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Second trial of Transcrocetinate-sodium to Treat Acute Respiratory Distress Syndrome in COVID-19

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Trial Profile

Second trial of Transcrocetinate-sodium to Treat Acute Respiratory Distress Syndrome in COVID-19

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 23 Oct 2023

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At a glance

  • Drugs Transcrocetinate sodium (Primary)
  • Indications Adult respiratory distress syndrome; COVID 2019 infections
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors CervoMed; Diffusion Pharmaceuticals

Most Recent Events

  • 05 May 2020 According to an Diffusion Pharmaceuticals media release, under federal regulations, the FDA had up to 60 days from the company's April 24, 2020 submission to respond, but the FDA has announced its intention to significantly shorten review times for select COVID-19 submissions under its Coronavirus Treatment Acceleration Program (CTAP). Clinical trial preparations at multiple potential sites are continuing as the company awaits the FDA's expedited response.
  • 05 May 2020 According to an Diffusion Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) will accelerate its review of the company's clinical development plan using trans sodium crocetinate (TSC) in COVID-19 patients displaying severe respiratory symptoms and low oxygen levels. Similar to the FDA CTAP, health authorities in certain Eastern European countries have implemented emergency policies to compress regulatory review cycles from months to just days.
  • 04 May 2020 New trial record

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