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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05074433 |
|
Full text link
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Feb. 24, 2022, 6:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Feb. 24, 2022, 6:30 p.m. Source : ClinicalTrials.gov |
clinicaltrials@regeneron.com |
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Registration date
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
2021-10-12 |
|
Recruitment status
Last imported at : July 30, 2022, 4 p.m. Source : ClinicalTrials.gov |
Terminated |
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Study design
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
Sequential assignment |
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Masking
Last imported at : Oct. 14, 2021, 2:24 p.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 : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Feb. 24, 2022, 6:30 p.m. Source : ClinicalTrials.gov |
key inclusion criteria: meets ≥1 of the following criteria: is immunocompromised, including people with transplant, who have cancer, primary immunodeficiencies, hiv, rheumatological disease, autoimmune disease, multiple sclerosis or currently taking immunosuppressant drugs have been fully vaccinated against covid-19 or deemed medically ineligible to receive full course of vaccine has documented negative serology/antibody response in an anti-sars-cov-2 spike protein igg clinical test or ≤50 u/ml on the elecsys® sars-cov-2 s total ig test tested negative for the covid-19 virus within 72 hours prior to randomization key |
|
Exclusion criteria
Last imported at : Feb. 24, 2022, 6:30 p.m. Source : ClinicalTrials.gov |
weighs <40 kg (only applies to participants ≥12 to <18 years of age) has any signs or symptoms consistent with covid-19 past covid-19 infection within 90 days prior to randomization planned use of any investigational, authorized, or approved vaccine for covid-19 within 90 days of the last dose of study drug prior, current, or planned use of any of covid-19 convalescent plasma, other monoclonal antibodies against sars-cov-2 or any covid-19 treatment is planned to begin immunoglobulin (ivig) or immunoglobulin (scig) therapy, is planned to have a change to existing ivig or scig, or has been on a chronic stable dose of their ivig or scig regimen for less than 90 days prior to screening has any known active acute respiratory infection has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection has known allergy or hypersensitivity to components of the study drugs note: other protocol defined inclusion/exclusion criteria apply |
|
Number of arms
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
4 |
|
Funding
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
Regeneron Pharmaceuticals |
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Inclusion age min
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
12 |
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Inclusion age max
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Nov. 4, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
Mexico;United States |
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Type of patients
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
High risk patients |
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Severity scale
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Feb. 24, 2022, 6:30 p.m. Source : ClinicalTrials.gov |
66 |
|
primary outcome
Last imported at : July 26, 2023, midnight Source : ClinicalTrials.gov |
Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP |
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Notes
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Oct. 14, 2021, 2:24 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "initial SC dose + Q4W", "treatment_id": 1864, "treatment_name": "Casirivimab+imdevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "SC dose Q4W", "treatment_id": 1864, "treatment_name": "Casirivimab+imdevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "SC dose Q12W", "treatment_id": 1864, "treatment_name": "Casirivimab+imdevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |