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Trial - NCT05371925


Column Value
Trial registration number NCT05371925
Full text link
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05371925

First author
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Edgar F Payan Arechiga, MD

Contact
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

alex8as2@yahoo.com.mx

Registration date
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

2022-05-12

Recruitment status
Last imported at : July 28, 2022, 3 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

inclusion criteria: over 18 years old male or female patients with documented pcr sars-cov-2 positive test obtained during the course of the disease convalescent covid-19 patient (define as at least 10 days after the onset of symptoms, no fever for at least 24 hours without the use of antipyretics and improvement of respiratory symptoms according to the quick covid-19 severity index (qcsi). signature of informed consent. moderate or worst clinical severity presentations of covid-19. (according to the world health organization clinical progression scale) risk of health complication >50% according to the health risk calculator

Exclusion criteria
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

concomitant use of another anticoagulant. known pregnancy. known hypersensitivity to sulodexide the need for hospital care at screening renal insufficiency with crcl <30ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. blood platelet count < 30 000/µl other conditions that are judged to carry an increased risk of bleeding as judged by the investigator elimination criteria: a patient randomized in error (monitoring shows that in- or exclusion criteria have been violated) who never received the trial medication, will be excluded from all analyses the investigator must discontinue study treatment for a given patient at any time for the following reasons: • in case of intolerable serious adverse reactions/events, which are clinically relevant, suspected to be related to trial intervention, and affect the patient´s safety. this will be at the discretion of the investigator.

Number of arms
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Centro Medico del Noroeste

Inclusion age min
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Hungary;Mexico

Type of patients
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

200

primary outcome
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

thrombomodulin;thrombomodulin

Notes
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1245, "treatment_name": "Sulodexide", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]