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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04644120 |
|
Full text link
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
abbvieclinicaltrials@abbvie.com |
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Registration date
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2020-11-25 |
|
Recruitment status
Last imported at : Sept. 2, 2021, 9 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Sequential assignment |
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Masking
Last imported at : Nov. 27, 2020, 12:31 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 : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : March 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - confirmed sars-cov-2 infection based on initial nucleic acid or antigen testing from respiratory swab, saliva, or other bodily fluid within 7 days prior to randomization. - must have >= 1 symptom associated with covid-19 with an onset of <= 8 days prior to randomization. - hospitalized or plans for hospital admission due to covid-19 at the time of randomization or not currently hospitalized and does not have plans for hospital admission at the time of randomization, but is willing to be confined for ≥ 48 hours post-dose for the purposes of participating in this research study |
|
Exclusion criteria
Last imported at : March 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- have an oxygen saturation (spo2) < 88% on room air at rest for 5 minutes or ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) <= 200 mmhg at randomization. - requiring high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/extracorporeal membrane oxygenation (ecmo) or anticipated impending need for high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/ecmo. - prior treatment with a sars-cov-2 specific monoclonal antibody or convalescent covid-19 plasma. |
|
Number of arms
Last imported at : March 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
8 |
|
Funding
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
AbbVie |
|
Inclusion age min
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : March 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Hungary;Israel;Netherlands;Puerto Rico;United States |
|
Type of patients
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : Sept. 2, 2021, 9 p.m. Source : ClinicalTrials.gov |
25 |
|
primary outcome
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions;Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs) |
|
Notes
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 1 |
|
Arms
Last imported at : March 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 8, "treatment_name": "Abbv-47d11", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 8, "treatment_name": "Abbv-47d11", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 8, "treatment_name": "Abbv-47d11", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1873, "treatment_name": "Abbv-2b04", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1874, "treatment_name": "Abbv-2b04+abbv-47d11", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1873, "treatment_name": "Abbv-2b04", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1874, "treatment_name": "Abbv-2b04+abbv-47d11", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |