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SNCTP000004207 | NCT04501978 | BASEC2020-02923

Eine multizentrische, adaptive, randomisierte, Placebo-kontrollierte Doppelblindstudie zur Wirksamkeit, Sicherheit und Verträglichkeit von experimentellen Therapeutika zur Behandlung von COVID-19 bei hospitalisierten Patienten

Data source: BASEC (Imported from 20.01.2021), WHO (Imported from 17.01.2021)
Changed: 12.01.2021
Disease category: Infections and Infestations

Brief description of trial (Data source: BASEC)

Diese Studie untersucht die Medikamentengruppe der neutralisierenden monoklonalen Antikörper. Diese Gruppe wurde bereits zur Behandlung von vielen anderen Krankheiten zugelassen, zur Behandlung von COVID-19 aber noch nicht. Wir wollen im Rahmen dieser Studie untersuchen, ob diese Antikörper dazu beitragen können, den Krankheitsverlauf von COVID-19 zu verbessern und ob dies möglicherweise hilft, schneller zu genesen und aus dem Spital entlassen zu werden. Ausserdem überprüfen wir die Sicherheit und Verträglichkeit dieser Medikamente.

Health conditions investigated (Data source: BASEC)

Coronavirus SARS-CoV-2-Infektion (COVID-19)

Health conditions (Data source: WHO)

Covid19

Rare disease (Data source: BASEC)

No

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

In dieser Studie werden verschiedene monoklonale neutralisierende Antikörper zur Behandlung von COVID-19 untersucht. Studienteilnehmer werden automatisch einem der aktuell untersuchten Antikörper oder Placebo zugewiesen. Dies wird nach dem Zufallsprinzip geschehen, entsprechend einem Würfelwurf. Zusätzlich zum experimentellen Medikament (oder Placebo), erhalten alle Studienteilnehmer die indizierte Standardtherapie für COVID-19 (z.B. Veklury® und/oder Dexamethason).

Interventions (Data source: WHO)

Drug: LY3819253
Drug: Placebo
Drug: Remdesivir

Criteria for participation in trial (Data source: BASEC)

1) Alter 18 Jahre oder mehr
2) Einwilligung zur Studienteilnahme durch den Patienten oder gesetzlichen Vertreter/Angehöriger
3) Nachgewiesene SARS-CoV-2-Infektion
4) Dauer der auf COVID-19 zurückzuführenden Symptome für 12 Tage oder weniger
5) Stationären Aufnahme zur Behandlung von COVID-19

Exclusion criteria (Data source: BASEC)

1) Vorheriger Erhalt von: a) SARS-CoV-2 Rekonvaleszenten Plasma oder b) SARS-CoV-2 neutralisierende monoklonale Antikörper
2) Parallele Teilnahme an anderen COVID-19-Behandlungsstudien bis zum fünften Tag der Studienteilnahme (wenige Ausnahmen sind im Studienprotokoll detailliert)
3) Frauen im gebärfähigem Alter (die bei Studienbeginn noch nicht schwanger sind) und Männer, die nicht bereit sind, die ausdrückliche Empfehlung zur sicheren Empfängnisverhütung während der gesamten Studie, zur Kenntnis zu nehmen.

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- Signed informed consent.

- Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19
infection.

- Symptoms of COVID-19 for = 12 days.

- Require admission to hospital for acute medical care (not for purely public health or
quarantine purposes).

Exclusion Criteria:

- Patients who have received plasma from a person who recovered from COVID-19 or who
have received neutralizing monoclonal antibodies at any time prior to hospitalization.

- Patients not willing to abstain from participation in other COVID-19 treatment trials
until after Day 5 of the study.

- Any condition which, in the opinion of the responsible investigator, participation
would not be in the best interest of the participant or that could prevent, limit, or
confound the protocol-specified assessments.

- Patients considered unable to participate in study procedures.

- Women of child-bearing potential who are not already pregnant at study entry and who
are unwilling to abstain from sexual intercourse with men, or practice appropriate
contraception through Day 90 of the study.

- Men who are unwilling to abstain from sexual intercourse with women of child-bearing
potential or who are unwilling to use barrier contraception through Day 90 of the
study.

- [Stage 1 only] Presence at study enrollment of any of the following:

1. stroke

2. meningitis

3. encephalitis

4. myelitis

5. myocardial ischemia

6. myocarditis

7. pericarditis

8. symptomatic congestive heart failure

9. arterial or deep venous thrombosis or pulmonary embolism

- [Stage 1 only] Current or imminent requirement for any of the following:

1. invasive mechanical ventilation

2. ECMO (extracorporeal membrane oxygenation)

3. Mechanical circulatory support

4. vasopressor therapy

5. commencement of renal replacement therapy at this admission (i.e. not patients on
chronic renal replacement therapy).

Other investigational drug protocol-defined inclusion/exclusion criteria may apply.

Minimum age: 18 Years
Maximum age: N/A
Sex: All

Further information on the trial in WHO primary registry

http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT04501978

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT04501978

Further information on trial

Date trial registered

03.08.2020

Incorporation of the first participant

04.08.2020

Recruitment status

Not recruiting

Global completion date of trial

30.11.-0001

Academic title (Data source: WHO)

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

Pulmonary ordinal outcome (Stage 1)
Pulmonary+ ordinal outcome (Stage 1)
Time from randomization to sustained recovery (Stage 2)

Secundary end point (Data source: WHO)

All-cause mortality
Change in neutralizing antibody levels
Change in New Early Warning (NEW) Score
Change in overall titers of antibodies
Change in SARS-CoV-2 neutralizing antibody levels
Composite of cardiovascular events and thromboembolic events
Composite of death or serious clinical COVID-19 related events
Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death
Composite of SAEs or death
Composite of time to sustained recovery and mortality
Days alive outside short-term acute care hospital
Incidence of clinical organ failure
Incidence of infusion reactions
Pulmonary ordinal outcome
Pulmonary+ ordinal outcome

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)

Zurich, international

Countries (Data source: WHO)

Switzerland might not appear as site of trial if it has not yet been entered as such in the WHO primary registry.
Denmark, Singapore, Spain, United States

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Prof. Dr. med. Huldrych Guenthard
+41 44 255 34 50
huldrych.guenthard@usz.ch

Contact for general information (Data source: WHO)

Prof. James Neaton
INSIGHT Statistical and Coordinating Centre, University of Minnesota

Contact for scientific information (Data source: WHO)

Prof. Jens Lundgren
INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

National Institute of Allergy and Infectious Diseases (NIAID)

Additional sponsors (Data source: WHO)

AIDS Clinical Trials Group
Cardiothoracic Surgical Trials Network (CTSN)
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Kirby Institute
Medical Research Council
National Heart, Lung, and Blood Institute (NHLBI)
Prevention and Early Treatment of Acute Lung Injury (PETAL)
University of Copenhagen
US Department of Veterans Affairs
Washington D.C. Veterans Affairs Medical Center

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

07.01.2021

Further trial identification numbers

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

2020-02923

Secondary ID (Data source: WHO)

014 / ACTIV-3