COVID-19 PneumoniaPhase 2NCT04561180
Study to Evaluate the Efficacy and Safety of EG-009A Compared to DEX in Patients With COVID-19 Pneumonia
A Phase 2 study testing EG-009A and Dexamethasone in people with COVID-19 Pneumonia, run by Evergreen Therapeutics, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- EG-009A and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2022to 1 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
- 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.
About this study
Official title: 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.
- Conditions
- COVID-19 Pneumonia
- Being tested
- EG-009A, EG-009A Placebo, Standard of Care, Dexamethasone
- Keywords
- COVID 19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EG-009ADrug
Administered as an Intramuscular injection
EG-009A PlaceboDrug
Administered as an Intramuscular injection
Standard of CareDrug
Standard of Care Treatment for COVID-19 Infection
DexamethasoneDrug
The comparator, Administered as an Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: EG-009A; Drug: Standard of Care; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First dose date to 28 days treatment dosing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start4 Mar 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Why it stopped: No patients COVID-19 morbidity decreased.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evergreen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561180
- Sponsor's protocol ID
- HPC-EG-009A-2.1
- Status last verified
- Jul 2023
- First submitted
- 22 Sep 2020
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04561180
- Acronym / sponsor ID
- HPC-EG-009A-2.1
- Conditions
- COVID-19 Pneumonia
- Keywords
- COVID 19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients COVID-19 morbidity decreased.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Evergreen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: SOC + DEX + EG-009A placebo | Placebo comparator | Drug: EG-009A Placebo, Drug: Standard of Care, Drug: DexamethasoneIn addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A placebo for 3 additional weeks. |
| Arm 2: SOC + DEX + Low Dose EG-009A | Experimental | Drug: EG-009A, Drug: Standard of Care, Drug: DexamethasoneIn addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A Low dose for 3 additional weeks. |
| Arm 3: SOC + DEX + High Dose EG-009A | Experimental | Drug: EG-009A, Drug: Standard of Care, Drug: DexamethasoneIn addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A High dose for 3 additional weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EG-009AAdministered as an Intramuscular injection | Drug | Arm 2: SOC + DEX + Low Dose EG-009A, Arm 3: SOC + DEX + High Dose EG-009A |
| EG-009A PlaceboAdministered as an Intramuscular injection | Drug | Arm 1: SOC + DEX + EG-009A placebo |
| Standard of CareStandard of Care Treatment for COVID-19 Infection | Drug | Arm 1: SOC + DEX + EG-009A placebo, Arm 2: SOC + DEX + Low Dose EG-009A, Arm 3: SOC + DEX + High Dose EG-009A |
| DexamethasoneThe comparator, Administered as an Intravenous infusion | Drug | Arm 1: SOC + DEX + EG-009A placebo, Arm 2: SOC + DEX + Low Dose EG-009A, Arm 3: SOC + DEX + High Dose EG-009A |
Primary outcome
The proportion of patients alive and without respiratory failure
Time frame: First dose date to 28 days treatment dosing period
Patients will be assessed for COVID-19 Ordinal Scale for Clinical Improvement scores and respiratory status throughout the study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EG-009A and Dexamethasone in people with COVID-19 Pneumonia, run by Evergreen Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients alive and without respiratory failure (time frame: First dose date to 28 days treatment dosing period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.