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

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ClinicalTrials.gov Identifier: NCT04429334
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Inotrem

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
COVID19 Drug: nangibotide Drug: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 23, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
Experimental: nangibotide Drug: nangibotide
nangibotide 1.0 mg/kg/h

Placebo Comparator: placebo Drug: placebo
matching placebo




Primary Outcome Measures :
  1. Part 1: [ Time Frame: 28 days ]
    Incidence of adverse events until day 28

  2. Part 2: [ Time Frame: 28 days ]
    Clinical Status (7-point Ordinal Scale) assessed at Day 28

  3. Part 3: [ Time Frame: 28 days ]
    All-Cause mortality at day 28



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429334


Contacts
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Contact: Jean-Jacques Garaud, MD +33 (0)9 66 81 79 00 covtrem@inotrem.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Inotrem
Investigators
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Study Chair: Jean-Jacques Garaud, MD INOTREM SA
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Responsible Party: Inotrem
ClinicalTrials.gov Identifier: NCT04429334    
Other Study ID Numbers: MOT-C-204
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No