COVID-19Phase 3BEMICOPNCT04604327
Comparison of Two Different Doses of Bemiparin in COVID-19
A Phase 3 study testing Bemiparin sodium in people with COVID-19, run by Clinica Universidad de Navarra, Universidad de Navarra at 12 sites in Spain.
Trial summary
Patients requiring hospitalization due to COVID-19 pneumonia (non-severe) will be randomized to standard prophylactic doses or full therapeutic dose of bemiparin (a LMWH) for 10 days. 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 sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 12 sitesSpain
- Study dates
- 26 Oct 2020to 31 Jul 2021
- Phase
- Phase 3
- 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
- Age (equal or more than 18 yo)
- Hospitalization at conventional wards due to COVID-19 related mild or moderate pneumonia (CURB65<3 points; Sat. O2>90%)
- 3-4 points according to the WHO ordinal scale.
- Confirmed COVID-19 (PCR or other validated test)
- D-dimer >500 ng/mL
- Sign of informed consent
- The patient is able, according to investigator's opinion, to deal with all the requirements of the clinical trial.
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites, 12 recruiting
- Not yet recruiting
Hospital Clinic
Barcelona
Sonia Jiménez
- Not yet recruiting
Hospital Sant Pau
Barcelona
David Filella
- Not yet recruiting
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat
Elena Pina
- Not yet recruiting
Fundación Jiménez Díaz
Madrid
Rosa Vidal
- Not yet recruiting
Hospital Clínico San carlos
Madrid
Ernesto Botella
- Not yet recruiting
Hospital Universitario La Paz
Madrid
Víctor Jiménez Yuste
- Not yet recruiting
Hospital Rey Juan Carlos
Móstoles, Madrid
Vanesa Sendín
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Ramón Lecumberri, MD, PhD, +34948255400, rlecumber@unav.es
- Not yet recruiting
Complejo Hospitalario de Navarra
Pamplona
Tania Galicia
- Not yet recruiting
Hospital Universitario de Salamanca
Salamanca
Miguel Marcos
- Not yet recruiting
Complejo Hospitalario de Toledo
Toledo
Jorge Cuesta
- Not yet recruiting
Hospital Universitario Río Hortega
Valladolid
Jessica Abadía
About this study
Official title: Ensayo clínico Aleatorizado, Abierto, Para Evaluar el Efecto de Dosis profilácticas o terapéuticas de Bemiparina en Pacientes Con COVID-19
Patients requiring hospitalization due to COVID-19 pneumonia (non-severe) will be randomized to standard prophylactic doses or full therapeutic dose of bemiparin (a LMWH) for 10 days.
- Conditions
- COVID-19
- Being tested
- Bemiparin sodium
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bemiparin sodiumDrug
Also called Hibor
Prophilactic vs full-dose for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic bemiparin (3,500 IU/day) | Active comparator | Bemiparin 3,500 IU daily for 10 days Receives: Drug: Bemiparin sodium |
| Full therapeutic bemiparin (weight adjusted) | Experimental | Bemiparin at full therapeutic dose, adjusted to body weight, for 10 days Receives: Drug: Bemiparin sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical deterioration
Combined outcome that includes number of patients who suffer any of the following: Death, ICU admission, mechanical ventilatory support, progression to moderate or severe ARDS (according to Berlin criteria) or arterial or venous thrombosis.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start26 Oct 2020 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramon Lecumberri, Md, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604327
- Sponsor's protocol ID
- BEMICOP
- Acronym
- BEMICOP
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 35244208Marcos-Jubilar M, Carmona-Torre F, Vidal R, Ruiz-Artacho P, Filella D, Carbonell C, Jimenez-Yuste V, Schwartz J, Llamas P, Alegre F, Sadaba B, Nunez-Cordoba J, Yuste JR, Fernandez-Garcia J, Lecumberri R; BEMICOP Investigators. Therapeutic versus Prophylactic Bemiparin in Hospitalized Patients with Nonsevere COVID-19 Pneumonia (BEMICOP Study): An Open-Label, Multicenter, Randomized, Controlled Trial. Thromb Haemost. 2022 Feb;122(2):295-299. doi: 10.1055/a-1667-7534. Epub 2021 Dec 29.
PubMed 34638151
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensayo clínico Aleatorizado, Abierto, Para Evaluar el Efecto de Dosis profilácticas o terapéuticas de Bemiparina en Pacientes Con COVID-19
- ClinicalTrials.gov ID
- NCT04604327
- Acronym / sponsor ID
- BEMICOP / BEMICOP
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 26 Oct 2020 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients requiring hospitalization due to COVID-19 pneumonia (non-severe) will be randomized to standard prophylactic doses or full therapeutic dose of bemiparin (a LMWH) for 10 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic bemiparin (3,500 IU/day) | Active comparator | Drug: Bemiparin sodiumBemiparin 3,500 IU daily for 10 days |
| Full therapeutic bemiparin (weight adjusted) | Experimental | Drug: Bemiparin sodiumBemiparin at full therapeutic dose, adjusted to body weight, for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age (equal or more than 18 yo)
- Hospitalization at conventional wards due to COVID-19 related mild or moderate pneumonia (CURB65<3 points; Sat. O2>90%)
- 3-4 points according to the WHO ordinal scale.
- Confirmed COVID-19 (PCR or other validated test)
- D-dimer >500 ng/mL
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bemiparin sodiumAlso: HiborProphilactic vs full-dose for 10 days | Drug | Full therapeutic bemiparin (weight adjusted), Prophylactic bemiparin (3,500 IU/day) |
Primary outcome
Clinical deterioration
Time frame: 10 days
Combined outcome that includes number of patients who suffer any of the following: Death, ICU admission, mechanical ventilatory support, progression to moderate or severe ARDS (according to Berlin criteria) or arterial or venous thrombosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Derived from this study: PubMed 35244208Flumignan 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.
- Derived from this study: PubMed 34638151Marcos-Jubilar M, Carmona-Torre F, Vidal R, Ruiz-Artacho P, Filella D, Carbonell C, Jimenez-Yuste V, Schwartz J, Llamas P, Alegre F, Sadaba B, Nunez-Cordoba J, Yuste JR, Fernandez-Garcia J, Lecumberri R; BEMICOP Investigators. Therapeutic versus Prophylactic Bemiparin in Hospitalized Patients with Nonsevere COVID-19 Pneumonia (BEMICOP Study): An Open-Label, Multicenter, Randomized, Controlled Trial. Thromb Haemost. 2022 Feb;122(2):295-299. doi: 10.1055/a-1667-7534. Epub 2021 Dec 29.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramon Lecumberri, Md, PhD principal investigator
University of Navarra
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bemiparin sodium in people with COVID-19, run by Clinica Universidad de Navarra, Universidad de Navarra at 12 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 7 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramon Lecumberri, MD, PhD (+34 948296397, rlecumber@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical deterioration (time frame: 10 days). 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 NCT04604327, which also lists 2 linked publications.
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 27 Oct 2020.