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SNCTP000003950 | NCT04400799 | BASEC2020-01157

Studie zur Verhinderung von Blutgerinnseln mit Clexane® bei ambulanten Patienten mit Coronavirus-Infektion

Data source: BASEC (Imported from 22.09.2021), WHO (Imported from 18.04.2021)
Changed: 15.09.2021
Disease category: Infections and Infestations, Arterial and venous diseases including deep venous thrombosis and lung embolism

Brief description of trial (Data source: 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.

Health conditions investigated (Data source: BASEC)

COVID-19

Health conditions (Data source: WHO)

COVID-19;Pulmonary Embolism, Deep Vein Thrombosis

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: 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 (Data source: WHO)

Drug: Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml

Criteria for participation in trial (Data source: 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.

Exclusion criteria (Data source: BASEC)

Nicht teilnehmen hingegen können Personen, die bereits eine Blutverdünnung erhalten oder bei denen gravierende Blutungsereignisse in der Vergangenheit aufgetreten sind.

Inclusion/Exclusion Criteria (Data source: 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.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT04400799

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT04400799

Further information on trial

Date trial registered

15.05.2020

Incorporation of the first participant

15.06.2020

Recruitment status

Recruiting

Academic title (Data source: WHO)

Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With Coronavirus: The Multicenter Randomized Controlled Ovid Trial

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

all-cause death;hospitalizations

Secundary end point (Data source: WHO)

Disseminated intravascular coagulation;Net clinical benefit;all-cause death;any hospitalizations;Number of cardiovascular events

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

No

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Basel, Bellinzona, Bern, Geneva, Lausanne, Lugano, Zurich

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Rebecca Spescha
+41 43 253 03 71
rebecca.spescha@usz.ch

Contact for general information (Data source: WHO)

Nils Kucher, Prof.
University of Zurich
+41442552671
nils.kucher@usz.ch

Contact for scientific information (Data source: WHO)

Nils Kucher, Prof.
University of Zurich
+41442552671
nils.kucher@usz.ch

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

University of Zurich

Additional sponsors (Data source: WHO)

University Hospital Inselspital, Berne;University Hospital, Geneva;Centre Hospitalier Universitaire Vaudois;University Hospital, Basel, Switzerland;Oncology Institute of Southern Switzerland;Clinica Luganese Moncucco

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

04.06.2020

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2020-01157

Secondary ID (Data source: WHO)

OVID Trial