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| Column | Value |
|---|---|
| Trial registration number | NCT04941183 |
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Full text link
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
christa.firbas@meduniwien.ac.at |
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Registration date
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
2021-06-28 |
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Recruitment status
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Sequential assignment |
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Masking
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
healthy volunteers: inclusion criteria: - male or female, non-smoker, ≥18 and ≤55 years of age, with body mass index (bmi) > 18.5 and < 32.0 kg/m2 - healthy with no clinically significant findings, determined by medical evaluation (medical history, physical examination, vital signs, 12-lead ecg, and clinical laboratory evaluations) at screening - subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff. - subject voluntarily agrees to participate in this study. |
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Exclusion criteria
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
- pregnancy, nursing, and/or breastfeeding. - study participant has a history of an anaphylactic reaction. - subject has used an investigational drug within 30 days (or 5 half-lives whichever is longer) prior to the first dose of study drug. - has received any prescription or nonprescription over-the-counter (except occasional use of acetaminophen, paracetamol or ibuprofen) medication, topical medications, vitamins, dietary or herbal during the last 14 days or 5 half-lives, whichever is longer. - subject has a positive urine test for drugs of abuse at the screening visit or admission. - regular consumption of alcohol within 6 months prior to screening or use of illicit substances within 3 months prior to screening. - subject has positive test for sars-cov-2 infection, human immunodeficiency virus (hiv), chronic or active hepatitis b, or active hepatitis c. - donation or loss of blood or plasma within 4 weeks prior to initial dosing. - subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, mental or other medical disorder, including cirrhosis or malignancy; a history of a psychiatric disorder that will affect the subject's ability to participate in the study. - subject has a clinically relevant abnormal ecg; abnormal laboratory values. - subject has hypertension. covid-19 patients: inclusion criteria: - male or female, non-smoker, ≥18 years of age. - participant has active laboratory-confirmed sars-cov-2 infection. - participant must be hospitalized for covid-19 pneumonia. - ability to provide informed consent personally, or by a legally acceptable representative if the participant is unable to do so. |
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Number of arms
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Neutrolis |
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Inclusion age min
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
99 |
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Countries
Last imported at : Jan. 20, 2022, 11:30 a.m. Source : ClinicalTrials.gov |
Austria;Ukraine |
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Type of patients
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Moderate/severe/critical disease at enrollment |
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Severity scale
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
5: Moderate/severe/critical disease at enrollment |
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Total sample size
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
92 |
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primary outcome
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
To evaluate safety and tolerability of single and multiple ascending doses of NTR-441 solution administered intravenously (IV) to adults |
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Notes
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Phase 1 |
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Arms
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 913, "treatment_name": "Ntr-441", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 913, "treatment_name": "Ntr-441", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |