Brief description of trial (Data source: BASEC)
Ziel der Studie ist es, zu untersuchen, ob das Studienmedikament (Aviptadil) einen positiven Einfluss auf
die Genesung bei Infizierten mit dem neuartigen Coronavirus hat. Dabei wird die Studie in zwei Gruppen
aufgeteilt. Eine Gruppe erhält das Aviptadil auf drei Dosen von jeweils 67μg über den Tag verteilt,
während die andere Gruppe ein Kontrollpräparat ohne Wirkung verabreicht bekommt (NaCl 0.9%). Dabei
weiss weder der Arzt, noch der Proband, welcher Gruppe er zugeordnet ist, um mögliche Fehlergebnisse
zu vermeiden. Die Studie findet an drei Standorten in der Schweiz statt-Kantonsspital Baselland, Kantonsspital St. Gallen und Spital Schwyz.
Health conditions investigated(Data source: BASEC)
Untersucht wird die Krankheit COVID-19 und das damit einhergehende akute Atemwegssyndrom (ARDS).
Health conditions
(Data source: WHO)
Covid19;Corona Virus Infection;ARDS;Aviptadil
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Untersucht wird der Einfluss des Studienmedikaments Aviptadil bei Patienten mit COVID-19 und erhöhtem Risiko für akutes Atemwegssyndrom (ARDS)
Interventions
(Data source: WHO)
Drug: Aviptadil 67?g;Drug: Placebo 0.9% NaCl solution
Criteria for participation in trial
(Data source: BASEC)
- bekannte COVID-19 Infektion, diagnostiziert nach den Kriterien des
Kantonsspital Baselland
- Risikofaktoren, welche die Entstehung eines ARDS begünstigen
- Patient ist fähig die Einwilligungserklärung zu unterschreiben
Exclusion criteria
(Data source: BASEC)
- Mechanische Beatmung
- Unfähigkeit, Inhalationstherapie durchzuführen
- Schwere Komorbiditäten, die die sichere Teilnahme an der Studie in Frage
stellen
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- COVID-19 infection diagnosed
- Risk factors for the development of an ARDS according to an adapted EALI (early acute
lung injury score) = 2 Points (with at least one point from the EALI score)
EALI Score:
- 2-6l O2 supplementation to achieve a SaO2>90%: 1 point
- >6l O2 supplementation to achieve a SaO2>90%: 2 points
- Respiratory rate = 30/min: 1 point
- Immunosuppression: 1 Point
Modification (for adapting for risk factors for ARDS in SARS-CoV-2 affected patients
- Arterial hypertension: 1 point
- Diabetes: 1 point
- Fever > 39?C: 1 point
- Age > 18 years
- Ability to adequate compliance with the inhalation manoeuvre
- Ability to sign the informed consent
Exclusion Criteria:
- Known or highly suspected bacterial infection (antibiotic treatment to avoid bacterial
superinfection may be allowed)
- PCT = 1?g/l
- Mechanical ventilation
- Inability to conduct inhalation therapy
- Hemodynamic instability with requirement of vasopressor therapy
- Severe comorbidities interfering with the safe participation at the trial according to
the treating physician
- Pregnancy
- Systemic immunosuppression
-
Further information on trial
Recruitment status
Terminated
Academic title
(Data source: WHO)
Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS: A Randomized, Placebo Controlled, Multicenter 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: Double (Participant, Investigator).
Phase
(Data source: WHO)
Phase 2
Primary end point
(Data source: WHO)
Time to clinical improvement
Secundary end point
(Data source: WHO)
Frequency of mechanical ventilation;Oxygen supplementation;SaO2;FiO2;C-reactive Protein;Neutrophile;lymphocyte;Interleukine 6;Procalcitonin;Frequency of Multi organ dysfunction Syndrome (MODS)
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 information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel, Schwyz, St. Gallen, Wien (Austria)
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Jörg D. Leuppi
+41 61 925 2180
joerg.leuppi@ksbl.ch
Contact for general information
(Data source: WHO)
J?rg D Leuppi, Professor
Cantonal Hosptal, Baselland
Contact for scientific information
(Data source: WHO)
J?rg D Leuppi, Professor
Cantonal Hosptal, Baselland
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
03.12.2020
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2020-01902
Back to overview
