Sulodexide vs Placebo (RCT)

Mild outpatients

FOREST PLOTS -2021-05-27

Studies description

Trial ISRCTN59048638
Publication ERSul - Gonzalez-Ochoa AJ , Thromb Haemost (2021) (published paper)
Dates: 2020-06-05 to 2020-08-05
Funding: Private (Study independently initiated by lead researcher; partially funded by Alfasigma Mexico.)
Conflict of interest: Yes

Methods
RCT
Blinding: Participants and outcome assessor
Location : Single center / Mexico
Follow-up duration (days): 26
Inclusion criteria
  • male or female
  • age over 40 years
  • body mass index of 18-35 kg/m2
  • with suspected COVID-19 clinical symptoms within 3 days of onset or less defined as any two of cough, fever, headache plus one of sniff, dyspnea, diarrhoea, loss of smell/taste, conjunctivitis, body/muscle ache
  • high risk (>50%) of a severe clinical disease progression according to the percentage of risk given by the COVID-19 Health Complication (C19HC) calculator (IMSS, Gobierno de Mexico), which considers different chronic comorbidities.
Exclusion criteria
  • a negative COVID-19 PCR test
  • already in hospital care or severe clinical symptoms that warrant immediate hospital care
  • prolonged anticoagulation
  • venous thromboembolism in the past six months
  • known pregnancy
  • chronic use of steroid medication in the last six months
  • bed confinement in the last six months
  • previous treatment for COVID-19
  • Reluctant to take medication
  • Reluctant to followup
  • chronic use of steroid medication in the previous six months.
Interventions
Treatment
Sulodexide
500 LRU orally twice daily for two weeks.
Control
Placebo

Participants
Randomized
participants :
Sulodexide=157
Placebo=155
Characteristics of participants
N= 312
Mean age : NR
115 males
Severity : Mild: n= 243/ Asymptomatic: n=0
Primary outcome
In the register
Current primary outcome measure as of 09/09/2020 (revised): 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
In the report
The primary endpoint was the need for hospital admission for clinical care.
Documents
avalaible

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published/pre-print article, the study registry was used in data extraction and assessment of risk of bias. There were no substantive differences in study procedures, population and interventions between the pre-print article and the registry. Mortality was specified as a primary outcome in the registry but reported as a secondary outcome in the report. The exclusion criteria, and other the primary and secondary outcomes were modified in the registry during the trial, with no details on why this was done. The study achieved its pre-stated sample size. 22% missing data due to COVID-19 negative test result and lost to follow-up; this was similar between groups. Data were analyzed using per-protocol analysis.
Quote: "Although initially an intention-to-treat analysis had been proposed, the inclusion of only confirmed COVID-19 patients and the exclusion of patients who had initiated the treatment but later reported a negative COVID-19 result led to us analysing variables according to a per-protocol principle."
The study was updated on March 23rd, 2021, based on a published abstract in the Journal of Vascular Surgery
On 29th of March,2021, this study was updated based on the published report in Thromb Haemost.