ATTRACT3

Full Name

A randomized, double-blind, placebo-controlled, parallel group, phase 3, multicenter trial investigating the efficacy and safety of C21 as add on to standard of care in adult subjects with COVID-19.

Description

C21 may have a role in the treatment of SARS-CoV-2 virus. The trial will enroll a total of 600 randomized subjects globally, 300 per arm (oral C21 100 mg twice a day or placebo for 14 days) according to the 1:1 randomization. The trial is a blinded study where half of the patients will receive a placebo and half will receive active drug. All patients in study will receive standard of care to treat Covid-19.

Purpose: The primary objective is evaluating the use of C21 to treat hospitalized patients with moderate to severe symptoms of Covid-19. Although several therapeutic agents have been evaluated for the treatment of COVID-19, the morbidity and mortality are still significant. The need for safe, effective, and convenient COVID-19 drugs is likely to remain even after the launch of vaccine programs. The safety and efficacy of C21 in subjects with COVID-19 have been investigated in a phase 2 trial. The results show that C21, as add on to standard of care (SoC), reduced the need for extended oxygen supplementation and had a favorable benefit/risk profile. The rationale for conducting this phase 3 trial is to confirm the efficacy of C21 in subjects with COVID-19.

To Participate: Please contact the Network Office of Research and Innovation at 610-402-9543.

For additional information: https://clinicaltrials.gov/ct2/show/NCT04880642?term=efficacy+and+safety+of+C21+as+add+on+to+standard+of+care+in+adult+subjects+with+COVID-19.&draw=2&rank=1

Eligibility

Inclusion Criteria
  • 18 years or older
  • Confirmed positive PCR or antigen for SARS-CoV-2 within 3 days prior to randomization
  • Covid-19 illness less than 14 days of symptoms
  • Hospitalized on oxygen with mild to moderate Covid-19 symptoms
  • Adequate organ functioning
  • Willing to participate and comply with study procedures and duration.
Doctor(s) Running This Study