Sulodexide (VESSEL DUE-F) in the

Treatment of Patients with Early Stages

of COVID-19: a randomized controlled
trial
AUTHORS:
Alejandro J. Gonzalez-Ochoa MD, Joseph D. Raffetto MD ; Ana G. Hernández MD , Nestor Zavala MD , Obed Gutiérrez MD, Arturo
Vargas, MD, Jorge Loustaunau MD
CLINEDEM callejón 5 de mayo y calle 7 No 791, Colonia Comercial, 83449 San Luis Rio Colorado, Sonora México

Published online 2021 Feb 15. doi: 10.1016/j.jvsv.2020.12.012

Thromb Haemost DOI: 10.1055/a-1414-5216

Sulodexide Trial on Early Stage of COVID-19
Population 243 patients with early clinical stage of COVID-19

Intervention SDX group – 2 caps of 250 LSU BID for 21 days

Placebo group – 2 caps BID for 21 days

Methodology Prospective, randomized, placebo-controlled with

parallel group design

Outcome Primary endpoint: need for hospitalization

Secondary endpoint: need for oxygen support and
reduction in D-dimer and CRP levels

Results  Reduction in hospitalization rate by 40%

 Reduction in supplemental oxygen support
 Reduction in D-dimer and C-reactive protein levels
 Numerically lower in numbers of death
 Sulodexide-COVID-19 trial criteria
Inclusion criteria
• Age > 40 years Male or female Body
Mass index of 18 - 35 kg/m2
• The onset of 3 days or less of
suspected COVID-19 symptoms
defined as any two of cough, fever, or
headache. Plus one of sniff, dyspnea,
diarrhea, loss of smell/taste,
conjunctivitis, or body/muscle ache
• Signed informed consent
• †High level risk to develop a severe
clinical progression of COVID-19.
Exclusion criteria
• A negative RT-PCR SARS-CoV- 2 test
result
• Known pregnancy
• *Prolonged anticoagulation in the last
six months
• History of deep vein thrombosis in the
previous six months
• Severe clinical symptoms that warrant
immediate hospital care
• Chronic use of steroid medication in
the previous six months
• Bed confinement in the last six
months
• Already hospitalized for other
reasons.
• Previous treatment for COVID-19
Thromb Haemost DOI: 10.1055/a-1414-5216
 Study Design

Research site

Hospital care
Patient at home
Suspended Sulodexide

Emergency department evaluation

(blinded group allocation)

Primary physician standard of care

(blinded group allocation)
 Figure 1.- CONSORT flow diagram.

COVID-19 suspected
symptomatic patients
Asses of eligibility Excluded n= 344
n=656
Not completed survey n=46
Not meet inclusion criteria n=133
Meet exclusion criteria n=120
Decline to participate n= 31
Fail of timely disperse medication to
start treatment (logistic limitations due
to pandemic region lockdown) = 14
Randomized to allocation
n=312

Study group Control Group

Sulodexide oral 500 LRU twice a day Placebo oral twice a day
n= 157 n= 155

Excluded from analysis n= 33 Excluded from analysis n= 36

COVID-19 negative test n= 14 COVID-19 negative test n = 17

Lost to follow-up data n=8
Lost to follow-up n=12
Voluntary abandoned trial n= 7 Voluntary abandoned trial n= 11

Analyzed n= 124 Analyzed n=119

Results

Thromb Haemost DOI: 10.1055/a-1414-5216

Outcome:
Clinical Symptoms
Conclusion
• The use of Sulodexide (VESSEL DUE-F) in early COVID reduced the need for
hospital care and supplemental oxygen
• Sulodexide reduced the levels of D-dimer and CRP
• No effect on total days of hospital care
• Mortality was underpowered to show difference
• Limitations due to Pandemic regional lockdown
• Results are promising and justify larger multicenter trials