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A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group, Adaptive Group-sequential Phase II Study, to Determine the Efficacy and Safety of BT086 as an Adjunctive Treatment in Severe Community Acquired Pneumonia (sCAP)

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group, Adaptive Group-sequential Phase II Study, to Determine the Efficacy and Safety of BT086 as an Adjunctive Treatment in Severe Community Acquired Pneumonia (sCAP)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Trimodulin (Primary)
  • Indications Community-acquired pneumonia
  • Focus Therapeutic Use
  • Acronyms CIGMA
  • Sponsors Biotest AG

    • Most Recent Events

    • 03 Apr 2020 According to a Biotest AG media release, Very good results have already been achieved in a large-scale Phase II study in mechanically ventilated patients with severe pneumonia (severe Community Acquired Pneumonia = sCAP) (CIGMA study). This group of diseases also includes pneumonia caused by the current coronavirus in critically ill patients.
    • 28 Jul 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 02 Feb 2015 Planned End Date changed from 1 May 2015 to 1 Mar 2015 as reported by ClinicalTrials.gov record.
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