Trial ISRCTN59048638
Publication Gonzalez-Ochoa AJ , medRxiv, 2020 (preprint)
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: double blinding | |
| Location :
Single center / Mexico Follow-up duration (days): 21 | |
| 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 runny nose, difficulty breathing, 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. |
| Interventions | |
| Treatment
Sulodexide (500 LRU) Co-Intervention: Standard care Duration : 21 days |
|
| Control
Placebo Duration : 21 days | |
| Participants | |
| Randomized 312 participants (n1=157 / n2= 155) | |
| Characteristics of participants N=312 Mean age : 54.7 115 males Severity : Mild: n=243 / Moderate: n=0/ Severe: n=0 Critical: 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 death measured using patient records collected between baseline and 21 days. | |
| In the report The need for hospital admission and the total length of days (LOD) due to COVID-19 infection, need for oxygen support, and total days duration (including at home and hospital) | |
| Documents avalaible |
Protocol NR Statistical plan NR Data-sharing stated 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 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." |