Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients (INHIXACOV19)
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|ClinicalTrials.gov Identifier: NCT04427098|
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 17, 2020
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.
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The study consists of two parts:
|Masking:||None (Open Label)|
|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|
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:
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
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
- 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
- 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.
- 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
- 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
- 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.
- 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.
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
|Contact: Andrea Romagnoli, MD||0039 050 email@example.com|
|Contact: Stefano Triscornia, BS||0039 050 firstname.lastname@example.org|
|Policlinico S. Orsola Malpighi Dipartimento Malattie Infettive||Recruiting|
|Bologna, Emilia Romagna, Italy, 40138|
|Contact: Pierluigi Viale, MD 00390516363353 email@example.com|
|Contact: Maddalena Giannella, MD 00390516363353 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Marco Baciarello, MD 0039 3280387722 firstname.lastname@example.org|
|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 email@example.com|
|Fondazione Poliambulanza Chirurgia Vascolare||Recruiting|
|Contact: Raffaello Bellosta, MD 00390303518255 firstname.lastname@example.org|
|Contact: Renzo Rossini, MD 0039Tel 0303515795 email@example.com|
|Piazzale Spedali Civili, 1, 25123 Brescia BS Medicina Interna UniBS 2° Medicina ASST Spedali Civili||Not yet recruiting|
|Contact: Massimo Salvetti, MD 00390303995251 firstname.lastname@example.org|
|Azienda Ospedaliero-Universitaria "Policlinico - V. Emanuele", Catania Anestesia e Rianimazione UO Malattie Infettive||Not yet recruiting|
|Contact: Arturo Montineri, MD 00390954794191 email@example.com|
|Contact: Marco Mangiafico, MD firstname.lastname@example.org|
|ASST Cremona Unità Operativa di Chirurgia Vascolare Dipartimento di Medicina di Laboratorio e di Radiologia- Centro Emostasi e Trombosi||Not yet recruiting|
|Contact: Sophie Testa, MD 0039 0372405111 email@example.com|
|Ospedale Morgagni Pierantoni U.O.C. Malattie Infettive||Recruiting|
|Contact: Francesco Cristini, MD 0039 3936022615 firstname.lastname@example.org|
|Contact: Aria Patacca, MD 0039 3280623035 email@example.com|
|Ospedale Carlo Poma di Mantova MALATTIE INFETTIVE Padiglione 37 Str. Lago Paiolo, 10, 46100 Mantova||Not yet recruiting|
|Contact: Salvatore Casari 0039 0376201539 firstname.lastname@example.org|
|AZIENDA OSPEDALIERA Regionale S CARLO POTENZA Struttura Complessa Interaziendale "Malattie Infettive"||Not yet recruiting|
|Contact: Giulio De Stefano, MD 0039 0835253344 email@example.com|
|Ospedale San Raffaele Unità Funzionale dell'Unità Operativa di Malattie Infettive Osp. San Raffaele||Not yet recruiting|
|Contact: Antonella Castagna, MD 0039 02 2643 5392 firstname.lastname@example.org|
|Ospedale Amedeo di Savoia Torino Università di Torino Malattie Infettive||Not yet recruiting|
|Contact: Giovanni Di Perri, MD 0039 0114393979 email@example.com|
|Contact: Stefano Bonorq, MD 0039 349193281 firstname.lastname@example.org|
|Azienda Ospedaliera Universitaria Integrata Verona UOC Malattie Infettive e Tropicali||Recruiting|
|Contact: Evelina Tacconelli, MD 00390458128284 email@example.com|
|Contact: Fulvia Mazzaferri, MD 0039 3387310642 firstname.lastname@example.org|
|Principal Investigator:||Pierluigi Viale, MD||Infectious Diseases Unit, Dep. Med. and Surg. Science University of Bologna|