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Trial - NCT04429334


Column Value
Trial registration number NCT04429334
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04429334

First author
Last imported at : Jan. 21, 2023, noon
Source : ClinicalTrials.gov

Jean-Jacques Garaud

Contact
Last imported at : Jan. 21, 2023, noon
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-06-12

Recruitment status
Last imported at : Jan. 21, 2023, noon
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: 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 criteria
Last imported at : May 4, 2023, 8 p.m.
Source : ClinicalTrials.gov

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 -

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Inotrem

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

75

Countries
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov

Belgium;France

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

8: Critical disease at enrollment

Total sample size
Last imported at : Jan. 21, 2023, noon
Source : ClinicalTrials.gov

220

primary outcome
Last imported at : Jan. 5, 2023, 4 p.m.
Source : ClinicalTrials.gov

Clinical Status (7-point Ordinal Scale) assessed at Day 28;Incidence of adverse events until day 28

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Jan. 5, 2023, 4 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 856, "treatment_name": "Nangibotide", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]