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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005222-14 | EudraCT Number |
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Emerging SARS-CoV2 variants impacting susceptibility to study drug
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The primary objective of the study is to evaluate the effect of casirivimab+imdevimab, compared with placebo, in preventing symptomatic SARS-CoV-2 infection in immunocompromised participants.
The secondary objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| casirivimab+imdevimab Initial + Q4W | Experimental | Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W) |
|
| casirivimab+imdevimab Q4W | Experimental | SC dose Q4W |
|
| casirivimab+imdevimab Q12W | Experimental | SC dose every 12 weeks (Q12W) |
|
| Placebo | Placebo Comparator | SC dose Q4W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| casirivimab+imdevimab | Drug | Co-administered sequentially subcutaneous (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP | Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases during the Efficacy Assessment Period (EAP) | The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the EAP | The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days | |
| Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the Follow-Up Period |
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Key Inclusion Criteria:
Meets ≥1 of the following criteria:
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:
NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Alabama Research | Birmingham | Alabama | 35205 | United States | ||
| Baptist Health Center for Clinical Research |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W) |
| FG001 | Casirivimab+Imdevimab Initial + Q4W | Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2022 | May 16, 2023 |
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|
| Placebo | Drug | Administered SC |
|
| End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months) |
| Number of Participants With TEAEs Leading to Study Drug Discontinuation During the EAP | The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days |
| Number of Participants With TEAEs Leading to Study Drug Discontinuation During the Follow-Up Period | End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months) |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the EAP | The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days |
| Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Follow-Up Period | End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months) |
| Incidence of Adverse Events of Special Interest (AESIs) During the EAP | The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days |
| Concentration of Casirivimab Over Time | Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group |
| Concentration of Imdevimab Over Time | Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group |
| Incidence of Anti-drug Antibodies (ADA) Over Time | Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group |
| Incidence of Neutralizing Antibodies (NAb) to Each mAb Over Time | Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Regeneron Study Site | Long Beach | California | 90806 | United States |
| Regeneron Study Site | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| University of California | Sacramento | California | 95817 | United States |
| Regeneron Study Site | Stanford | California | 94305 | United States |
| James R Berenson MD Inc. | West Hollywood | California | 90069 | United States |
| University Of Colorado | Aurora | Colorado | 80045 | United States |
| Regeneron Study Site | North Haven | Connecticut | 06473-2195 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Arthritis and Rheumatic Disease Specialties | Aventura | Florida | 33180 | United States |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | United States |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | United States |
| Elixia COVID-19 | Hollywood | Florida | 33024 | United States |
| AppleMed Research Group, LLC | Miami | Florida | 33126 | United States |
| De La Cruz Research Center, LLC | Miami | Florida | 33184 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Florida Medical Clinic, LLC | Zephyrhills | Florida | 33542 | United States |
| Regeneron Study Site | Atlanta | Georgia | 30322 | United States |
| Regeneron Study Site | Marietta | Georgia | 30060 | United States |
| Great Lakes Clinical Trials - Ravenswood | Chicago | Illinois | 60625 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Institute of Human Virology | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Laboratory of Clinical Immunology and Microbiology, NIAID | Bethesda | Maryland | 20892 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Regeneron Study Site | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| Holy Name | Teaneck | New Jersey | 07666 | United States |
| Maimonides Cancer Center | Brooklyn | New York | 11220 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Regeneron Study Site | New York | New York | 10032-3729 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Regeneron Study Site 2 | New York | New York | 10065 | United States |
| Regeneron Study Site | Rochester | New York | 14642 | United States |
| Regeneron Study Site | Syracuse | New York | 13210 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13215 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Burke Primary Care | Morganton | North Carolina | 28655 | United States |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States |
| Regeneron Study Site | Cleveland | Ohio | 44195 | United States |
| Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Penn Prevention Clinical Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Regeneron Study Site | Providence | Rhode Island | 02903 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| PharmaTex Research, LLC | Amarillo | Texas | 79109 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| Therapeutic Concepts, PA | Houston | Texas | 77004 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Synergy Group Medical,LLC | Houston | Texas | 77087 | United States |
| Regeneron Study Site | Richmond | Virginia | 23219 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Regeneron Study Site | Seattle | Washington | 98109 | United States |
| Swedish Medical Center- First Hill | Seattle | Washington | 98122 | United States |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | United States |
| Regeneron Study Site | Cuauhtémoc | Mexico City | 6700 | Mexico |
| FG002 | Casirivimab+Imdevimab Q4W | casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W) |
| FG003 | Casirivimab+Imdevimab Q12W | casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W) |
| BG001 | Casirivimab+Imdevimab Initial + Q4W | Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W) |
| BG002 | Casirivimab+Imdevimab Q4W | casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W) |
| BG003 | Casirivimab+Imdevimab Q12W | casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP | Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases during the Efficacy Assessment Period (EAP) | Posted | Number | 95% Confidence Interval | Cumulative Incidence Percentage | The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the EAP | The safety analysis set (SAF) included all participants who received any study drug; it was based on the treatment received (as treated). Determination of "as treated" was based on the actual study drug received. Treatment compliance/administration and all clinical safety variables was analyzed using the SAF. | Posted | Number | Participants | The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the Follow-Up Period | The safety analysis set (SAF) included all participants who received any study drug; it was based on the treatment received (as treated). Determination of "as treated" was based on the actual study drug received. Treatment compliance/administration and all clinical safety variables was analyzed using the SAF. | Posted | Number | Participants | End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With TEAEs Leading to Study Drug Discontinuation During the EAP | Posted | Number | Participants | The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With TEAEs Leading to Study Drug Discontinuation During the Follow-Up Period | Posted | Number | Participants | End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the EAP | Posted | Number | Participants | The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Follow-Up Period | Posted | Number | Participants | End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events of Special Interest (AESIs) During the EAP | Posted | Number | Participants | The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Concentration of Casirivimab Over Time | The pharmacokinetic analysis set (PKAS) is defined for each analyte separately and includes all treated participants who received any amount of study drug (active or placebo [SAF]), and who had at least 1 non-missing result of respective total analyte following the first dose of study drug or placebo. The PKAS is based on the actual treatment received (as treated) rather than as randomized. | Posted | Mean | Standard Deviation | mg/L | Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group |
|
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| Secondary | Concentration of Imdevimab Over Time | The pharmacokinetic analysis set (PKAS) is defined for each analyte separately and includes all treated participants who received any amount of study drug (active or placebo [SAF]), and who had at least 1 non-missing result of respective total analyte following the first dose of study drug or placebo. The PKAS is based on the actual treatment received (as treated) rather than as randomized. | Posted | Mean | Standard Deviation | mg/L | Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Anti-drug Antibodies (ADA) Over Time | The ADA analysis set (AAS) is defined for each study drug separately and includes all treated participants who received any amount of study drug (active or placebo [SAF]) and had at least 1 non-missing ADA result following the first dose of study drug or placebo. The AAS is based on the actual treatment received (as treated) rather than as randomized. | Posted | Number | Participants | Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Neutralizing Antibodies (NAb) to Each mAb Over Time | The NAb analysis sets (NAbAS) comprises all treated participants (active or placebo) that were included in the AAS and tested negative at all ADA sampling times or tested positive at 1 or more post dose ADA sampling times and had at least 1 non-missing post dose NAb result (imputed or analysis result). The ADA analysis set (AAS) includes all treated participants who received any amount of study drug and had at least 1 non-missing ADA result following the first dose of study drug or placebo. | Posted | Number | Participants | Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group |
|
From first dose to end of follow up (approximately 7 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W) | 1 | 16 | 1 | 16 | 7 | 16 |
| EG001 | REGN10933+REGN10987 1200mg Loading Dose and 600mg SC Q4W | Co-administered casirivimab+imdevimab combination therapy, 1200 mg (600 mg per mAb) on day 1, then 600 mg (300 mg per mAb) SC Q4W | 1 | 17 | 1 | 17 | 5 | 17 |
| EG002 | REGN10933+REGN10987 300mg SC Q4W | Co-administered casirivimab+imdevimab combination therapy, 300 mg (150 mg per mAb) SC Q4W | 0 | 16 | 0 | 16 | 10 | 16 |
| EG003 | REGN10933+REGN10987 300mg SC Q12W | Co-administered casirivimab+imdevimab combination therapy, 300 mg (150 mg per mAb) SC Q12W | 0 | 17 | 2 | 17 | 8 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Middle ear effusion | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron Pharmaceuticals, Inc. | 8447346643 | clinicaltrials@regeneron.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2022 | May 16, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711751 | casirivimab and imdevimab drug combination |
| C000711487 | casirivimab |
| C000711488 | imdevimab |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hazard Ratio (HR) |
| 0.460 |
| 2-Sided |
| 95 |
| 0.072 |
| 2.929 |
| Superiority |
| Cox proportional hazard model | Cox Proportional Hazard | 0.609 | 2-Sided | 95 | 0.101 | 3.668 | Superiority |
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casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
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