Clincosm LogoSign in Get a demo

ESSENTIAL: Efficacy and Safety Study of Nangibotide in Patients With COVID-19 Receiving Ventilatory Support and Features of Systemic Inflammation.

Sponsor
Inotrem (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04429334
Collaborator
(none)
730
Enrollment
17
Locations
2
Arms
32.2
Anticipated Duration (Months)
42.9
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
730 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 23, 2020
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: nangibotide

Drug: nangibotide
nangibotide 1.0 mg/kg/h
Placebo Comparator: placebo

Drug: placebo
matching placebo

Outcome Measures

Primary Outcome Measures

  1. Part 1: [28 days]

    Incidence of adverse events until day 28

  2. Part 2: [28 days]

    Clinical Status (7-point Ordinal Scale) assessed at Day 28

  3. Part 3: [28 days]

    All-Cause mortality at day 28

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique universitaire Saint-Luc Brussels Belgium B-1200
2 Ziekenhuis Oost-Limburg Genk Belgium 3600
3 CHU Angers Angers France 49933
4 Centre hospitalier Victor Dupouy Argenteuil France 95107
5 Centre Hospitalier Germont et Gauthier Bethune France 62400
6 CHU Dijon - Bourgogne - Hôpital François Mitterrand Dijon France 21079
7 CHD Site la Roche sur Yon, les Oudairies La Roche sur Yon France 85 925
8 Centre hospitalier le Manas Le Mans France 72037
9 Centre Hospitalier Universitaire Dupuytren Limoges France 87042
10 Centre hospitalier de Melun Melun France 77000
11 Hôpital Saint Eloi CHU Montpellier Montpellier France 34295
12 Réanimation Médicale, Hôpital Central Nancy France 54000
13 Hôpital Dieu - CHU Nanates Nantes France 44093
14 Hôpital Cochin Paris France 75014
15 Hôpital Civil - Nouvel Hôpital civil Strasbourg France 67091
16 CHRU - Hôpital Bretonneau Tours France 37044
17 Hôpital Franch-Comté Site Trevenans Trevenans France 90400

Sponsors and Collaborators

  • Inotrem

Investigators

  • Study Chair: Jean-Jacques Garaud, MD, INOTREM SA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Inotrem
ClinicalTrials.gov Identifier:
NCT04429334
Other Study ID Numbers:
  • MOT-C-204
First Posted:
Jun 12, 2020
Last Update Posted:
Jul 9, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Nangibotide

Study Results

No Results Posted as of Jul 9, 2021