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

Evergreen Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19 Pneumonia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04561180

HPC-EG-009A-2.1

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

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

Placebo Comparator group

Description:

In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A placebo for 3 additional weeks.

Treatment:

Drug: Dexamethasone

Drug: EG-009A Placebo

Drug: Standard of Care

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

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone

Drug: Standard of Care

Drug: EG-009A

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

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone

Drug: Standard of Care

Drug: EG-009A