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Efficacy and Safety Study of Nangibotide in Patients With COVID-19 Receiving Ventilatory Support (ESSENTIAL)

Primary Purpose

COVID19

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
nangibotide
placebo
Sponsored by
Inotrem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provided informed consent (emergency consent according to local regulations where approved)
  2. Age 18 to 75 years (inclusive)
  3. Admitted to an intensive care unit
  4. Treatment with High Flow Nasal Oxygen, non-invasive ventilation or invasive mechanical ventilation for acute respiratory failure caused by COVID-19 for less than 48 hours
  5. A PaO2:FiO2 ratio of <200mmHg (<26.7kPa) with a FiO2 ≥0.6
  6. Confirmed laboratory diagnosis of COVID-19 within 7 days of meeting screening criteria

Exclusion Criteria:

  1. Known pregnancy (positive urine or serum pregnancy test)
  2. Currently receiving an immunomodulatory agent for the treatment of COVID-19 (including participation in clinical trials of such agents where treatment allocation is blinded or allocated on an open label basis).
  3. Body mass index (BMI) ≥ 40 kg/m2or weight ≥ 130 kg
  4. Anticipated transfer to another hospital, which is not a study site within 72 hours
  5. Expected to die within 6 months of treatment due to underlying chronic disease

  6. Limitations of care in place during current hospital admission

    -

Sites / Locations

  • Clinique universitaire Saint-Luc
  • Ziekenhuis Oost-Limburg
  • CHU Angers
  • Centre hospitalier Victor Dupouy
  • Centre Hospitalier Germont et Gauthier
  • CHU Dijon - Bourgogne - Hôpital François Mitterrand
  • CHD Site la Roche sur Yon, les Oudairies
  • Centre hospitalier le Manas
  • Centre Hospitalier Universitaire Dupuytren
  • Centre hospitalier de Melun
  • Hôpital Saint Eloi CHU Montpellier
  • Réanimation Médicale, Hôpital Central
  • Hôpital Dieu - CHU Nanates
  • Hôpital Cochin
  • Hôpital Civil - Nouvel Hôpital civil
  • CHRU - Hôpital Bretonneau
  • Hôpital Franch-Comté Site Trevenans

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

nangibotide

placebo

Arm Description

Continuous infusion of experimental agent for up to 120 hours

Continuous infusion of matched placebo for up to 120 hours

Outcomes

Primary Outcome Measures

Incidence of adverse events until day 28
Part 1
Clinical Status (7-point Ordinal Scale) assessed at Day 28
Part 2

Secondary Outcome Measures

Full Information

First Posted
May 29, 2020
Last Updated
May 2, 2023
Sponsor
Inotrem
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1. Study Identification

Unique Protocol Identification Number
NCT04429334
Brief Title
Efficacy and Safety Study of Nangibotide in Patients With COVID-19 Receiving Ventilatory Support
Acronym
ESSENTIAL
Official Title
Efficacy and Safety Study Exploring Nangibotide Treatment in COVID-19 pAtients With ventiLatory Support (ESSENTIAL) A Randomized, Double-blind, Placebo-controlled Study With Adaptive Features
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
June 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inotrem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled, in which one dose of nangibotide will be tested versus placebo. All patients with a diagnosis of COVID-19, and a requirement for respiratory support will be considered for study participation. The applicable local requirements for informed consent will be followed. Where permissible, an emergency consent procedure will be followed for patients unable to provide consent by themselves. All potential study patients will receive standard of care treatment throughout the study. Patients will receive a continuous intravenous (i.v.) infusion of nangibotide at 1.0 mg/kg/h or a matching placebo. Treatment with study drug must be initiated as early as possible but no later than 48 hours after the initiation of ventilatory support (Patients will be treated for 5 days or until discharge from critical care, whichever is sooner). Follow-up visits will be performed on days 8 and 14. The end of study visit is at day 28. A further follow up visit will be undertaken on day 60.
Detailed Description
ESSENTIAL was a randomized, double-blind, placebo-controlled trial, in which one dose of nangibotide was tested versus placebo. It took place in 14 sites in France and Belgium. The study was overseen by an independent Data Monitoring Committee (DMC). The study was divided into two parts running sequentially without unblinding. Part 1 evaluated safety and tolerability study and included 60 patients, randomized in a 2:1 ratio of nangibotide to placebo. Part 2 included all recruited patients with an initially planned sample size of 370 patients, randomized in a 1:1 ratio of nangibotide to placebo. All patients or their legally authorised representatives provided written informed consent or, in relevant countries, an independent physician, confirmed patient eligibility for enrolment in the trial. Patients received a continuous intravenous infusion of nangibotide at 1.0 mg/kg/h or a matching placebo for 5 days (or until discharge from ICU, whichever was sooner). The treatment was in addition to standard of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nangibotide
Arm Type
Experimental
Arm Description
Continuous infusion of experimental agent for up to 120 hours
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Continuous infusion of matched placebo for up to 120 hours
Intervention Type
Drug
Intervention Name(s)
nangibotide
Intervention Description
nangibotide 1.0 mg/kg/h
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Incidence of adverse events until day 28
Description
Part 1
Time Frame
28 days
Title
Clinical Status (7-point Ordinal Scale) assessed at Day 28
Description
Part 2
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provided informed consent (emergency consent according to local regulations where approved) Age 18 to 75 years (inclusive) Admitted to an intensive care unit Treatment with High Flow Nasal Oxygen, non-invasive ventilation or invasive mechanical ventilation for acute respiratory failure caused by COVID-19 for less than 48 hours A PaO2:FiO2 ratio of <200mmHg (<26.7kPa) with a FiO2 ≥0.6 Confirmed laboratory diagnosis of COVID-19 within 7 days of meeting screening criteria Exclusion Criteria: Known pregnancy (positive urine or serum pregnancy test) Ongoing treatment with an immunomodulatory agent not included in the standard of care for COVID-19 (including participation in clinical trials of such agents)". Body mass index (BMI) ≥ 40 kg/m2or weight ≥ 130 kg Anticipated transfer to another hospital, which is not a study site within 72 hours Expected to die within 6 months of treatment due to underlying chronic disease Limitations of care in place during current hospital admission -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Garaud, MD
Organizational Affiliation
INOTREM SA
Official's Role
Study Chair
Facility Information:
Facility Name
Clinique universitaire Saint-Luc
City
Brussels
ZIP/Postal Code
B-1200
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre hospitalier Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Centre Hospitalier Germont et Gauthier
City
Bethune
ZIP/Postal Code
62400
Country
France
Facility Name
CHU Dijon - Bourgogne - Hôpital François Mitterrand
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHD Site la Roche sur Yon, les Oudairies
City
La Roche sur Yon
ZIP/Postal Code
85 925
Country
France
Facility Name
Centre hospitalier le Manas
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Centre Hospitalier Universitaire Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre hospitalier de Melun
City
Melun
ZIP/Postal Code
77000
Country
France
Facility Name
Hôpital Saint Eloi CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Réanimation Médicale, Hôpital Central
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Hôpital Dieu - CHU Nanates
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Civil - Nouvel Hôpital civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHRU - Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Hôpital Franch-Comté Site Trevenans
City
Trevenans
ZIP/Postal Code
90400
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety Study of Nangibotide in Patients With COVID-19 Receiving Ventilatory Support

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