Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients

NCT04427098 | Completed Phase 2 DMC

• 1 other identifier: 2020-001308-40
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 13

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

• Mortality

  Rates of hospitalized patients dead for all-cause within 30 days and 90 days from the first LMWH subcutaneous injection

  30 days and 90 days from the first LMWH subcutaneous injection

• Effectivness of enoxaparin on the outcome of COVID 19.

  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.

  This evaluation will be performed at 30 days and 90 days from the first LMWH subcutaneous injection

• ICU admission and length of ICU stay

  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

  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

• Lenght of hospital stay

  Difference between groups in number of days of hospitalization from admission to discharge

  This evaluation will be performed at 90 days from admission

Secondary Outcomes (2)

• To describe the rates and the types of thromboembolic events among hospitalized patients with confirmed diagnosis of COVID-19.

  90 days

• Advers Events

  45 days

Study Arms (2)

a phase II single-arm interventional prospective study

ACTIVE COMPARATOR

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

observational cohort study

EXPERIMENTAL

Patients included in the observational cohort will will receive standard thrombo-prophylaxis with subcutaneous enoxaparin 40 mg/die

Drug: Enoxaparin

Interventions

Enoxaparin 40 Mg/0.4 mL Injectable Solution DRUG

Subcutaneous enoxaparin 40 mg once daily for 14 days.

Also known as: INHIXA 4,000 UI (40 mg) / 0.4 ml

a phase II single-arm interventional prospective study

Enoxaparin DRUG

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

Also known as: 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

observational cohort study

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (13)

Policlinico S. Orsola Malpighi Dipartimento Malattie Infettive

Bologna, Emilia-Romagna, 40138, Italy

Location

Azienda Ospedaliero-Universitaria di Parma Anestesia e Rianimazione Dipartimento di Medicina e Chirurgia

Parma, Emilia-Romagna, Italy

Location

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)

San Giovanni Rotondo, Foggia, Italy

Location

Fondazione Poliambulanza Chirurgia Vascolare

Brescia, Italy

Location

Piazzale Spedali Civili, 1, 25123 Brescia BS Medicina Interna UniBS 2° Medicina ASST Spedali Civili

Brescia, Italy

Location

Azienda Ospedaliero-Universitaria "Policlinico - V. Emanuele", Catania Anestesia e Rianimazione UO Malattie Infettive

Catania, Italy

Location

ASST Cremona Unità Operativa di Chirurgia Vascolare Dipartimento di Medicina di Laboratorio e di Radiologia- Centro Emostasi e Trombosi

Cremona, Italy

Location

Ospedale Morgagni Pierantoni U.O.C. Malattie Infettive

Forlì, Italy

Location

Ospedale Carlo Poma di Mantova MALATTIE INFETTIVE Padiglione 37 Str. Lago Paiolo, 10, 46100 Mantova

Mantova, Italy

Location

AZIENDA OSPEDALIERA Regionale S CARLO POTENZA Struttura Complessa Interaziendale "Malattie Infettive"

Matera, Italy

Location

Ospedale San Raffaele Unità Funzionale dell'Unità Operativa di Malattie Infettive Osp. San Raffaele

Milan, Italy

Location

Ospedale Amedeo di Savoia Torino Università di Torino Malattie Infettive

Torino, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona UOC Malattie Infettive e Tropicali

Verona, Italy

Location

Related Publications (1)

• Cosmi B, Giannella M, Fornaro G, Cristini F, Patacca A, Castagna A, Mazzaferri F, Testa S, Pan A, Lupi M, Brambilla P, Montineri A, Frattima S, Bignami EG, Salvetti M, De Stefano G, Grandone E, Di Perri G, Rozzini R, Stella A, Romagnoli A, Drago F, Viale P. Intermediate dose enoxaparin in hospitalized patients with moderate-severe COVID-19: a pilot phase II single-arm study, INHIXACOVID19. BMC Infect Dis. 2023 Oct 24;23(1):718. doi: 10.1186/s12879-023-08297-7.

  PMID: 37875792 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Pierluigi Viale, MD

  Infectious Diseases Unit, Dep. Med. and Surg. Science University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Infectious Diseases

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 11, 2020
• Study Start: May 22, 2020
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: December 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (13)