NCT04429334: ESSENTIAL

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

Completed Phase 2 Last updated 3 May 2023

What this trial tests

Phase 2 trial testing nangibotide in COVID19 in 220 participants. Completed in 22 June 2022.

Timeline

23 September 2020

Primary endpoint
20 May 2022

22 June 2022

Quick facts

Lead sponsor	Inotrem
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	220
Start date	23 September 2020
Primary completion	20 May 2022
Estimated completion	22 June 2022
Sites	17 locations across Belgium, France

Drugs / interventions tested

• nangibotide — full drug profile →
• placebo

Conditions studied

• COVID19 — all drugs for COVID19 →

Sponsor

Inotrem — full company profile →

Who can join

Adults 18 to 75, any sex, with COVID19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The biology of TREM receptors.
   Colonna M. · · 2023 · cited 285× · PMID 36750615 · DOI 10.1038/s41577-023-00837-1
2. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
3. 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.
   François B, Lambden S, Garaud JJ, Derive M, et al · · 2023 · cited 11× · PMID 37350989 · DOI 10.1016/j.eclinm.2023.102013
4. Soluble TREM-1 plasma concentration predicts poor outcome in COVID-19 patients.
   Gibot S, Lafon T, Jacquin L, Lefevre B, et al · · 2023 · cited 4× · PMID 37574520 · DOI 10.1186/s40635-023-00532-4