Study to Evaluate the Efficacy and Safety of EG-009A Compared to DEX in Patients With COVID-19 Pneumonia

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of EG-009A Compared to Dexamethasone in Patients With Moderate/Severe (Non-intubated, Non-mechanical Ventilation) COVID-19 Pneumonia

To study signals of efficacy and safety of a currently available dosage form (IM) of EG-009A in reducing the severity of respiratory disease in patients hospitalized with SARS-CoV-2 virus.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Drug: Standard of Care; Drug: EG-009A Placebo; Drug: Dexamethasone; Drug: EG-009A

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18), or willing and able to provide assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures
2. Patient is aged at least 18 years, enrollment of patients < 65 years old will be limited to 20% of the total with the first 50% of enrollment conducted solely among those patients ≥ 55 years old.
3. Patient has SARS-CoV-2 pneumonia from COVID-19 infection of moderate to serious severity (WHO Ordinal Scale for Clinical Improvement score of 4 or 5)

4. Patient has COVID-19 symptoms ≤ 10 days and at least 1 of the following:

   • Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.)
   • O2 saturation (SpO2) ≤ 94% on room air
   • Requiring supplemental O2 (patients on HFNO ≤ 20 L/min with FiO2 < 0.5 are allowed), but not requiring mechanical ventilation.

Note: Patients admitted with immediate need for mechanical ventilation are of a severity too critical for inclusion into this protocol. Patients who are already in the hospital and have been removed from mechanical ventilation are not eligible.

Exclusion Criteria:

1. Patient has SARS-CoV-2 infection of severity ≥ 6 on COVID-19 WHO Ordinal Scale for Clinical Improvement or for those subjects who have a WHO Ordinal Scale for Clinical Improvement score of 5, nasal intermittent positive pressure ventilation (NIPPV) or requiring HFNO > 20 L/min with FiO2 ≥ 0.5 will be exclusionary.
2. Patient is currently receiving extracorporeal membrane oxygenation, nitric oxide therapy, or high-frequency oscillatory ventilation
3. Patient is unlikely to survive for > 24 hours from randomization, in the opinion of the investigator
4. Patient has a history of chronic oxygen use or any pre-existing respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
5. Patient has a history of venous thromboembolism, DVT, or pulmonary embolus
6. Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drug's PK, PD, or biological activity (if known), whichever is longer, prior to the first dose of study drug in this study or is currently participating in another clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 1: SOC + DEX + EG-009A placebo; In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A placebo for 3 additional weeks.	Drug: Standard of Care; Standard of Care Treatment for COVID-19 Infection; Drug: EG-009A Placebo; Administered as an Intramuscular injection; Drug: Dexamethasone; The comparator, Administered as an Intravenous infusion
Experimental: Arm 2: SOC + DEX + Low Dose EG-009A; In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A Low dose for 3 additional weeks.	Drug: Standard of Care; Standard of Care Treatment for COVID-19 Infection; Drug: Dexamethasone; The comparator, Administered as an Intravenous infusion; Drug: EG-009A; Administered as an Intramuscular injection
Experimental: Arm 3: SOC + DEX + High Dose EG-009A; In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A High dose for 3 additional weeks.	Drug: Standard of Care; Standard of Care Treatment for COVID-19 Infection; Drug: Dexamethasone; The comparator, Administered as an Intravenous infusion; Drug: EG-009A; Administered as an Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients alive and without respiratory failure	Patients will be assessed for COVID-19 Ordinal Scale for Clinical Improvement scores and respiratory status throughout the study	First dose date to 28 days treatment dosing period

Collaborators and Investigators

• Sponsor: Evergreen Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: COVID 19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: HPC-EG-009A-2.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No