COVID-19Phase 1NCT05092581
COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19
A Phase 1 study testing casirivimab+imdevimab in people with COVID-19, run by Regeneron Pharmaceuticals at 2 sites in United States.
Trial summary
The primary objectives of the study are: To characterize the concentrations of casirivimab+imdevimab in serum over time To evaluate the safety and tolerability of casirivimab+imdevimab The secondary objective of the study is: To assess the immunogenicity of casirivimab+imdevimab Read more about this study
- Who is it for?
- Ages 1 minute to 17 years
- Conditions the study is for
- COVID-19
- 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
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Dec 2021to 9 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 1 minute to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Has SARS-CoV-2 positive antigen or molecular diagnostic test ≤72 hours prior to study enrollment Note: historical record of positive result is acceptable as long as the sample was collected ≤72 hours prior to enrollment
- Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤ 14 days before dosing
- Hospitalized due to COVID-19
- Provide informed consent signed by study patient or legally acceptable representative/guardian
Who cannot join
- In the opinion of the investigator, unlikely to survive for >96 hours from screening
- Neonates having gestational age of <29 weeks and weight <1.1 kg
- Receiving extracorporeal membrane oxygenation (ECMO)
- Has new-onset stroke or seizure disorder during hospitalization
- Initiated on renal replacement therapy due to COVID-19
- Has circulatory shock requiring vasopressors on dosing day Note: Patients who require vasopressors for sedation-related hypotension or reasons other than circulatory shock may be eligible in this study
Show all 12Show fewer
- Participation in a clinical research study, including any double-blind study, evaluating an investigational product within 30 days and less than 5 half-lives of the investigational product prior to the screening visit
- Members of the clinical site study team and/or their immediate family
- Plans to receive an investigational or approved SARS-CoV-2 vaccine within 90 days after study drug administration based on current Centers for Disease Control vaccination guidelines (CDC, 2021). Refer to the latest CDC guidance for any updates.
- Note: Patients who have already completed vaccination prior to study enrollment may be allowed in the study.
- Prior use (within 90 days prior to study drug administration) or current use of any investigational, authorized, or approved passive antibody for prophylaxis of SARS-CoV-2 infection, including convalescent plasma, convalescent sera, hyperimmune globulin, or other monoclonal antibodies (eg, bamlanivimab and etesevimab, sotrovimab)
- Note: Other protocol defined Inclusion/ Exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
State University of New York at Stony Brook
Stony Brook, New York, 11794
About this study
Official title: A Phase 1b, Open-Label, Single Dose Study Assessing the Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19
The primary objectives of the study are:
- To characterize the concentrations of casirivimab+imdevimab in serum over time
- To evaluate the safety and tolerability of casirivimab+imdevimab
The secondary objective of the study is:
- To assess the immunogenicity of casirivimab+imdevimab
- Conditions
- COVID-19
- Being tested
- casirivimab+imdevimab
- Keywords
- Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
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, REGN10933, REGN10987, REGEN-COV™
Single dose weight-based equivalent administered intravenously (IV)
| Study group | Role | What they receive |
|---|---|---|
| casirivimab+imdevimab | Experimental | Not described Receives: Drug: casirivimab+imdevimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of casirivimab+imdevimab in serum over time
Measured: Through day 169
Proportion of patients with treatment-emergent serious adverse events (SAEs)
Measured: Through day 29
Proportion of patients with infusion-related reactions
Measured: Through day 4
Proportion of patients with hypersensitivity reactions
Measured: Through day 29
Secondary outcomes (2)
Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time
Measured: Through day 169
Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time
Measured: Through day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start16 Dec 2021
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Why it stopped: Emerging SARS-CoV-2 variants impacting susceptibility to study drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 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
- NCT05092581
- Sponsor's protocol ID
- R10933-10987-COV-2114
- Other IDs
- 2021-004535-84
- Status last verified
- Oct 2025
- First submitted
- 22 Oct 2021
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1b, Open-Label, Single Dose Study Assessing the Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19
- ClinicalTrials.gov ID
- NCT05092581
- Acronym / sponsor ID
- R10933-10987-COV-2114
- Conditions
- COVID-19
- Keywords
- Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), coronavirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Emerging SARS-CoV-2 variants impacting susceptibility to study drug
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 25 Oct 2021 (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 of the study are:
- To characterize the concentrations of casirivimab+imdevimab in serum over time
- To evaluate the safety and tolerability of casirivimab+imdevimab
The secondary objective of the study is:
- To assess the immunogenicity of casirivimab+imdevimab
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| casirivimab+imdevimab | Experimental | Drug: casirivimab+imdevimab |
Who may qualify
- Ages
- 1 minute to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Has SARS-CoV-2 positive antigen or molecular diagnostic test ≤72 hours prior to study enrollment Note: historical record of positive result is acceptable as long as the sample was collected ≤72 hours prior to enrollment
- Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤ 14 days before dosing
- Hospitalized due to COVID-19
- Provide informed consent signed by study patient or legally acceptable representative/guardian
Key exclusion criteria (12 listed)
- In the opinion of the investigator, unlikely to survive for >96 hours from screening
- Neonates having gestational age of <29 weeks and weight <1.1 kg
- Receiving extracorporeal membrane oxygenation (ECMO)
- Has new-onset stroke or seizure disorder during hospitalization
- Initiated on renal replacement therapy due to COVID-19
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, REGN10933, REGN10987, REGEN-COV™Single dose weight-based equivalent administered intravenously (IV) | Drug | casirivimab+imdevimab |
Primary outcome
Concentrations of casirivimab+imdevimab in serum over time
Time frame: Through day 169
Proportion of patients with treatment-emergent serious adverse events (SAEs)
Time frame: Through day 29
Proportion of patients with infusion-related reactions
Time frame: Through day 4
Proportion of patients with hypersensitivity reactions
Time frame: Through day 29
2 secondary outcomes
Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time
Time frame: Through day 169
Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time
Time frame: Through day 169
Results and safety
The study was stopped early (reason given: Emerging SARS-CoV-2 variants impacting susceptibility to study drug). Results are not available in the source record.
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 COVID-19, 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 4 inclusion and 12 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: stopped early, 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 was stopped early (reason given: Emerging SARS-CoV-2 variants impacting susceptibility to study drug). Results are not available in the source record.
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?
Concentrations of casirivimab+imdevimab in serum over time (time frame: Through day 169). The study lists 4 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.