NCT04488575 is a Phase 2 clinical trial of EDP1815 in Covid19, sponsored by Evelo Biosciences, Inc..

Who is sponsoring NCT04488575?

NCT04488575 is sponsored by Evelo Biosciences, Inc..

What drugs are being tested in NCT04488575?

Interventions in NCT04488575: EDP1815, Placebo.

Is NCT04488575 still recruiting?

NCT04488575 is currently terminated. Last updated 19 December 2022.

Are results published for NCT04488575?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-12-19 · How we verify

NCT04488575

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection

Terminated Phase 2 Results posted Last updated 19 December 2022

What this trial tests

Phase 2 trial testing EDP1815 in Covid19 in 16 participants. Terminated before completion.

Timeline

26 August 2020

Primary endpoint
16 May 2021

19 May 2021

Quick facts

Lead sponsor	Evelo Biosciences, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	16
Start date	26 August 2020
Primary completion	16 May 2021
Estimated completion	19 May 2021
Sites	4 locations across United States, Turkey (Türkiye)

Drugs / interventions tested

EDP1815
Placebo

Conditions studied

Covid19 — all drugs for Covid19 →

Sponsor

Evelo Biosciences, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14 Primary · 14 days

Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) \[S/F ratio\]

Group	Value	95% CI
Placebo	-30.0	± 114.95
EDP1815	-63.8	± 76.85

Change in S/F Ratio Secondary · 14 days

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.

Day 4

Group	Value	95% CI
Placebo	37.4	-59.0 – 148.0
EDP1815	-23.0	-188.0 – 167.0

Day 7

Group	Value	95% CI
Placebo	-16.0	-65.0 – 20.0
EDP1815	-86.7	-130.0 – 6.0

Day 10

Group	Value	95% CI
Placebo	37.0	-68.0 – 142.0
EDP1815	-111.0	-115.0 – -107.0

Day 14

Group	Value	95% CI
Placebo	-83.0	-83.0 – -83.0
EDP1815	-14.0	-53.0 – 25.0

Percentage Change in S/F Ratio Secondary · 14 days

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.

Day 4

Group	Value	95% CI
Placebo	10.97	-33.1 – 49.3
EDP1815	-5.33	-66.0 – 104.4

Day 7

Group	Value	95% CI
Placebo	-10.41	-36.5 – 8.4
EDP1815	-36.48	-57.6 – 2.1

Day 10

Group	Value	95% CI
Placebo	109.7	-38.2 – 147.9
EDP1815	-46.6	-48.7 – -44.4

Day 14

Group	Value	95% CI
Placebo	-46.6	-46.6 – -46.6
EDP1815	-5.7	-22.0 – 10.6

Percentage of Participants at Each Level on the WHO OSCI Score Secondary · 42 days

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)

Day 4

Group	Value	95% CI
Placebo	1
EDP1815	0
Placebo	0
EDP1815	0
Placebo	0
EDP1815	1
Placebo	1
EDP1815	1

Day 7

Group	Value	95% CI
Placebo	1
EDP1815	0
Placebo	0
EDP1815	0
Placebo	3
EDP1815	2
Placebo	0
EDP1815	0

Day 14

Group	Value	95% CI
Placebo	3
EDP1815	1
Placebo	0
EDP1815	0
Placebo	2
EDP1815	3
Placebo	0
EDP1815	0

Day 21

Group	Value	95% CI
Placebo	4
EDP1815	1
Placebo	0
EDP1815	0
Placebo	1
EDP1815	4
Placebo	0
EDP1815	0

Day 42

Group	Value	95% CI
Placebo	4
EDP1815	3
Placebo	0
EDP1815	0
Placebo	0
EDP1815	0
Placebo	0
EDP1815	0

Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Secondary · 42 days

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)

Day 4

Group	Value	95% CI
Placebo	1
EDP1815	0
Placebo	0
EDP1815	0
Placebo	0
EDP1815	1
Placebo	1
EDP1815	1

Day7

Group	Value	95% CI
Placebo	1
EDP1815	0
Placebo	0
EDP1815	0
Placebo	3
EDP1815	2
Placebo	0
EDP1815	0

Day 14

Group	Value	95% CI
Placebo	3
EDP1815	1
Placebo	0
EDP1815	0
Placebo	2
EDP1815	3
Placebo	0
EDP1815	0

Day 21

Group	Value	95% CI
Placebo	4
EDP1815	1
Placebo	0
EDP1815	0
Placebo	1
EDP1815	4
Placebo	0
EDP1815	0

Day 42

Group	Value	95% CI
Placebo	4
EDP1815	3
Placebo	0
EDP1815	0
Placebo	0
EDP1815	0
Placebo	0
EDP1815	0

Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) Secondary · 42 days

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)

Day 4

Group	Value	95% CI
Placebo	7
EDP1815	7

Day 7

Group	Value	95% CI
Placebo	6
EDP1815	3

Day 14

Group	Value	95% CI
Placebo	5
EDP1815	4

Day 21

Group	Value	95% CI
Placebo	5
EDP1815	4

Day 42

Group	Value	95% CI
Placebo	4
EDP1815	3

Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day Secondary · 42 days

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)

Group	Value	95% CI
Placebo	1
EDP1815	0
Placebo	4
EDP1815	7
Placebo	2
EDP1815	1
Placebo	0
EDP1815	1

The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Secondary · 42 days

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).

Group	Value	95% CI
Placebo	1
EDP1815	0
Placebo	0
EDP1815	0
Placebo	0
EDP1815	0
Placebo	0
EDP1815	0

Intubation and Mechanical-ventilation Free Survival Secondary · 42 days

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)

Group	Value	95% CI
Placebo	0
EDP1815	1
Placebo	7
EDP1815	8

Overall Survival Secondary · 42 days

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

Group	Value	95% CI
Placebo	0
EDP1815	0
Placebo	7
EDP1815	9

Number of Days Requiring Oxygen Therapy Secondary · 42 days

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

Days 1-14

Group	Value	95% CI
Placebo	6.9	± 5.01
EDP1815	6.8	± 4.52

Days 1-28

Group	Value	95% CI
Placebo	8.9	± 9.30
EDP1815	8.8	± 8.66

Days 1-42

Group	Value	95% CI
Placebo	10.9	± 14.28
EDP1815	9	± 9.22

Number of Days With Pyrexia Secondary · 42 days

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

Days 1-14

Group	Value	95% CI
Placebo	0.1	± 0.38
EDP1815	0.4	± 0.73

Days 1-28

Group	Value	95% CI
Placebo	0.1	± 0.38
EDP1815	0.4	± 0.73

Days 1-42

Group	Value	95% CI
Placebo	0.1	± 0.38
EDP1815	0.4	± 0.73

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/7 (0%)

Deaths: 0/7

EDP1815

Serious: 1/9 (11%)

Deaths: 0/9

Serious adverse events (1 terms)

Reaction	System	Placebo	EDP1815
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Placebo	EDP1815
Hypertension	Vascular disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—

Most-reported serious reactions: Acute respiratory distress syndrome.

Data from ClinicalTrials.gov NCT04488575 adverse events section.

Sponsor's own description

Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of EDP1815

Trials testing the same drug.

NCT05682222 — Evaluation of the Immunopharmacology of EDP1815 and EDP2939 · Phase 1 · completed
NCT05439941 — A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials · Phase 2 · terminated
NCT05121480 — A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis · Phase 2 · completed
NCT04603027 — A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis · Phase 2 · completed
NCT04393246 — mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms · Phase 2, PHASE3 · completed

Other recruiting trials for Covid19

Currently open trials in the same condition.

NCT03305341 — Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix · EARLY_PHASE1 · active not recruiting
NCT06482138 — Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation · NA · recruiting
NCT04924803 — Community Developed Technology-Based Messaging to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs · NA · active not recruiting
NCT05013632 — COVID-19 International Drug Pregnancy Registry · recruiting
NCT04806061 — Urine Alkalinisation in COVID-19 · NA · active not recruiting

Other Evelo Biosciences, Inc. trials

Trials by the same sponsor.

NCT05682222 — Evaluation of the Immunopharmacology of EDP1815 and EDP2939 · Phase 1 · completed
NCT05439941 — A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials · Phase 2 · terminated
NCT05121480 — A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis · Phase 2 · completed
NCT05066373 — Scintigraphy Study to Evaluate the Gastrointestinal Behavior of EDP1815 Oral Dosage Forms · Phase 1 · completed
NCT04927195 — Study in Healthy Participants and Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04488575 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Evelo Biosciences, Inc.
Last refreshed: 19 December 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04488575.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04488575

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of EDP1815

Other recruiting trials for Covid19

Other Evelo Biosciences, Inc. trials

Verify against primary sources