Covid19Phase 2NCT04488575
Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection
A Phase 2 study testing EDP1815 in people with Covid19, run by Evelo Biosciences, Inc. at 4 sites in 2 countries.
Trial summary
Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- EDP1815
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 26 Aug 2020to 19 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Hospitalized within the last 36 hours.
- Receiving any form of supplementary oxygen therapy at baseline.
- Confirmed COVID-19 viral infection by RTPCR at screening.
- Age:
- 18-65 years old, OR
- >65 year-olds can be included after Data Monitoring Committee (DMC) approval
Who cannot join
- Contraindications/hypersensitivity to P histicola or any of the capsule excipients
- Patients with chronic hypoxia or underlying significant chronic respiratory disease (such as Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Fibrosis, or Bronchiectasis).
- Admission to ICU at time of screening.
- Mechanically ventilated, on continuous positive airway pressure (CPAP), or on non-invasive ventilation at the time of screening.
- Patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin, or tacrolimus, unless these are given as part of COVID standard of care treatment.
- Patient has a diagnosed primary immunodeficiency.
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- Patient has a diagnosis of HIV/AIDS
- Patient has pre-existing known chronic kidney disease stage 4 or 5 or requiring renal replacement therapy (i.e. estimated glomerular filtration rate (eGFR) <30ml/min/1.73m2)
- Patient has pre-existing known significant liver disease with Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5.0 x upper limit of normal (ULN)
- Patient has pre-existing known significant gastrointestinal tract disease expected to affect absorption within the small intestine (e.g. short bowel syndrome, inflammatory bowel disease affecting the small intestine, gastroparesis); or prior malabsorptive bariatric surgery that could interfere with GI delivery and transit time.
- GI signs or symptoms equivalent to CTCAE v5.0, gastrointestinal disorders, grade 3 or 4 event.
- Patient has pre-existing known substantially impaired cardiac function or pre-existing clinically significant cardiac diseases, including unstable angina or acute myocardial infarction ≤ 6 weeks prior to Screening.
- Currently participating in an interventional clinical trial (observational studies allowed).
- Moribund at time of screening
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
DHR Health Institute
Edinburg, Texas, 78539
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
The University Hospital
Newark, New Jersey, 07103
About this study
Official title: A Phase 2 Double-blind Placebo-controlled Study Investigating the Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With SARS-CoV-2 Infection
Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection
Read the detailed description
This is a randomized, placebo-controlled clinical study to assess the safety and efficacy of EDP1815 in patients hospitalized with COVID-19 infection.
The study is designed to evaluate the efficacy of EDP1815 at reducing time to resolution of symptoms, preventing progression of COVID-19 symptoms and preventing COVID-Related Complications (CRC)
- Conditions
- Covid19
- Being tested
- EDP1815, Placebo
- Keywords
- SARS-CoV-2, corona virus, coronavirus, corona
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP1815Drug
EDP1815 is an orally administered monoclonal microbe
PlaceboDrug
Placebo oral capsule
| Study group | Role | What they receive |
|---|---|---|
| EDP1815 | Experimental | Patients will receive EDP1815 in addition to standard of care Receives: Drug: EDP1815 |
| Placebo | Placebo comparator | Patients will receive placebo in addition to standard of care Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14
Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]
Measured: 14 days
Secondary outcomes (19)
Change in S/F Ratio
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using change in S/F ratio at days 4, 7, 10 and 14/discharge day.
Measured: 14 days
Percentage Change in S/F Ratio
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage change in S/F ratio at days 4, 7, 10 and 14/discharge day.
Measured: 14 days
Percentage of Participants at Each Level on the WHO OSCI Score
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants at each level on the WHO OSCI score at days 4, 7, 14, 21 and 42.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=unifected - 8=death)
Measured: 42 days
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants with shifts from each level of the WHO OSCI score at baseline at days 4, 7, 14, 21 and 42.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Measured: 42 days
Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants remaining at their baseline score on the WHO OSCI (or lower) at days 4, 7, 14, 21 and 42. Once a participant has increased their WHO OSCI score they are not considered to have remained at or below their baseline value at future visits regardless of whether their score returns to or below their baseline value.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Measured: 42 days
Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Measured: 42 days
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death).
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the time in days spent at each participant's worst reported WHO OSCI score (excluding death).
Measured: 42 days
Intubation and Mechanical-ventilation Free Survival
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the intubation and mechanical-ventilation free survival, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 6 or more.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Measured: 42 days
Overall Survival
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using overall survival, defined as the time in days from start of treatment to death by any cause
Measured: 42 days
Number of Days Requiring Oxygen Therapy
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days requiring oxygen therapy
Measured: 42 days
Number of Days With Pyrexia
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days with pyrexia ≥ 38C
Measured: 42 days
Maximum Daily Temperature
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature
Measured: 42 days
SpO2 Level
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels
Measured: 42 days
Time to Discharge
The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to discharge, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 2 or less.
Measured: 42 days
Time to Oxygen Saturation (SpO2) ≥94%
The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to oxygen saturation (SpO2) ≥94% on room air without further requirement for oxygen therapy.
Measured: 42 days
Time to Recovery
The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to recovery, defined as the time in days from symptom onset to alleviation of all COVID-19 symptoms.
Measured: 42 days
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by relationship to treatment
Measured: 42 days
Incidence of Clinically Significant Abnormal Lab Parameters
The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing clinically significant abnormal changes in safety lab parameters
Measured: 42 days
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start26 Aug 2020
- Primary completion16 May 2021
- Study completion19 May 2021
Why it stopped: Insufficient study defined patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies 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
- Model description
- Patients will be randomized to either the active (EDP1815) or placebo group (1:1 randomization), in addition to standard of care. Dosing will be initiated on a twice daily regime for the first 3 days (6 doses) and then once daily for the remaining 11 days (14 days total treatment course).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evelo Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reynold Panettieri, MD, Principal investigator, Rutgers, The State University of New JerseyDouglas Maslin, MD, Study director, Evelo Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488575
- Sponsor's protocol ID
- EDP1815-205
- Status last verified
- Jul 2022
- First submitted
- 23 Jul 2020
- Last updated
- 19 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Double-blind Placebo-controlled Study Investigating the Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04488575
- Acronym / sponsor ID
- EDP1815-205
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, corona virus, coronavirus, corona
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient study defined patient population
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Evelo Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 16 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Posted 19 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection
Detailed description
This is a randomized, placebo-controlled clinical study to assess the safety and efficacy of EDP1815 in patients hospitalized with COVID-19 infection.
The study is designed to evaluate the efficacy of EDP1815 at reducing time to resolution of symptoms, preventing progression of COVID-19 symptoms and preventing COVID-Related Complications (CRC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to either the active (EDP1815) or placebo group (1:1 randomization), in addition to standard of care. Dosing will be initiated on a twice daily regime for the first 3 days (6 doses) and then once daily for the remaining 11 days (14 days total treatment course).
| Arm | Type | Receives |
|---|---|---|
| EDP1815 | Experimental | Drug: EDP1815Patients will receive EDP1815 in addition to standard of care |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive placebo in addition to standard of care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalized within the last 36 hours.
- Receiving any form of supplementary oxygen therapy at baseline.
- Confirmed COVID-19 viral infection by RTPCR at screening.
- Age:
Key exclusion criteria (14 listed)
- Contraindications/hypersensitivity to P histicola or any of the capsule excipients
- Patients with chronic hypoxia or underlying significant chronic respiratory disease (such as Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Fibrosis, or Bronchiectasis).
- Admission to ICU at time of screening.
- Mechanically ventilated, on continuous positive airway pressure (CPAP), or on non-invasive ventilation at the time of screening.
- Patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin, or tacrolimus, unless these are given as part of COVID standard of care treatment.
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 |
|---|---|---|
| EDP1815EDP1815 is an orally administered monoclonal microbe | Drug | EDP1815 |
| PlaceboPlacebo oral capsule | Drug | Placebo |
Primary outcome
Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14
Time frame: 14 days
Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]
19 secondary outcomes
Change in S/F Ratio
Time frame: 14 days
Percentage Change in S/F Ratio
Time frame: 14 days
Percentage of Participants at Each Level on the WHO OSCI Score
Time frame: 42 days
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline
Time frame: 42 days
Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)
Time frame: 42 days
Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day
Time frame: 42 days
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death).
Time frame: 42 days
Intubation and Mechanical-ventilation Free Survival
Time frame: 42 days
Overall Survival
Time frame: 42 days
Number of Days Requiring Oxygen Therapy
Time frame: 42 days
Number of Days With Pyrexia
Time frame: 42 days
Maximum Daily Temperature
Time frame: 42 days
SpO2 Level
Time frame: 42 days
Time to Discharge
Time frame: 42 days
Time to Oxygen Saturation (SpO2) ≥94%
Time frame: 42 days
Time to Recovery
Time frame: 42 days
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
Time frame: 42 days
Incidence of Clinically Significant Abnormal Lab Parameters
Time frame: 42 days
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Reynold Panettieri, MD principal investigator
Rutgers, The State University of New Jersey
Douglas Maslin, MD study director
Evelo Biosciences
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDP1815 in people with Covid19, run by Evelo Biosciences, Inc. at 4 sites in 2 countries.
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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 19 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14 (time frame: 14 days). 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 19 Dec 2022.