NCT04803227

Safety and Tolerability of Emricasan in Symptomatic Outpatients Diagnosed With Mild-COVID-19

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Histogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Treatments for COVID-19 are urgently needed. Emricasan (EMR) is a pan caspase inhibitor. Caspase-1 plays a role in a form of cell death called pyroptosis. EMR inhibits pyroptosis. The Investigators have shown that peripheral blood lymphocytes of COVID-19 patients overexpress caspase-1, providing evidence for pyroptosis. A recent European study corroborate the Investigators finding as they have shown evidence for the activation of the inflammasome in COVID-19.

Detailed description

A safety and tolerability study will be performed in 50 symptomatic outpatient mild-COVID-19 patients using Emricasan at 25mg BID dosing for 14 days with a 1:1 active: placebo of mild-COVID-19 patients receiving standard of care therapy. Although EMR has been extensively studied in humans in a total of 18 Phase 1 and Phase 2 studies, with an excellent safety and tolerance profile, it has not been used in the setting of COVID-19, therefore necessitating an initial safety and tolerability study looking at a no difference between AEs/SAEs for comparison between active and placebo group. The pharmacokinetics of EMR has been extensively studied; therefore, the Investigators will opportunistically sample patients at the end of the study to confirm that the Emricasan PK is not altered in COVID-19 patients. The primary endpoint will be cumulative incidence of AE/SAEs through day 14. Secondary endpoints will include various clinical and laboratory measures and patient reported outcomes (PROs) using a COVID-19-related assessment tool, SARS-CoV-2 viral PCR, titers of anti-SARS-CoV-2 neutralizing and quantitative antibodies and immunological studies as described in the protocol.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Emricasan	Emricasan 25 mg BID (days 1-14). Oral (capsule) administration.
OTHER	Placebo	Placebo BID \*days 1-14). Oral (capsule) administration.

Timeline

• Start date: 2021-03-11
• Primary completion: 2021-05-28
• Completion: 2021-05-28
• First posted: 2021-03-17
• Last updated: 2022-01-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study