Brief Summary
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:
* To evaluate the safety and tolerability of repeated SC injections of casirivimab+imdevimab in the study population
* To characterize concentrations of casirivimab and imdevimab in serum over time
* To assess the immunogenicity of casirivimab and imdevimab
The secondary objectives of the study are:
* To evaluate the safety and tolerability of repeated SC injections of casirivimab+imdevimab in the study population
* To characterize concentrations of casirivimab and imdevimab in serum over time
* To assess the immunogenicity of casirivimab and imdevimab
Brief Title
A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults
Categories
Completion Date
Completion Date Type
Actual
Conditions
Immunocompromised
Eligibility Criteria
Key Inclusion Criteria:
1. 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
2. Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine
3. 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
4. Tested negative for the COVID-19 virus within 72 hours prior to randomization
Key Exclusion Criteria:
1. Weighs \<40 kg (only applies to participants ≥12 to \<18 years of age)
2. Has any signs or symptoms consistent with COVID-19
3. Past COVID-19 infection within 90 days prior to randomization
4. Planned use of any investigational, authorized, or approved vaccine for COVID-19 within 90 days of the last dose of study drug
5. Prior, current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any COVID-19 treatment
6. 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
7. Has any known active acute respiratory infection
8. Has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection
9. Has known allergy or hypersensitivity to components of the study drugs
NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
1. 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
2. Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine
3. 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
4. Tested negative for the COVID-19 virus within 72 hours prior to randomization
Key Exclusion Criteria:
1. Weighs \<40 kg (only applies to participants ≥12 to \<18 years of age)
2. Has any signs or symptoms consistent with COVID-19
3. Past COVID-19 infection within 90 days prior to randomization
4. Planned use of any investigational, authorized, or approved vaccine for COVID-19 within 90 days of the last dose of study drug
5. Prior, current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any COVID-19 treatment
6. 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
7. Has any known active acute respiratory infection
8. Has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection
9. Has known allergy or hypersensitivity to components of the study drugs
NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
Inclusion Criteria
Inclusion Criteria:
1. 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
2. Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine
3. 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
4. Tested negative for the COVID-19 virus within 72 hours prior to randomization
Inclusion/
1. 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
2. Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine
3. 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
4. Tested negative for the COVID-19 virus within 72 hours prior to randomization
Inclusion/
Gender
All
Gender Based
false
Keywords
Non-response to COVID-19 vaccination
COVID-19
Immunocompromised, weakened immune system
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
12 Years
NCT Id
NCT05074433
Org Class
Industry
Org Full Name
Regeneron Pharmaceuticals
Org Study Id
R10933-10987-COV-2176
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies as Pre-Exposure Prophylaxis to Prevent COVID-19 in Immunocompromised Participants
Primary Outcomes
Outcome Description
Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases during the Efficacy Assessment Period (EAP)
Outcome Measure
Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP
Outcome Time Frame
The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Secondary Ids
Secondary Id
2021-005222-14
Secondary Outcomes
Outcome Time Frame
The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Outcome Measure
Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the EAP
Outcome Time Frame
End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Outcome Measure
Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the Follow-Up Period
Outcome Time Frame
The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Outcome Measure
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the EAP
Outcome Time Frame
End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Outcome Measure
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the Follow-Up Period
Outcome Time Frame
The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Outcome Measure
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the EAP
Outcome Time Frame
End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Outcome Measure
Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Follow-Up Period
Outcome Time Frame
The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Outcome Measure
Incidence of Adverse Events of Special Interest (AESIs) During the EAP
Outcome Time Frame
Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Outcome Measure
Concentration of Casirivimab Over Time
Outcome Time Frame
Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Outcome Measure
Concentration of Imdevimab Over Time
Outcome Time Frame
Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Outcome Measure
Incidence of Anti-drug Antibodies (ADA) Over Time
Outcome Time Frame
Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Outcome Measure
Incidence of Neutralizing Antibodies (NAb) to Each mAb Over Time
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Margaret Mccort
Investigator Email
mnewmanmcc@montefiore.org
Investigator Phone
718-920-7361