A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults

Immunocompromised Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05074433
• Other study ID #: R10933-10987-COV-2176
• Secondary ID: 2021-005222-14
• Status: Terminated
• Phase: Phase 3
• Start date: October 25, 2021
• Est. completion date: May 18, 2022

Study information

• Verified date: June 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: May 18, 2022
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Immunocompromised

Intervention

Drug:
• casirivimab+imdevimab
Co-administered sequentially subcutaneous (SC)
• Placebo
Administered SC

Locations

Country	Name	City	State
Mexico	Regeneron Study Site	Cuauhtemoc	Distrito Federal
United States	PharmaTex Research, LLC	Amarillo	Texas
United States	University of Michigan	Ann Arbor	Michigan
United States	Regeneron Study Site	Atlanta	Georgia
United States	University Of Colorado	Aurora	Colorado
United States	Central Texas Clinical Research	Austin	Texas
United States	Arthritis and Rheumatic Disease Specialties	Aventura	Florida
United States	Institute of Human Virology	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Laboratory of Clinical Immunology and Microbiology, NIAID	Bethesda	Maryland
United States	Central Alabama Research	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Regeneron Study Site	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Maimonides Cancer Center	Brooklyn	New York
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	Great Lakes Clinical Trials - Ravenswood	Chicago	Illinois
United States	Innovative Research of West Florida, Inc.	Clearwater	Florida
United States	Regeneron Study Site	Cleveland	Ohio
United States	Miami Valley Hospital	Dayton	Ohio
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Midway Immunology and Research Center	Fort Pierce	Florida
United States	Spectrum Health	Grand Rapids	Michigan
United States	Elixia COVID-19	Hollywood	Florida
United States	Houston Methodist Hospital	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Synergy Group Medical,LLC	Houston	Texas
United States	Therapeutic Concepts, PA	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Regeneron Study Site	Long Beach	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Regeneron Study Site	Los Angeles	California
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Regeneron Study Site	Marietta	Georgia
United States	AppleMed Research Group, LLC	Miami	Florida
United States	De La Cruz Research Center, LLC	Miami	Florida
United States	Burke Primary Care	Morganton	North Carolina
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Tulane University	New Orleans	Louisiana
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Regeneron Study Site	New York	New York
United States	Regeneron Study Site 2	New York	New York
United States	Regeneron Study Site	North Haven	Connecticut
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Stanford University	Palo Alto	California
United States	Penn Prevention Clinical Research Site	Philadelphia	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania
United States	Regeneron Study Site	Providence	Rhode Island
United States	Regeneron Study Site	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Regeneron Study Site	Rochester	New York
United States	University of California	Sacramento	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Regeneron Study Site	Seattle	Washington
United States	Swedish Medical Center- First Hill	Seattle	Washington
United States	Regeneron Study Site	Stanford	California
United States	Regeneron Study Site	Syracuse	New York
United States	SUNY Upstate Medical University	Syracuse	New York
United States	University of South Florida	Tampa	Florida
United States	Holy Name	Teaneck	New Jersey
United States	Georgetown University	Washington	District of Columbia
United States	James R Berenson MD Inc.	West Hollywood	California
United States	Florida Medical Clinic, LLC	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	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 EAP		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		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		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		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		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		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		The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Secondary	Concentration of Casirivimab Over Time		Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Secondary	Concentration of Imdevimab Over Time		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		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		Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group