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

NCT04561180 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: HPC-EG-009A-2.1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

COVID-19 Pneumonia

Keywords

COVID 19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Arm 1: SOC + DEX + EG-009A placebo

PLACEBO COMPARATOR

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: EG-009A Placebo; Drug: Standard of Care; Drug: Dexamethasone

Arm 2: SOC + DEX + Low Dose EG-009A

EXPERIMENTAL

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: EG-009A; Drug: Standard of Care; Drug: Dexamethasone

Arm 3: SOC + DEX + High Dose EG-009A

EXPERIMENTAL

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: EG-009A; Drug: Standard of Care; Drug: Dexamethasone

Interventions

EG-009A DRUG

Administered as an Intramuscular injection

Arm 2: SOC + DEX + Low Dose EG-009A; Arm 3: SOC + DEX + High Dose EG-009A

EG-009A Placebo DRUG

Administered as an Intramuscular injection

Arm 1: SOC + DEX + EG-009A placebo

Standard of Care DRUG

Standard of Care Treatment for COVID-19 Infection

Arm 1: SOC + DEX + EG-009A placebo; Arm 2: SOC + DEX + Low Dose EG-009A; Arm 3: SOC + DEX + High Dose EG-009A

Dexamethasone DRUG

The comparator, Administered as an Intravenous infusion

Arm 1: SOC + DEX + EG-009A placebo; Arm 2: SOC + DEX + Low Dose EG-009A; Arm 3: SOC + DEX + High Dose EG-009A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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)
• 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.

You may not qualify if:

• Patient is currently receiving extracorporeal membrane oxygenation, nitric oxide therapy, or high-frequency oscillatory ventilation
• Patient is unlikely to survive for \> 24 hours from randomization, in the opinion of the investigator
• Patient has a history of chronic oxygen use or any pre-existing respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
• Patient has a history of venous thromboembolism, DVT, or pulmonary embolus
• 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.

Sponsors & Collaborators

• Evergreen Therapeutics, Inc.: lead

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care; Dexamethasone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 23, 2020
• Study Start: March 4, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07