Clinical trial NCT04420299: Clinical Trial on the Efficacy and Safety of Bemiparin in Patients Hospitalized Because of COVID-19
Official title: A Randomized, Single-blind Study With a Parallel Control Group on the Efficacy and Safety of Bemiparin at Therapeutic Dose vs. Prophylactic Dose in Patients Hospitalized for COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid-19
Keywords: covid-19
immunothrombosis
d-dimer
Lead sponsor: Fundación de investigación HM
Sponsor class: OTHER
Collaborators: name: Syntax for Science, S.L
First posted: 2020-06-09
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, single-blind, parallel control group
Primary purpose: TREATMENT

Brief summary: The 2019 coronavirus disease (Covid-19) is a new disease caused by the SARS-CoV2 virus of which many things are not yet known. Among others, there is a need to define the best therapeutic strategy to treat Covid-19, improving patients survival and reducing complications in its management, for which many different types of treatments are being tested.

The drug being tested in this clinical trial is called bemiparin. Bemiparin is a drug authorized as a prevention and as a treatment for deep vein thrombosis (blood clots in one or more veins, generally in the legs) and venous thromboembolism (when the clot can detach and lodge in other organs such as the lungs). Covid-19 patients have been shown to be at increased risk of developing clotting problems such as those described above.

In this context, this clinical trial is being carried out to find out if certain doses of bemiparin can contribute to better management of the disease.


Eligibility criteria: Inclusion Criteria:

1. Informed consent.
2. Age of 18 years or more.
3. Patient with suspected COVID-19 and who meets hospitalization criteria.
4. D-dimer\> 500 ng / ml.
5. Clinical characteristics highly compatible with SARS-CoV-2 infection and confirmation by RT-qPCR at baseline or in the second sample in case of a first negative test and clinical suspicion remains.
6. Patient admitted to hospital

Exclusion Criteria:

1. ICU admission criteria.
2. Need for invasive or not invasive mechanical ventilation
3. Pregnancy.
4. Creatine clearance \<30 ml / min (Cockroft-Gault).
5. Severe liver or pancreatic function disorder.
6. Acute bacterial endocarditis and slow endocarditis.
7. Patient previously anticoagulated (although it is allowed to have received heparin at a previous low dose without time limit).
8. Patient with high hemorrhagic risk due to previous medical-surgical history.
9. Severe thrombocytopenia (\<80,000 platelets/ mm3) or known history of heparin-induced thrombocytopenia.
10. Active bleeding or increased risk of bleeding from haemostasis disorders or from organic lesions that are liable to bleed (eg, active peptic ulcer, hemorrhagic stroke, aneurysms, or brain malignancies).
11. Damage or surgical interventions in the central nervous system, eyes and ears that have taken place in the last 2 months.
12. Simultaneous participation in another clinical trial that could have a conflictive interaction with what it is intended to evaluate.
13. Any situation that in the opinion of the researcher could interfere with the treatment or with the evolution of the patient.

Primary outcomes:
measure: Proportion of patients that worsen
timeFrame: Day 10 +/- 1
Secondary outcomes:
measure: Mortality from any cause at day 28
timeFrame: Day 28
measure: Proportion of subjects that requires admission to the ICU
timeFrame: From study start to day 28
measure: Proportion of subjects requiring non-invasive mechanical ventilation
timeFrame: From study start to day 28
measure: Proportion of subjects requiring invasive mechanical ventilation.
timeFrame: From study start to day 28
measure: Proportion of subjects with some organ failure
timeFrame: From study start to day 28
measure: Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline
timeFrame: From study start to day 28
measure: Proportion of subjects with pathological angioTAC
timeFrame: At day 10 +/-1
measure: Proportion of subjects with improvement in chest radiography
timeFrame: At day 10 +/-1
measure: Proportion and median hospital discharge between patients in both groups.
timeFrame: From study start to day 28
measure: Titration score
timeFrame: From study start to day 28
measure: Ferritin score
timeFrame: From study start to day 28
measure: D-dimer modification score
timeFrame: From study start to day 28
measure: Adverse events (total and serious).
timeFrame: From study start to day 28
measure: Related adverse events (total and serious).
timeFrame: From study start to day 28
measure: Clinically relevant major and non major hemorrhages.
timeFrame: From study start to day 28
Other outcomes:
Locations:
city: Boadilla Del Monte
country: Spain
facility: Hospital Universitario HM Montepríncipe
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario HM Puerta del Sur
state: Madrid
Study officials:
affiliation: Director
name: Antonio Cubillo, MD
role: STUDY_DIRECTOR
References:
citation: Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.