A Two-Stage, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OP-101 (dendrimer n-acetyl-cysteine) in Patients with Severe COVID-19 Department of Medicine | College of Medicine – Jacksonville

A Two-Stage, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OP-101 (dendrimer n-acetyl-cysteine) in Patients with Severe COVID-19

Study Description

Ashvattha Therapeutics, Inc. has begun a clinical study of an investigational drug (also known as the "study drug") called OP-101 as a possible treatment for severe COVID-19 (coronavirus disease 2019). If the study doctor determines that a patient meets all of the inclusion criteria to be in the study, the participant will be provided an opportunity to enroll in the study.

As a study participant, You will have a 50% (1 in 2) chance of receiving OP-101 and a 50% (1 in 2) chance of receiving placebo. OP-101 or placebo will be administered by an IV infusion line (a small needle and tube placed into a vein in your arm by a member of your study healthcare team). The infusion will take about 60 minutes.

• OP-101 – two intravenous (IV) administrations of OP-101 (8 mg/kg), one on the first day and one three days later.
• Placebo – normal saline intravenous (IV) administered in the same way as OP-101, one on the first day and one three days later.

You will be in this study for about 2 months, and you will meet the study doctor or team approximately 10 times over this period, most of which will occur while you are in the hospital for the treatment of COVID-19 symptoms.

You will not be told which treatment you are receiving. The study doctor and any other people involved in the study will not know whether you are receiving OP-101 or a placebo. However, this information will be given to the study doctor if it becomes necessary for your safety. If this information needs to be shared for your safety, you will be asked to complete the procedures for the Early Termination Visit. The study doctor or staff will follow up on your health and symptoms until resolution and/or until Day 60 (Safety Follow-Up Visit).

You will receive supportive care (treatments to reduce your COVID-19 symptoms) while participating in this study, such as oxygen, intravenous fluids, medicines to keep your fever down, and/or have possible activity against the virus, and/or to treat your cough.

Investigators

Mehdi S. Mirsaeidi, M.D., M.P.H.
Medicine