Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock (ASTONISH)
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|ClinicalTrials.gov Identifier: NCT04055909|
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : June 30, 2021
This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.
All patients with a diagnosis of septic shock will be considered for study participation. All potential study patients will receive standard of care for the treatment of septic shock.
After screening for eligibility, patients meeting all inclusion and no exclusion criterion will be randomized. Patients will be randomized to one of three treatment arms.
Treatment with study drug must be initiated as early as possible, but no later than 24 hours after the onset of septic shock, defined by the start of vasopressor therapy.
Patients will be treated for at least 3 days with study drug. After the first 3 days of treatment, patients still requiring vasopressor will be treated until 24 hours after vasopressor withdrawal with a maximum treatment duration of 5 days.
Patients will be assessed at the End of Study (EoS) visit at day 28. After the last patient's day 28 visit, the study will be analyzed. Additional follow up (FU) visits will be conducted after 90 days, 6 and 12 months.
The objective of the study ist to compare the safety, tolerability and efficacy of two doses of nangibotide versus placebo, when given in addition to standard of care.
|Condition or disease||Intervention/treatment||Phase|
|Shock, Septic||Drug: nangibotide low dose Drug: nangibotide high dose Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock. A Randomized, Double-blind, Placebo Controlled Dose Selection Study|
|Actual Study Start Date :||November 13, 2019|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||March 2022|
|Experimental: nangibotide 1||
Drug: nangibotide low dose
nangibotide 0.3 mg/kg/h
|Experimental: nangibotide 2||
Drug: nangibotide high dose
nangibotide 1.0 mg/kg/h
|Placebo Comparator: Placebo||
- Sequential organ failure assessment (SOFA) score [ Time Frame: day 5 ]Change of total SOFA score from baseline to day 5 (in the subgroup defined by patients with elevated sTREM-1 baseline levels and in the overall population)
- All-cause mortality [ Time Frame: day 28 ]Survival and all-cause mortality on D28
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): NCT04055909
|Contact: Jean-Jacques Garaud, MD||+33 (0)9 66 81 79 firstname.lastname@example.org|
|Study Director:||Jean-Jacques Garaud, MD||CEO and Medical Officer|