HealthyPhase 1NCT05181683
COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers
A Phase 1 study testing Casirivimab+Imdevimab in people with Healthy and Chronic Stable Illness, run by Regeneron Pharmaceuticals at 2 sites in United States.
Trial summary
The primary objective of the study is to assess the safety and tolerability of co-formulated subcutaneous (SC) and intravenous (IV) casirivimab+imdevimab The secondary objectives of the study are to: Explore variability in the drug concentration profiles of casirivimab and imdevimab after co-formulated subcutaneous… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Chronic Stable Illness
- What is being tested?
- Casirivimab+Imdevimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jan 2022to 3 Jun 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is healthy, or has chronic medical condition(s) that per the opinion of the investigator is (are) stable, well-controlled, and not likely to require medical intervention through the end of study
- Does not require medication(s) for co-morbid condition, or has received stable medication(s) for co-morbid condition(s) for at least 6 months prior to screening
- Weighs between ≥60 kg and ≤100 kg at the time of screening
- Has SARS-CoV-2-negative reverse-transcriptase polymerase chain reaction (RT-PCR) from a sample collected ≤72 hours prior to randomization, using local assay and sample collection and assay standards
- Has completed a full course of COVID-19 vaccination more than 6 weeks prior to randomization
Who cannot join
- Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator
- Has recent SARS-CoV-2 infection that resolved within 6 weeks prior to randomization
- Prior use of casirivimab+imdevimab at any time prior to randomization
- Prior, current, or planned use during the study of any of the following treatments: COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 (eg, bamlanivimab and etesevimab, sotrovimab), intravenous immunoglobulin (any indication), or any other investigational, authorized, or approved agent intended for COVID-19 treatment or prevention (with the exception of COVID-19 vaccines)
- Treatment with another investigational drug in the last 30 days or within 5 half-lives of the investigational drug, whichever is longer, prior to screening
- Body mass index (BMI) ≥28 kg/m2
Show all 13Show fewer
- Medically-attended acute illness, systemic antibiotics use, or hospitalization 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
- Uncontrolled hypertension, in the opinion of the investigator
- History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure (coronary, carotid, or peripheral vascular), or intracardiac device placement (eg, pacemaker) within 12 months prior to screening
- Cancer requiring treatment currently or in the past 5 years, except for non-melanoma skin cancer or cervical/anus in-situ
- Is pregnant at screening
- Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Regeneron Study Site
Miami, Florida, 33186
Regeneron StudySite
Winter Park, Florida, 32789
About this study
Official title: A Phase 1, Randomized, Open-Label Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers
The primary objective of the study is to assess the safety and tolerability of co-formulated subcutaneous (SC) and intravenous (IV) casirivimab+imdevimab
The secondary objectives of the study are to:
- Explore variability in the drug concentration profiles of casirivimab and imdevimab after co-formulated subcutaneous (SC) or intravenous (IV) administration
- Characterize the immunogenicity of casirivimab and imdevimab in serum over time
- Conditions
- Healthy, Chronic Stable Illness
- Being tested
- Casirivimab+Imdevimab
- 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.
Casirivimab+ImdevimabDrug
Also called REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™
Randomized 1:1 for intravenous (IV) or subcutaneous (SC) administration
| Study group | Role | What they receive |
|---|---|---|
| Co-formulated casirivimab+imdevimab SC | Experimental | Randomized 1:1 Receives: Drug: Casirivimab+Imdevimab |
| Co-formulated casirivimab+imdevimab IV | Experimental | Randomized 1:1 Receives: Drug: Casirivimab+Imdevimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted grade ≥3 treatment-emergent adverse events (TEAEs)
Measured: Through end of study, approximately 16 weeks
Grade ≥3 injection-site reactions (ISRs)
Measured: Through end of study, approximately 16 weeks
Grade ≥2 infusion-related reactions (IRRs)
Measured: Through end of study, approximately 16 weeks
Grade ≥2 hypersensitivity reactions
Measured: Through end of study, approximately 16 weeks
Serious adverse events (SAEs)
Measured: Through end of study, approximately 16 weeks
Secondary outcomes (3)
Concentrations of casirivimab and imdevimab in serum over time
Measured: Up to 16 weeks
Incidence and titer of anti-drug antibodies (ADA) to casirivimab and imdevimab
Measured: Up to 16 weeks
Incidence of neutralizing antibodies (NAb) to casirivimab and imdevimab
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start7 Jan 2022
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 45 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
- NCT05181683
- Sponsor's protocol ID
- R10933-10987-COV-2179
- Status last verified
- Oct 2025
- First submitted
- 4 Jan 2022
- Last updated
- 14 Oct 2025
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers
- ClinicalTrials.gov ID
- NCT05181683
- Acronym / sponsor ID
- R10933-10987-COV-2179
- 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
- 45 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 6 Jan 2022 (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 objective of the study is to assess the safety and tolerability of co-formulated subcutaneous (SC) and intravenous (IV) casirivimab+imdevimab
The secondary objectives of the study are to:
- Explore variability in the drug concentration profiles of casirivimab and imdevimab after co-formulated subcutaneous (SC) or intravenous (IV) administration
- Characterize the immunogenicity of casirivimab and imdevimab in serum over time
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-formulated casirivimab+imdevimab SC | Experimental | Drug: Casirivimab+ImdevimabRandomized 1:1 |
| Co-formulated casirivimab+imdevimab IV | Experimental | Drug: Casirivimab+ImdevimabRandomized 1:1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is healthy, or has chronic medical condition(s) that per the opinion of the investigator is (are) stable, well-controlled, and not likely to require medical intervention through the end of study
- Does not require medication(s) for co-morbid condition, or has received stable medication(s) for co-morbid condition(s) for at least 6 months prior to screening
- Weighs between ≥60 kg and ≤100 kg at the time of screening
- Has SARS-CoV-2-negative reverse-transcriptase polymerase chain reaction (RT-PCR) from a sample collected ≤72 hours prior to randomization, using local assay and sample collection and assay standards
- Has completed a full course of COVID-19 vaccination more than 6 weeks prior to randomization
Key exclusion criteria (13 listed)
- Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator
- Has recent SARS-CoV-2 infection that resolved within 6 weeks prior to randomization
- Prior use of casirivimab+imdevimab at any time prior to randomization
- Prior, current, or planned use during the study of any of the following treatments: COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 (eg, bamlanivimab and etesevimab, sotrovimab), intravenous immunoglobulin (any indication), or any other investigational, authorized, or approved agent intended for COVID-19 treatment or prevention (with the exception of COVID-19 vaccines)
- Treatment with another investigational drug in the last 30 days or within 5 half-lives of the investigational drug, whichever is longer, 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 |
|---|---|---|
| Casirivimab+ImdevimabAlso: REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™Randomized 1:1 for intravenous (IV) or subcutaneous (SC) administration | Drug | Co-formulated casirivimab+imdevimab IV, Co-formulated casirivimab+imdevimab SC |
Primary outcome
Targeted grade ≥3 treatment-emergent adverse events (TEAEs)
Time frame: Through end of study, approximately 16 weeks
Grade ≥3 injection-site reactions (ISRs)
Time frame: Through end of study, approximately 16 weeks
Grade ≥2 infusion-related reactions (IRRs)
Time frame: Through end of study, approximately 16 weeks
Grade ≥2 hypersensitivity reactions
Time frame: Through end of study, approximately 16 weeks
Serious adverse events (SAEs)
Time frame: Through end of study, approximately 16 weeks
3 secondary outcomes
Concentrations of casirivimab and imdevimab in serum over time
Time frame: Up to 16 weeks
Incidence and titer of anti-drug antibodies (ADA) to casirivimab and imdevimab
Time frame: Up to 16 weeks
Incidence of neutralizing antibodies (NAb) to casirivimab and imdevimab
Time frame: Up to 16 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 14 Oct 2025.
- 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
2 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 Casirivimab+Imdevimab in people with Healthy and Chronic Stable Illness, run by Regeneron Pharmaceuticals at 2 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 5 inclusion and 13 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 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Targeted grade ≥3 treatment-emergent adverse events (TEAEs) (time frame: Through end of study, approximately 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2025.