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Insufficient study defined patient population
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Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDP1815 | Experimental | Patients will receive EDP1815 in addition to standard of care |
|
| Placebo | Placebo Comparator | Patients will receive placebo in addition to standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP1815 | Drug | EDP1815 is an orally administered monoclonal microbe |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
| Percentage Change in S/F Ratio |
Not provided
Key Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Reynold Panettieri, MD | Rutgers, The State University of New Jersey | Principal Investigator |
| Douglas Maslin, MD | Evelo Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States | ||
| The University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule |
| FG001 | EDP1815 | Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule |
| BG001 | EDP1815 | Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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] | Posted | Mean | Standard Deviation | Ratio | 14 days |
|
Adverse Events (AE) and Serious Adverse Events (SAE) were documented from the point of informed consent up until 28 days post last administration of Investigational Medicinal Product (IMP), a maximum of up to 42 days post first administration of IMP.
AEs were reported by the participant. Due to the nature of the patient population and disease, only SAEs and AEs of severe (CTCAE Grade 3) and potentially life threatening (CTCAE Grade 4) intensity were documented in the Case Report Form (CRF). AEs of mild (CTCAE Grade 1) or moderate (CTCAE Grade 2) intensity were documented in the medical notes. Adverse events relating to nausea, vomiting, diarrhoea, bloating and abdominal pain of any grade were recorded and assessed as an adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Duncan McHale, MBBS, MRCP, PhD | Evelo Biosciences Inc | +447500128938 | duncan@evelobio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2020 | Jul 22, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 11, 2022 | Jul 22, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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).
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Fully blinded to the participants, investigator, and sponsor
| Placebo |
| Drug |
Placebo oral capsule |
|
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.
| 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) | 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) | 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) | 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) | 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). | 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) | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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 | 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 | 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 | 42 days |
| Newark |
| New Jersey |
| 07103 |
| United States |
| DHR Health Institute | Edinburg | Texas | 78539 | United States |
| Hacettepe University Adult Hospital | Ankara | Turkey (Türkiye) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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. | All participants providing data at the relevant timepoints. | Posted | Mean | Full Range | Ratio | 14 days |
|
|
|
| Secondary | 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. | All participants providing data at the relevant timepoints. | Posted | Mean | Full Range | percentage change | 14 days |
|
|
|
| Secondary | 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) | All participants providing data at the relevant timepoints. | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | 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) | All participants providing data at the relevant timepoints. | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | 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) | All participants providing data at the relevant timepoints. | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | 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). | All participants providing data at the relevant timepoints. | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | days | 42 days |
|
|
|
| Secondary | 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 | All participants providing data within the relevant interval. | Posted | Mean | Standard Deviation | Days | 42 days |
|
|
|
| Secondary | 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 | All participants providing data within the relevant interval. | Posted | Mean | Standard Deviation | degress c | 42 days |
|
|
|
| Secondary | 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 | All participants providing data within the relevant interval. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | 42 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | 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 | The numbers analyzed only includes those participants who experienced adverse events. | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | 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 | Any clinically significant abnormal lab parameters were included as AEs. | Posted | Number | number of participants | 42 days |
|
|
|
| Secondary | 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 | Only serious AEs, AEs of CTCAE Grade 3 or above and AEs of special interest (all CTCAE grades) were documented and included in the summary. | Posted | Count of Participants | Participants | 42 days |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | EDP1815 | Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe | 0 | 9 | 1 | 9 | 4 | 9 |
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Day 7 |
|
|
| Day 10 |
|
|
| Day 14 |
|
|
| Day 7 |
|
|
| Day 10 |
|
|
| Day 14 |
|
|
| WHO OSCI score - 1 |
|
| WHO OSCI score - 2 |
|
| WHO OSCI score - 3 |
|
| WHO OSCI score - 4 |
|
| WHO OSCI score - 5 |
|
| WHO OSCI score - 6 |
|
| WHO OSCI score - 7 |
|
| WHO OSCI score - 8 |
|
| Day 7 |
|
|
| Day 14 |
|
|
| Day 21 |
|
|
| Day 42 |
|
|
| Baseline WHO OSCI score 4; WHO OSCI Score - 1 |
|
| Baseline WHO OSCI score 4; WHO OSCI Score - 2 |
|
| Baseline WHO OSCI score 4; WHO OSCI Score - 3 |
|
| Baseline WHO OSCI score 4; WHO OSCI Score - 4 |
|
| Baseline WHO OSCI score 4; WHO OSCI Score - 5 |
|
| Baseline WHO OSCI score 4; WHO OSCI Score - 6 |
|
| Baseline WHO OSCI score 4; WHO OSCI Score - 7 |
|
| Baseline WHO OSCI score 4; WHO OSCI Score - 8 |
|
| Baseline WHO OSCI score 5; WHO OSCI Score - 0 |
|
| Baseline WHO OSCI score 5; WHO OSCI Score - 1 |
|
| Baseline WHO OSCI score 5; WHO OSCI Score - 2 |
|
| Baseline WHO OSCI score 5; WHO OSCI Score - 3 |
|
| Baseline WHO OSCI score 5; WHO OSCI Score - 4 |
|
| Baseline WHO OSCI score 5; WHO OSCI Score - 5 |
|
| Baseline WHO OSCI score 5; WHO OSCI Score - 6 |
|
| Baseline WHO OSCI score 5; WHO OSCI Score - 7 |
|
| Baseline WHO OSCI score 5; WHO OSCI Score - 8 |
|
| Day7 |
|
|
| Day 14 |
|
|
| Day 21 |
|
|
| Day 42 |
|
|
| Day 7 |
|
|
| Day 14 |
|
|
| Day 21 |
|
|
| Day 42 |
|
|
| Score = 5 |
|
| Score = 6 |
|
| Score = 7 |
|
| Score = 8 |
|
| Score = 3; 4-7 days |
|
| Score = 3; >7 days |
|
| Score = 4; 1 day |
|
| Score = 4; 2-3 days |
|
| Score = 4; 4-7 days |
|
| Score = 4; >7 days |
|
| Score = 5: 1 day |
|
| Score = 5; 2-3 days |
|
| Score = 5; 4-7 days |
|
| Score = 5; >7days |
|
| Score = 6; 1 days |
|
| Score = 6; 2-3 days |
|
| Score = 6; 4-7 days |
|
| Score = 6; >7 days |
|
| Score = 7 |
|
| Score = 8 |
|
| Days 1-42 |
|
| Days 1-42 |
|
| Days 1-42 |
|
| Days 1-14 (min) |
|
| Days 1-14 (max) |
|
| Days 1-28 (min) |
|
| Days 1-28 (max) |
|
| Days 1-42 (min) |
|
| Days 1-42 (max) |
|
| Number of participants censored |
|
| Number of participants censored |
|
| Number of participants censored |
|
| Diarrhoea : Not related |
|
| Diarrhoea : Related |
|
| Abdominal distension : Not related |
|
| Abdominal distension : Related |
|
| Hypertension : Not related |
|
| Hypertension : Related |
|
| Abdominal distension |
|
| Hypertension |
|