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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429334
Recruitment Status : Completed
First Posted : June 12, 2020
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Inotrem

Study Description
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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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 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
Actual Primary Completion Date : May 20, 2022
Actual Study Completion Date : June 22, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: nangibotide
Continuous infusion of experimental agent for up to 120 hours
 Drug: nangibotide
nangibotide 1.0 mg/kg/h
Placebo Comparator: placebo
Continuous infusion of matched placebo for up to 120 hours
 Drug: placebo
matching placebo


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

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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Ongoing treatment with an immunomodulatory agent not included in the standard of care for COVID-19 (including participation in clinical trials of such agents)".
  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
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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


Locations
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Sponsors and Collaborators
Inotrem
Investigators
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Study Chair: Jean-Jacques Garaud, MD INOTREM SA
More Information
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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: May 3, 2023
Last Verified: May 2023
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
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Nangibotide
Anti-Inflammatory Agents