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

NCT04429334 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: MOT-C-204
• Study Type: interventional
• Target: 220
• Locations: 2 countries
• Sites: 17

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.

Conditions

COVID19

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events until day 28

  Part 1

  28 days

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

  Part 2

  28 days

Study Arms (2)

nangibotide

EXPERIMENTAL

Continuous infusion of experimental agent for up to 120 hours

Drug: nangibotide

placebo

PLACEBO COMPARATOR

Continuous infusion of matched placebo for up to 120 hours

Drug: placebo

Interventions

nangibotide DRUG

nangibotide 1.0 mg/kg/h

nangibotide

placebo DRUG

matching placebo

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inotrem: lead

Study Sites (17)

Clinique universitaire Saint-Luc

Brussels, B-1200, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

CHU Angers

Angers, 49933, France

Location

Centre hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Centre Hospitalier Germont et Gauthier

Béthune, 62400, France

Location

CHU Dijon - Bourgogne - Hôpital François Mitterrand

Dijon, 21079, France

Location

CHD Site la Roche sur Yon, les Oudairies

La Roche-sur-Yon, 85 925, France

Location

Centre hospitalier le Manas

Le Mans, 72037, France

Location

Centre Hospitalier Universitaire Dupuytren

Limoges, 87042, France

Location

Centre hospitalier de Melun

Melun, 77000, France

Location

Hôpital Saint Eloi CHU Montpellier

Montpellier, 34295, France

Location

Réanimation Médicale, Hôpital Central

Nancy, 54000, France

Location

Hôpital Dieu - CHU Nanates

Nantes, 44093, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Civil - Nouvel Hôpital civil

Strasbourg, 67091, France

Location

CHRU - Hôpital Bretonneau

Tours, 37044, France

Location

Hôpital Franch-Comté Site Trevenans

Trévenans, 90400, France

Location

Related Publications (1)

• Francois B, Lambden S, Garaud JJ, Derive M, Grouin JM, Asfar P, Darreau C, Mira JP, Quenot JP, Lemarie J, Mercier E, Lacherade JC, Vinsonneau C, Fivez T, Helms J, Badie J, Levy M, Cuvier V, Salcedo-Magguilli M, Laszlo-Pouvreau AL, Laterre PF, Gibot S; ESSENTIAL investigators. Evaluation of the efficacy and safety of TREM-1 inhibition with nangibotide in patients with COVID-19 receiving respiratory support: the ESSENTIAL randomised, double-blind trial. EClinicalMedicine. 2023 Jun;60:102013. doi: 10.1016/j.eclinm.2023.102013. Epub 2023 May 31.

  PMID: 37350989 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

nangibotide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Jacques Garaud, MD

  INOTREM SA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 12, 2020
• Study Start: September 23, 2020
• Primary Completion: May 20, 2022
• Study Completion: June 22, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15); BE (2)