Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Wir wollen die Sicherheit und Wirksamkeit des Medikaments Enoxaparin, auch im Handel als Clexane® bekannt, welches zur Verhinderung von Blutgerinnseln (Thrombosen) seit vielen Jahren in der Schweiz zugelassen ist, bei Patienten mit Coronavirus-Infektion untersuchen. Dies wird bei nicht stationär aufgenommenen Patienten untersucht, die ambulant weiterbehandelt werden können (Heimquarantäne). Bisherige Befunde bei Patienten mit Coronavirus legen die Vermutung nahe, dass die Erkrankung zu einer vermehrten Blutgerinnselbildung (Thrombose) führen kann. Eine solche Thrombose kann als Komplikation zu einer Verstopfung von Blutgefässen der Lunge, das heisst Lungenembolie führen. Diese kann in schweren Fällen Herzversagen und den Tod verursachen. Es wurden auch weitere Gefässverstopfungen beschrieben einschliesslich Herzinfarkt, Schlaganfall und Durchblutungsstörungen des Darms und anderer Organe.
Die Verabreichung eines gerinnungshemmenden Medikamentes, in unserer Studie mit dem Wirkstoff Enoxaparin (Handelsname Clexane®), kann dem Auftreten einer Thrombose vorbeugen.
Malattie studiate(Fonte di dati: BASEC)
COVID-19
Health conditions
(Fonte di dati: WHO)
Pulmonary Embolism, Deep Vein Thrombosis
COVID-19
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Die Patienten werden in zwei Gruppen randomisiert, das heisst, sie werden per Zufall einer Gruppe zugeteilt. Die Behandlungsgruppe erhält für die Dauer von 14 Tagen eine Thromboseprophylaxe (Clexane), das heisst ein Arzneimittel zur Verhütung von Blutgerinnseln (Thrombosen) zur Injektion unter die Haut.
Die Kontrollgruppe erhält keine Thromboseprophylaxe, dies entspricht der gängigen Routine bei nichthospitalisierten COVID Patienten.
Interventions
(Fonte di dati: WHO)
Drug: Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
Es können alle erwachsenen Personen ab 50 Jahren teilnehmen, bei denen eine Infektion mit dem Coronavirus diagnostiziert wurde und welche ambulant weiterbehandelt werden können. Ausserdem müssen die Studienteilnehmer Symptome wie Husten, Halsschmerzen, Kurzatmigkeit oder Fieber
aufweisen.
Criteri di esclusione
(Fonte di dati: BASEC)
Nicht teilnehmen hingegen können Personen, die bereits eine Blutverdünnung erhalten oder bei denen gravierende Blutungsereignisse in der Vergangenheit aufgetreten sind.
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Inclusion Criteria:
1. Patients aged 50 years or older with a positive test for SARS-CoV2 in the past 5 days
and eligible for ambulatory treatment.
2. Presence of respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or
body temperature >37.5° C.
3. Ability of the patient to travel to the study center by private transportation,
performed either by accompanying person from same household or by the patient
him/herself
4. Ability to comply with standard hygiene requirements at the time of in-hospital visit,
including a face mask and hand disinfectant.
5. Ability to walk from car to study center or reach it using a wheel chair transport
with the help of an accompanying person from the same household also complying with
standard hygiene requirements.
6. Ability to self-administer prefilled enoxaparin injections after instructions received
at the study center or availability of a person living with the patient to administer
enoxaparin.
Exclusion Criteria:
1. Any acute or chronic condition posing an indication for anticoagulant treatment, e.g.
atrial fibrillation, prior VTE, acute confirmed symptomatic VTE, acute coronary
syndrome.
2. Anticoagulant thromboprophylaxis deemed necessary in view of the patient's history,
comorbidity or predisposing strong risk factors for thrombosis:
1. Any of the following events occurring in the prior 30 days: fracture of lower
limb, hospitalization for heart failure, hip/knee replacement, major trauma,
spinal cord injury, stroke,
2. previous VTE,
3. histologically confirmed malignancy, which was diagnosed or treated (surgery,
chemotherapy, radiotherapy) in the past 6 months, or recurrent, or metastatic, or
inoperable.
3. Any clinically relevant bleeding (defined as bleeding requiring hospitalization,
transfusion, surgical intervention, invasive procedures, occurring in a critical
anatomical site, or causing disability) within 30 days prior to randomization or sign
of acute bleeding.
4. Intracerebral bleeding at any time in the past or signs/symptoms consistent with acute
intracranial hemorrhage.
5. Hemoglobin <8 g/dL and platelet count <50 x 109 cells/L confirmed by recent laboratory
test (<90 days).
6. Subjects with any known coagulopathy or bleeding diathesis, including known
significant liver disease associated with coagulopathy.
7. Severe renal insufficiency (baseline creatinine clearance <30 mL/min calculated using
the Cockcroft-Gault formula) confirmed by recent laboratory test (<90 days).
8. Contraindications to enoxaparin therapy, including prior heparin-induced
thrombocytopenia and known hypersensitivity.
9. Current use of dual antiplatelet therapy.
10. Participation in other interventional studies over the past 30 days.
11. Non-compliance or inability to adhere to treatment or lack of a family environment or
support system for home treatment.
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
15 mag 2020
Inserimento del primo partecipante
15 giu 2020
Stato di reclutamento
Not recruiting
Titolo scientifico
(Fonte di dati: WHO)
Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With Coronavirus: The Multicenter Randomized Controlled Ovid Trial
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
Phase 3
Punti finali primari
(Fonte di dati: WHO)
all-cause death
hospitalizations
Punti finali secondari
(Fonte di dati: WHO)
Disseminated intravascular coagulation
all-cause death
Net clinical benefit
any hospitalizations
Number of cardiovascular events
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Basilea, Bellinzona, Berna, Deutschland, Deutschland
Freiburg, Ginevra, Mainz, Zurigo
Paesi di esecuzione
(Fonte di dati: WHO)
Germany, Switzerland
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Rebecca Spescha
+41 43 253 03 71
rebecca.spescha@usz.ch
Contatto per informazioni generali
(Fonte di dati: WHO)
Nils Kucher, Prof.
University of Zurich
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Kantonale
Ethikkommission Zürich
Data di autorizzazione da parte della commissione d’etica
28.05.2020
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2020-01157
Secondary ID (Fonte di dati: WHO)
OVID Trial
Torna alla panoramica