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Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients (INHIXACOV19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04427098
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Pierluigi Viale, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Brief Summary:

General objective of the study To assess the efficacy and safety of enoxaparin in hospitalized patients with moderate to severe COVID-19 (Coronavirus Disease 2019) infection.

Study Design

The study consists of two parts:

  • a phase II single-arm interventional prospective study including all patients treated with the study drug;
  • an observational prospective cohort study including all patients screened for receiving the study drug but not included in the phase II study.

Patients will be enrolled from "date of study approval" for 1 month. Each patient will be followed-up for a minimum of 90 days after COVID19 diagnosis.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution Drug: Enoxaparin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The study consists of two parts:

  • a phase II single-arm interventional prospective study including all patients treated with the study drug;
  • an observational prospective cohort study including all patients screened for receiving the study drug but not included in the phase II study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermediate Dose Enoxaparin in Hospitalized Patients With Moderate-severe COVID19: A Pilot Phase II Single-arm Study, INHIXACOVID19
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: a phase II single-arm interventional prospective study

Patients included in the interventional study will receive subcutaneous enoxaparin in a single daily dose of:

  • 60 mg once daily in case of body weight of 45 to 60 kg
  • 80 mg per day in case of weight from 61 to 100 kg or
  • 100 mg once daily in case of bodyweight >100 kg

Enoxaparin will be started on the first day of COVID19 diagnosis and continued for 14 days.

Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution
Subcutaneous enoxaparin 40 mg once daily for 14 days.
Other Name: INHIXA 4,000 UI (40 mg) / 0.4 ml

Experimental: observational cohort study
Patients included in the observational cohort will will receive standard thrombo-prophylaxis with subcutaneous enoxaparin 40 mg/die
Drug: Enoxaparin
Subcutaneous enoxaparin for 14 days: 60 mg once daily in case of body weight of 45 to 60 kg; 80 mg once daily in case of weight from 61 to 100 kg; 100 mg once daily in case of bodyweight >100 kg
Other Names:
  • INHIXA 6,000 UI (60 mg) / 0.6 ml
  • INHIXA 8,000 UI (80 mg) / 0.8 ml
  • INHIXA 10,000 UI (100 mg)/ 1 ml




Primary Outcome Measures :
  1. To investigate the efficacy of enoxaparin in improving the clinical outcome of hospitalized patients with moderate-severe COVID-19. [ Time Frame: 30 days and 90 days from the first LMWH subcutaneous injection ]
    Rates of hospitalized patients dead for all-cause within 30 days and 90 days from the first LMWH subcutaneous injection

  2. To investigate the efficacy of enoxaparin in improving the clinical outcome of hospitalized patients with moderate-severe COVID-19. [ Time Frame: This evaluation will be performed at 30 days and 90 days from the first LMWH subcutaneous injection ]
    Based on the four levels scale of severity of symptoms. Any change from one level to another will be detected for all the enrolled patients, in order to evalutate the clinical efficacy of enoxaparin on the outcome of COVID 19.

  3. To investigate the efficacy of enoxaparin in improving the clinical outcome of hospitalized patients with moderate-severe COVID-19. [ Time Frame: This evaluation will be performed at 14 days (the last day of treatment adminstration), at 30 days and 90 days from the first LMWH subcutaneous injection ]
    Evolution of the clinical severity during treatment, based on the number and rate of patients admitted to ICU and the length of their ICU stay

  4. To investigate the efficacy of enoxaparin in improving the clinical outcome of hospitalized patients with moderate-severe COVID-19. [ Time Frame: This evaluation will be performed at 90 days from admission ]
    Difference between groups in number of days of hospitalization from admission to discharge


Secondary Outcome Measures :
  1. To analyse the safety of enoxaparin in hospitalized patients with moderatesevere COVID-19. [ Time Frame: 45 days ]

    Rate of adverse events (AEs) during treatment, at the end of treatment (EOT) and at 30 days after EOT.

    • Severity of AEs classified according to common terminology criteria for adverse events (CTCAE). The worst degree ever suffered will be considered.


  2. To describe the rates and the types of thromboembolic events among hospitalized patients with confirmed diagnosis of COVID-19. [ Time Frame: 90 days ]
    Occurrence of thromboembolic event at 90 days after COVID-19 diagnosis. Description of the type, distribution and severity of thromboembolic events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For both interventional study and observational cohort, hospitalized patients are eligible to be included if the following criteria apply:

Inclusion criteria:

  • Age >=18 y
  • Microbiologically confirmed COVID-19 infection
  • Patients with moderate to severe disease according to study definitions (see below)
  • Informed consent to participate and to use data for interventional study, only to use data for observational cohort

Exclusion Criteria:

  • Participants are excluded from the interventional study if any of the following criteria apply:

    • Thrombocytopenia (platelet count < 50.000 mm3)
    • Coagulopathy: INR (International normalized ratio) >1.5, aPTT ratio >1.4
    • Impaired renal function (clearance to creatinine less than 15 ml/min)
    • Known hypersensitivity to heparin
    • History of heparin induced thrombocytopenia
    • Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignant tumors at hig risk of haemorrhages, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations)
    • Body weight <45 or > 150 kg
    • Concomitant anticoagulant treatment for other indications ( eg atrial fibrillation, venous thromboembolism , prosthetic heart valves).
    • Dual antiplatelet therapy
    • Pregnant or breast-feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427098


Contacts
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Contact: Andrea Romagnoli, MD 0039 050 0984040 aromagnoli@ricerchenuove.com
Contact: Stefano Triscornia, BS 0039 050 0984040 striscornia@ricerchenuove.com

Locations
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Italy
Policlinico S. Orsola Malpighi Dipartimento Malattie Infettive Recruiting
Bologna, Emilia Romagna, Italy, 40138
Contact: Pierluigi Viale, MD    00390516363353    pierluigi.viale@unibo.it   
Contact: Maddalena Giannella, MD    00390516363353    maddalena.giannella@unibo.it   
Azienda Ospedaliero-Universitaria di Parma Anestesia e Rianimazione Dipartimento di Medicina e Chirurgia Not yet recruiting
Parma, Emilia Romagna, Italy
Contact: Elena Giovanna Bignami, MD    0039 3388326680    elenagiovanna.bignami@unipr.it   
Contact: Marco Baciarello, MD    0039 3280387722    marco.baciarello@unipr.it   
I.R.C.C.S. "Casa Sollievo della Sofferenza", San Giovanni Rotondo (FG) UOVD Emostasi e trombosi- Poliambulatorio Giovanni Paolo II Viale Padre Pio n.7 San Giovanni Rotondo (FG) Recruiting
San Giovanni Rotondo, Foggia, Italy
Contact: Elvira Grandone, MD    0039 0882416286    elvira.grandone@operapadrepio.it   
Fondazione Poliambulanza Chirurgia Vascolare Recruiting
Brescia, Italy
Contact: Raffaello Bellosta, MD    00390303518255    raffaello.bellosta@poliambulanza.it   
Contact: Renzo Rossini, MD    0039Tel 0303515795    renzo.rossini@poliambulanza.it   
Piazzale Spedali Civili, 1, 25123 Brescia BS Medicina Interna UniBS 2° Medicina ASST Spedali Civili Not yet recruiting
Brescia, Italy
Contact: Massimo Salvetti, MD    00390303995251    massimo.salvetti@unibs.it   
Azienda Ospedaliero-Universitaria "Policlinico - V. Emanuele", Catania Anestesia e Rianimazione UO Malattie Infettive Not yet recruiting
Catania, Italy
Contact: Arturo Montineri, MD    00390954794191    a.montineri@libero.it   
Contact: Marco Mangiafico, MD       marcomangiafico@hotmail.it   
ASST Cremona Unità Operativa di Chirurgia Vascolare Dipartimento di Medicina di Laboratorio e di Radiologia- Centro Emostasi e Trombosi Not yet recruiting
Cremona, Italy
Contact: Sophie Testa, MD    0039 0372405111    s.testa@asst-cremona.it   
Ospedale Morgagni Pierantoni U.O.C. Malattie Infettive Recruiting
Forlì, Italy
Contact: Francesco Cristini, MD    0039 3936022615    francesco.cristini@auslromagna.it   
Contact: Aria Patacca, MD    0039 3280623035    aria.patacca@auslromagna.it   
Ospedale Carlo Poma di Mantova MALATTIE INFETTIVE Padiglione 37 Str. Lago Paiolo, 10, 46100 Mantova Not yet recruiting
Mantova, Italy
Contact: Salvatore Casari    0039 0376201539    salvatore.casari@asst-mantova.it   
AZIENDA OSPEDALIERA Regionale S CARLO POTENZA Struttura Complessa Interaziendale "Malattie Infettive" Not yet recruiting
Matera, Italy
Contact: Giulio De Stefano, MD    0039 0835253344    giulio.destefano@ospedalesancarlo.it   
Ospedale San Raffaele Unità Funzionale dell'Unità Operativa di Malattie Infettive Osp. San Raffaele Not yet recruiting
Milano, Italy
Contact: Antonella Castagna, MD    0039 02 2643 5392    castagna.antonella@hsr.it   
Ospedale Amedeo di Savoia Torino Università di Torino Malattie Infettive Not yet recruiting
Torino, Italy
Contact: Giovanni Di Perri, MD    0039 0114393979    giovanni.diperri@unito.it   
Contact: Stefano Bonorq, MD    0039 349193281    stefano.bonora@unito.it   
Azienda Ospedaliera Universitaria Integrata Verona UOC Malattie Infettive e Tropicali Recruiting
Verona, Italy
Contact: Evelina Tacconelli, MD    00390458128284    evelina.tacconelli@univr.it   
Contact: Fulvia Mazzaferri, MD    0039 3387310642    fulvia.mazzaferri@aovr-veneto.it   
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
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Principal Investigator: Pierluigi Viale, MD Infectious Diseases Unit, Dep. Med. and Surg. Science University of Bologna
  Study Documents (Full-Text)

Documents provided by Pierluigi Viale, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
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Responsible Party: Pierluigi Viale, Professor of Infectious Diseases, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT04427098    
Other Study ID Numbers: 2020-001308-40
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action