COVID-19Phase 2NCT04500132
To Evaluate Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia
A Phase 2 study testing EC-18 in people with COVID-19, run by Enzychem Lifesciences Corporation at 1 site in South Korea.
Trial summary
Prevention of COVID-19 infection to severe pneumonea or ARDS Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- EC-18
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 May 2020to 15 Feb 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Male or female age 19 years or older
- Pathologically confirmed diagnosis of COVID-19 Infection to Pneumonia
Who cannot join
- Pathologically confirmed diagnosis of bacterial pneumonia or viral pneumonia
- Pregnant or nursing at the time of signing informed consent
- Known sensitivity to any study medication
- Unwilling or unable to complete study diary
- Any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2, Multi-center, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia
Prevention of COVID-19 infection to severe pneumonea or ARDS
- Conditions
- COVID-19
- Being tested
- EC-18, Placebo EC-18
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC-18Drug
EC-18 QD
Placebo EC-18Drug
Placebo EC-18 QD
| Study group | Role | What they receive |
|---|---|---|
| EC-18 Arm | Experimental | EC-18 QD Receives: Drug: EC-18 |
| Placebo Arm | Placebo comparator | Placebo EC-18 QD Receives: Drug: Placebo EC-18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of transition to ARDS
Measured: 14 days after starting IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start28 May 2020
- Primary completion4 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzychem Lifesciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyewon Jeong, Principal investigator, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500132
- Sponsor's protocol ID
- EC-18-C201
- Status last verified
- Feb 2022
- First submitted
- 4 Aug 2020
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multi-center, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia
- ClinicalTrials.gov ID
- NCT04500132
- Acronym / sponsor ID
- EC-18-C201
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Enzychem Lifesciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 May 2020 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 5 Aug 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.
Prevention of COVID-19 infection to severe pneumonea or ARDS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EC-18 Arm | Experimental | Drug: EC-18EC-18 QD |
| Placebo Arm | Placebo comparator | Drug: Placebo EC-18Placebo EC-18 QD |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Male or female age 19 years or older
- Pathologically confirmed diagnosis of COVID-19 Infection to Pneumonia
Key exclusion criteria (5 listed)
- Pathologically confirmed diagnosis of bacterial pneumonia or viral pneumonia
- Pregnant or nursing at the time of signing informed consent
- Known sensitivity to any study medication
- Unwilling or unable to complete study diary
- Any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocol
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 |
|---|---|---|
| EC-18EC-18 QD | Drug | EC-18 Arm |
| Placebo EC-18Placebo EC-18 QD | Drug | Placebo Arm |
Primary outcome
Rate of transition to ARDS
Time frame: 14 days after starting IP administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Hyewon Jeong principal investigator
Chungbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EC-18 in people with COVID-19, run by Enzychem Lifesciences Corporation at 1 site in South Korea.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of transition to ARDS (time frame: 14 days after starting IP administration). 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 10 Feb 2022.