COVID-19NCT04617535
Compassionate Use of REGN-COV2 for the Treatment of COVID-19
A study testing REGN10933+REGN10987 combination therapy in people with COVID-19, run by Regeneron Pharmaceuticals.
Trial summary
Compassionate Use requests will be considered for individuals who test positive for SARS-CoV-2 and where there is reasonable basis to believe that the patient is infected with a susceptible variant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- REGN10933+REGN10987 combination therapy
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Any age
- Child, Adult, Older adult
About this study
Compassionate Use requests will be considered for individuals who test positive for SARS-CoV-2 and where there is reasonable basis to believe that the patient is infected with a susceptible variant.
Read the detailed description
Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.
- Conditions
- COVID-19
- Being tested
- REGN10933+REGN10987 combination therapy
- Keywords
- Post-exposure
- 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+REGN10987 combination therapyDrug
Also called REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™
Administered intravenously (IV) single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617535
- Sponsor's protocol ID
- R10933-10987-COV
- Status last verified
- Sep 2023
- First submitted
- 2 Nov 2020
- Last updated
- 3 Oct 2023
- Results posted
- No
Publications
Kreuzberger 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 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of REGN-COV2 for the Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04617535
- Acronym / sponsor ID
- R10933-10987-COV
- Conditions
- COVID-19
- Keywords
- Post-exposure
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 5 Nov 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.
Compassionate Use requests will be considered for individuals who test positive for SARS-CoV-2 and where there is reasonable basis to believe that the patient is infected with a susceptible variant.
Detailed description
Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.
Study design
Who may qualify
- Age groups
- Child, Adult, Older adult
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+REGN10987 combination therapyAlso: REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™Administered intravenously (IV) single dose | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing REGN10933+REGN10987 combination therapy in people with COVID-19, run by Regeneron Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617535, which also lists 1 linked publication.
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 3 Oct 2023.