HealthyPhase 1NCT04519437
Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19
A Phase 1 study testing REGN10933+REGN10987 in people with Healthy and Chronic Stable Illness, run by Regeneron Pharmaceuticals at 7 sites in United States.
Trial summary
The primary objectives are: To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Chronic Stable Illness
- What is being tested?
- REGN10933+REGN10987
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 974 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Jul 2020to 22 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study
- Stable medication for co-morbid condition(s) for at least 6 months prior to screening
- Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission
Who cannot join
- Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization
- Subject-reported clinical history of COVID-19 as determined by investigator
- Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection
- Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19
- Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening
- Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations) in the past 6 months prior to screening
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- Received investigational or approved SARS-CoV-2 vaccine
- Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol
- Use of remdesivir, intravenous immunoglobulin (IVIG), or other anti-SARS viral agents within 2 months prior to screening
- NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Regeneron Study Site
Austin, Texas, 78705
Regeneron Study Site
Dayton, Ohio, 45417
Regeneron Study Site
Lincoln, Nebraska, 68502
Regeneron Study Site
Miami, Florida, 33014
Regeneron Study Site
Rogers, Arkansas, 72758
Regeneron Study Site
Sacramento, California, 95864
Regeneron Study Site
Tempe, Arizona, 85283
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers
The primary objectives are:
- To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo
- To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration
The secondary objectives are:
- To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo
- To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration
- To assess the immunogenicity of REGN10933 and REGN10987
- Conditions
- Healthy, Chronic Stable Illness
- Being tested
- REGN10933+REGN10987, Placebo
- Keywords
- Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN10933+REGN10987Drug
Also called REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™
Administered subcutaneous (SC) every 4 weeks (Q4W)
PlaceboDrug
Administered subcutaneous (SC) every 4 weeks (Q4W)
| Study group | Role | What they receive |
|---|---|---|
| REGN10933+REGN10987 | Experimental | Not described Receives: Drug: REGN10933+REGN10987 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Measured: Within 4 days postdose at Baseline
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Measured: Within 4 days postdose at Day 29
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Measured: Within 4 days postdose at Day 57
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Measured: Within 4 days postdose at Day 85
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Measured: Within 4 days postdose at Day 113
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Measured: Within 4 days postdose at Day 141
Concentrations of REGN10933 in serum over time
Measured: Up to 52 weeks
Concentrations of REGN10987 in serum over time
Measured: Up to 52 weeks
Secondary outcomes (6)
Proportion of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to 52 weeks
Severity of TEAEs
Measured: Up to 52 weeks
Proportion of participants who achieve or exceed target concentration in serum of REGN10933
Measured: Up to 52 weeks
Proportion of participants who achieve or exceed target concentration in serum of REGN10987
Measured: Up to 52 weeks
Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933
Measured: Up to 52 weeks
Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start26 Jul 2020
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 974 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519437
- Sponsor's protocol ID
- R10933-10987-HV-2093
- Status last verified
- Jan 2022
- First submitted
- 24 Jul 2020
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Publications
Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
PubMed 35713300Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers
- ClinicalTrials.gov ID
- NCT04519437
- Acronym / sponsor ID
- R10933-10987-HV-2093
- Conditions
- Healthy, Chronic Stable Illness
- Keywords
- Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 974 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2020 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives are:
- To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo
- To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration
The secondary objectives are:
- To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo
- To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration
- To assess the immunogenicity of REGN10933 and REGN10987
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REGN10933+REGN10987 | Experimental | Drug: REGN10933+REGN10987 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study
- Stable medication for co-morbid condition(s) for at least 6 months prior to screening
- Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission
Key exclusion criteria (10 listed)
- Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization
- Subject-reported clinical history of COVID-19 as determined by investigator
- Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection
- Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19
- Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN10933+REGN10987Also: REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™Administered subcutaneous (SC) every 4 weeks (Q4W) | Drug | REGN10933+REGN10987 |
| PlaceboAdministered subcutaneous (SC) every 4 weeks (Q4W) | Drug | Placebo |
Primary outcome
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Time frame: Within 4 days postdose at Baseline
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Time frame: Within 4 days postdose at Day 29
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Time frame: Within 4 days postdose at Day 57
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Time frame: Within 4 days postdose at Day 85
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Time frame: Within 4 days postdose at Day 113
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Time frame: Within 4 days postdose at Day 141
Concentrations of REGN10933 in serum over time
Time frame: Up to 52 weeks
Concentrations of REGN10987 in serum over time
Time frame: Up to 52 weeks
6 secondary outcomes
Proportion of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 52 weeks
Severity of TEAEs
Time frame: Up to 52 weeks
Proportion of participants who achieve or exceed target concentration in serum of REGN10933
Time frame: Up to 52 weeks
Proportion of participants who achieve or exceed target concentration in serum of REGN10987
Time frame: Up to 52 weeks
Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933
Time frame: Up to 52 weeks
Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987
Time frame: Up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Derived from this study: PubMed 35713300Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN10933+REGN10987 in people with Healthy and Chronic Stable Illness, run by Regeneron Pharmaceuticals at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration (time frame: Within 4 days postdose at Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04519437, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.