Status:
COMPLETED
Efficacy and Safety Study of Nangibotide in Patients With COVID-19 Receiving Ventilatory Support
Lead Sponsor:
Inotrem
Conditions:
COVID19
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 su...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- \-
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2022
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04429334
Start Date
September 23 2020
End Date
June 22 2022
Last Update
May 3 2023
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinique universitaire Saint-Luc
Brussels, Belgium, B-1200
2
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
3
CHU Angers
Angers, France, 49933
4
Centre hospitalier Victor Dupouy
Argenteuil, France, 95107