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Covid-19Phase 2NCT04420299

Clinical Trial on the Efficacy and Safety of Bemiparin in Patients Hospitalized Because of COVID-19

A Phase 2 study testing Bemiparin in people with Covid-19, run by Fundación de investigación HM at 2 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid-19
What is being tested?
Bemiparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
2 sitesSpain
Study dates
4 Jun 2020to 8 Jun 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent.
  • Age of 18 years or more.
  • Patient with suspected COVID-19 and who meets hospitalization criteria.
  • D-dimer> 500 ng / ml.
  • 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.
  • Patient admitted to hospital

Who cannot join

  • ICU admission criteria.
  • Need for invasive or not invasive mechanical ventilation
  • Pregnancy.
  • Creatine clearance <30 ml / min (Cockroft-Gault).
  • Severe liver or pancreatic function disorder.
  • Acute bacterial endocarditis and slow endocarditis.
Show all 13Show fewer
  • Patient previously anticoagulated (although it is allowed to have received heparin at a previous low dose without time limit).
  • Patient with high hemorrhagic risk due to previous medical-surgical history.
  • Severe thrombocytopenia (<80,000 platelets/ mm3) or known history of heparin-induced thrombocytopenia.
  • 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).
  • Damage or surgical interventions in the central nervous system, eyes and ears that have taken place in the last 2 months.
  • Simultaneous participation in another clinical trial that could have a conflictive interaction with what it is intended to evaluate.
  • Any situation that in the opinion of the researcher could interfere with the treatment or with the evolution of the patient.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Universitario HM Montepríncipe

    Boadilla del Monte, Madrid, 28660

  • Hospital Universitario HM Puerta del Sur

    Móstoles, Madrid, 28938

Other trials in Spain

About this study

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

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.

Conditions
Covid-19
Being tested
Bemiparin
Keywords
covid-19, immunothrombosis, d-dimer
Medical subject headings
COVID-19, Thromboinflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BemiparinDrug

    Also called Therapeutic dose

    Bemiparin at therapeutic dose for 10 days

  • BemiparinDrug

    Also called Prophylactic dose

    Bemiparin at prophylactic dose for 10 days

Study groups in NCT04420299
Study groupRoleWhat they receive
Experimental - therapeutic bemiparin doseExperimentalSub-cutaneous dose of bemiparin at therapeutic dose for 10 days
Receives: Drug: Bemiparin
Control - prophylactic bemiparin doseExperimentalSub-cutaneous dose of bemiparin at prophilactic dose for 10 days
Receives: Drug: Bemiparin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients that worsen

    Combined worsening variable. Presence of any of the following will be considered worseing:

    1. Death.
    2. ICU admission.
    3. Need for either non-invasive or invasive mechanical ventilation.
    4. Progression to moderate / severe respiratory distress syndrome according to objective criteria (Berlin definition).
    5. Venous thromboembolism (deep vein thrombosis or pulmonary embolism) or arterial (acute myocardial infarction or stroke).

    Measured: Day 10 +/- 1

Secondary outcomes (15)

  1. Mortality from any cause at day 28

    Mortality from any cause

    Measured: Day 28

  2. Proportion of subjects that requires admission to the ICU

    Proportion of subjects that requires admission to the ICU

    Measured: From study start to day 28

  3. Proportion of subjects requiring non-invasive mechanical ventilation

    Proportion of subjects requiring non-invasive mechanical ventilation

    Measured: From study start to day 28

  4. Proportion of subjects requiring invasive mechanical ventilation.

    Proportion of subjects requiring invasive mechanical ventilation.

    Measured: From study start to day 28

  5. Proportion of subjects with some organ failure

    Proportion of subjects with some organ failure

    Measured: From study start to day 28

  6. Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline

    Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline

    Measured: From study start to day 28

  7. Proportion of subjects with pathological angioTAC

    Proportion of subjects with pathological angioTAC at day 10 +/-1

    Measured: At day 10 +/-1

  8. Proportion of subjects with improvement in chest radiography

    Proportion of subjects with improvement in chest radiography

    Measured: At day 10 +/-1

  9. Proportion and median hospital discharge between patients in both groups.

    Proportion and median hospital discharge between patients in both groups.

    Measured: From study start to day 28

  10. Titration score

    Titration score

    Measured: From study start to day 28

  11. Ferritin score

    Ferritin score

    Measured: From study start to day 28

  12. D-dimer modification score

    D-dimer modification score

    Measured: From study start to day 28

  13. Adverse events (total and serious).

    Adverse events (total and serious)

    Measured: From study start to day 28

  14. Related adverse events (total and serious).

    Related adverse events (total and serious).

    Measured: From study start to day 28

  15. Clinically relevant major and non major hemorrhages.

    Clinically relevant major and non major hemorrhages.

    Measured: From study start to day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start4 Jun 2020
  3. Primary completion8 Jun 2021
  4. Study completion8 Jun 2021

Why it stopped: Lack of funding of the non-commercial sponsor to extend recruitment and reach the target number of patients specified in the protocol.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, single-blind, parallel control group
Masking
Single blind
Who is masked
Participant
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04420299
Sponsor's protocol ID
BEMICOVID-19
Other IDs
2020-001548-24
Status last verified
Jun 2022
First submitted
5 Jun 2020
Last updated
7 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

    PubMed 35244208

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bemiparin in people with Covid-19, run by Fundación de investigación HM at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of funding of the non-commercial sponsor to extend recruitment and reach the target number of patients specified in the protocol.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients that worsen (time frame: Day 10 +/- 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04420299, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.

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