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Safety, Tolerability and Efficacy of Nangibotide in Mechanically Ventilated Patients With COVID-19 and Features of Systemic Inflammation

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429334
Recruitment Status : Not yet recruiting
First Posted : June 12, 2020
Last Update Posted : July 28, 2020
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 coronavirus disease 2019 (COVID-19), and a requirement for invasive mechanical ventilation will be considered for study participation. All study patients will receive standard of care treatment throughout the study. After screening for eligibility, patients will be randomized to one of two treatment arms. 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 invasive mechanical ventilation. Patients will be treated for 5 days or until discharge from critical care, whichever is sooner. The treatment with study drug will be in addition to standard of care. A follow-up visit will be performed on days 8 and 14. The end of study visit is at day 28.


Condition or disease Intervention/treatment Phase
COVID19 Drug: nangibotide Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exploratory Study of the Safety, Tolerability and Efficacy of Nangibotide in Mechanically Ventilated Patients With COVID-19 and Features of Systemic Inflammation A Randomized, Double-blind, Placebo-controlled Study With Adaptive Features
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

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

Placebo Comparator: placebo Drug: placebo
matching placebo




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

  2. Mortality [ Time Frame: 28 days ]
    Incidence of mortality until day 28



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. Invasive mechanical ventilation (respiratory support using a mechanical ventilator delivered via an endotracheal tube or tracheostomy) for acute respiratory failure caused by COVID-19 for less than 48 hours
  4. A PaO2:FiO2 ratio of <200mmHg (<26.7kPa)
  5. 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. Weight > 95 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
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France
Réanimation Médicale, Hôpital Central
Nancy, France, 54000
Contact: Sébastien Gibot, MD         
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 28, 2020
Last Verified: July 2020
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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Inflammation
Pathologic Processes