D24Fc as a Non-antiviral Immunomodulator in COVID-19 Treatment (SAC-COVID)
Clara Health

CD24Fc in COVID-19 Treatment (SAC-COVID)

Sponsored by OncoImmune


The study is designed as a randomized, placebo-controlled, double blind, multicenter, Phase III trial to compare two COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe COVID 19.

Preclinical and clinical studies have demonstrated that CD24Fc effectively address the major challenges associated with COVID-19.

About 
COVID-19

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.

How is this study designed?

Study Type: Interventional (Clinical Trial) Estimated Enrollment: 230 participants Primary Purpose: Treatment Actual Study Start Date: April 8, 2020 Estimated Study Completion Date: May 2022

Who is this study for?

Inclusion Criteria*:

  • Should be at least 18 years of age,
  • Male or female,
  • Diagnosed with COVID-19 and confirmed SARS-coV-2 viral infection.

Exclusion Criteria*:

  • Patients with COVID 19 in critical condition or ARDS (Appendix A) or NIAID 7-point ordinal score 2 (Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)).
  • Patients who are pregnant, breastfeeding, or have a positive pregnancy test result before enrollment.

* Additional criteria apply. Please speak with the study team for further information.

What should I expect?

Arm A: CD24Fc/Best Available Treatment; Arm B: placebo/ Best Available Treatment.

CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1. Total of 230 subjects will be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. All subjects will be treated with the best available treatment. The follow up period is 15 days.

Inpatient trial

Have questions or need help?

For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.