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| Column | Value |
|---|---|
| Trial registration number | NCT04333420 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
Korinna Pilz, korinna.pilz@inflarx.de (PI email not reported) |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-03 |
|
Recruitment status
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Oct. 26, 2020, 11:31 p.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 : June 6, 2023, 8 a.m. Source : ClinicalTrials.gov |
phase ii inclusion criteria: at least 18 years of age or older clinically evident or otherwise confirmed severe pneumonia sars-cov-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system) |
|
Exclusion criteria
Last imported at : June 6, 2023, 8 a.m. Source : ClinicalTrials.gov |
known history of progressed copd as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for > 2 months patient moribund or expected to die in next 24h according to the judgment of the investigator known severe congestive heart failure (new york heart association [nyha] class iii- iv) received organ or bone marrow transplantation in past 3 months known cardio-pulmonary mechanical resuscitation in past 14 days phase iii: inclusion criteria: at least 18 years of age or older patient on invasive mechanical ventilation (but not more than 48h post intubation at time point of first imp administration) patients with a pao2 / fio2 ratio of < 200 and > 60 at randomization (one representative measurement within 6h before randomization) sars-cov-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system) |
|
Number of arms
Last imported at : June 6, 2023, 8 a.m. Source : ClinicalTrials.gov |
4 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
InflaRx GmbH |
|
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 |
100 |
|
Countries
Last imported at : June 27, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Belgium;Brazil;France;Germany;Mexico;Netherlands;Peru;Russia;South Africa |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
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Total sample size
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
399 |
|
primary outcome
Last imported at : June 6, 2023, 8 a.m. Source : ClinicalTrials.gov |
Phase III: 28-day All-cause Mortality (FAS);Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS) |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : June 6, 2023, 8 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Phase II study part", "treatment_id": 626, "treatment_name": "Vilobelimab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "Phase III study part", "treatment_id": 626, "treatment_name": "Vilobelimab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |