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| Column | Value |
|---|---|
| Trial registration number | NCT04582318 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
ngm621@ngmbio.com |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-10-09 |
|
Recruitment status
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
Terminated |
|
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 |
Sequential assignment |
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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 |
single-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - female subjects of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result prior to dosing. - female subjects of childbearing potential and male subjects with a female partner of childbearing potential must use an effective method of contraception during the study, for at least 1 month following study completion, and must not plan to become pregnant for at least 1 month after her last study medication dose. - bmi 18-32 kg/m2 inclusive - ability to understand and provide informed consent - subjects confirmed with sars-cov-2 infection by pcr and hospitalized - if on mechanical support, less or equal than 2 days on mechanical ventilation or oxygenation |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- currently enrolled in another investigational protocol to treat sars-cov-2 infection - known history of complement deficiency - active infection with, or history of, compllicated pneumococcal or neisseria meningitis infection or history of unexplained, recurrent infection, within the last 60 days prior to dosing. |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
5 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
NGM Biopharmaceuticals, Inc |
|
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 |
70 |
|
Countries
Last imported at : Nov. 25, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Australia |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
|
Total sample size
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
16 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment emergent adverse events - Part 2;Treatment emergent adverse events - Part 1;Clinical status at Day 15 and Day 29 - Part 2 |
|
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 1/Phase 2 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 882, "treatment_name": "Ngm621", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 882, "treatment_name": "Ngm621", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 882, "treatment_name": "Ngm621", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 882, "treatment_name": "Ngm621", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |