Trial document




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  DRKS00024412

Trial Description

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Title

Quantification of the reduction on the viral load (SARS-CoV-2) on persons with COVID-19 after gargling with Linola sept mouthwash

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

It is planned to include 80 SARS-CoV-2 positive patients in this randomized controlled clinical trial (two arms, double blind). The patients will be recruited from hospitalized patients in the Hospital "Krankenhaus Bielefeld Mitte" and "Evangelisches Klinikum Bethel Bielefeld". The initially positive tested (SARS-CoV-2) persons will receive a pharyngeal test. Afterwards, they will gargle with the respective mouthwashes. They will use either Linola sept mouthwash (verum) or a placebo. Gargling will be performed for 2x20 seconds. After gargling, patients will receive a second pharyngeal testing. Both groups are planned to include 30 patients.
The swabs will be tested on the viral load (SARS-CoV-2) with the help of CT-values (cycle threshold). These analyses will help to quantify the viral load in the pharynx. The mouthwash will be used 2x daily (1-0-1).

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00024412
  •   2021/02/15
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  •   yes
  •   Approved
  •   2020-726, Ethikkommission der Medizinischen Fakultät der Ruhr-Universität Bochum, Sitz Bad Oeynhausen
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Secondary IDs

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Health Condition or Problem studied

  •   COVID-19
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Interventions/Observational Groups

  •   2x daily (1-0-1) use of the Linola sept mouthwash for 2x20 seconds at every use.
  •   2x daily (1-0-1) use of a placebo mouthwash for 2x20 seconds at every use.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Efficiency on the reduction of the temporary viral load of a mouthwash (Linola sept) after gargling.

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Secondary Outcome

Efficiency on the cumulative reduction of the viral load of a mouthwash (Linola sept) after gargling for more than 1 day.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2021/02/03
  •   80
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

-Willingness to participate
-Signed written consent
-Positive SARS-CoV-2 test using a pharyngeal swab
-CT-value < 37

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Exclusion Criteria

Allergies on at least one of the ingredients.

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Addresses

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    • Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde, Kopf- und Halschirurgie Campus Klinikum Bielefeld, Medizinische Fakultät OWL, Universität Bielefeld
    • Teutoburger Str. 50
    • 33604  Bielefeld
    • Germany
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    • Dr. Kurt Wolff GmbH & Co KG Research Department
    • Mr.  Dr.  Frederic  Meyer 
    • Johanneswerkstr. 34-36
    • 33611  Bielefeld
    • Germany
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    • Dr. Kurt Wolff GmbH & Co KG Research Department
    • Mr.  Dr.  Frederic  Meyer 
    • Johanneswerkstr. 34-36
    • 33611  Bielefeld
    • Germany
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Sources of Monetary or Material Support

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    • Dr. August Wolff GmbH & Co KG Arzneimittel
    • Sudbrackstraße 56
    • 33611  Bielefeld
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2022/03/22
  •   50
  •   50
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Trial Publications, Results and other Documents

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