% calculated risk for severe clinical progression
Previous participant inclusion criteria:
1. Less than 3 days onset of COVID-19 suspected symptoms
2. Age between 40 - 80 years
3. Body mass index between 18 - 35 kg/m²
4. History of DM, hypertension, CPOD, or other chronic disease
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
Current participant exclusion criteria as of 09/09/2020:
1. COVID-19 negative test.
2. Reluctant to take medication
3. Reluctant to followup
4. Bed confinement
5. Chronic use of steroids
6. History of deep vein thrombosis in the last 6 months
7. Chronic use of anticoagulation
8. Already in hospital care
9. Previous treatment for COVID-19
Previous participant exclusion criteria:
1. COVID-19 negative test.
2. Reluctant to take medication
3. Reluctant to followup
4. Bed confinement
5. Chronic use of steroids
6. History of deep vein thrombosis in the last 6 months
7. Chronic use of anticoagulation
Recruitment start date
15/06/2020
Recruitment end date
06/08/2020
Locations
Countries of recruitment
Mexico
Trial participating centre
CLINEDEM
Cjon 5 De Mayo y Calle 7 No 791 Int 1b
San Luis Rio Colorado
83449
Mexico
Sponsor information
Organisation
CLINEDEM
Sponsor details
Cjon 5 De Mayo Calle 7 #791
San Luis Rio Colorado
83449
Mexico
+52 6535367497
2alex8as@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
alfasigma Mexico
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Journal publication, oral meeting presentation.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
12/12/2020
Participant level data
Other
Basic results (scientific)
Publication list