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Open-label, Pharmacokinetic, Pharmacodynamic, Ascending Dose Safety lead-in Followed by a Single-center, Placebo-controlled, Double-blind, Adaptive, Safety and Efficacy, Pilot Study of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 Infected Subjects

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Trial Profile

Open-label, Pharmacokinetic, Pharmacodynamic, Ascending Dose Safety lead-in Followed by a Single-center, Placebo-controlled, Double-blind, Adaptive, Safety and Efficacy, Pilot Study of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 Infected Subjects

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 25 May 2022

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At a glance

  • Drugs Transcrocetinate sodium (Primary)
  • Indications Adult respiratory distress syndrome; COVID 2019 infections; Hypoxaemia
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms 100-303 COVID Trial
  • Sponsors Diffusion Pharmaceuticals

Most Recent Events

  • 27 Oct 2021 Status changed from recruiting to completed.
  • 12 Nov 2020 According to a Diffusion Pharmaceuticals media release, the company evaluating possibility of expanding 100-303 COVID Trial to include additional doses administered on the same regimen, assuming successful and timely completion of currently planned doses and final regulatory approval of pending protocol amendment to effect change.
  • 12 Nov 2020 According to a Diffusion Pharmaceuticals media release, as of November 11, 2020, patient enrollment continues, and no dose-limiting toxicities have been observed.

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