Research & Development
Citius Files Addendum to Mino-Lok Phase 3 Trial Record Keeping Protocol to Advance Trials with COVID-19 Compliance
16 September 2020 - - US-based specialty pharmaceutical company Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) has filed an amendment to its Mino-Lok phase 3 protocol, the company said.

This amendment was designed to allow for more efficient follow-up and record-keeping of required clinical trial documentation given COVID-19 restrictions.

With personal visits having been severely restricted, Citius issued instructions in the form of file notes to sites in April and has now formalized these instructions.

The FDA released guidance on conduct of clinical trials of medical products during COVID-19 in March 2020, updated in July 2020.

Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialisation of critical care products, with a focus on anti-infectives and cancer care.

Mino-Lok is an antibiotic lock solution being developed as an adjunctive therapy in patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs).

CLABSIs/CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters and in hemodialysis patients, for whom venous access presents a challenge.

There are currently no approved therapies for salvaging infected CVCs.