Compassionate Use of REGN-COV2 for the Treatment of COVID-19
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| ClinicalTrials.gov Identifier: NCT04617535 |
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Expanded Access Status :
No longer available
First Posted : November 5, 2020
Last Update Posted : October 3, 2023
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Sponsor:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
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| Tracking Information | |
|---|---|
| First Submitted Date | November 2, 2020 |
| First Posted Date | November 5, 2020 |
| Last Update Posted Date | October 3, 2023 |
| Descriptive Information | |
| Brief Title | Compassionate Use of REGN-COV2 for the Treatment of COVID-19 |
| Official Title | Not Provided |
| Brief 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. |
| Detailed Description | Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications. |
| Study Type | Expanded Access |
| Expanded Access Type | Individual Patients |
| Condition | COVID-19 |
| Intervention | Drug: REGN10933+REGN10987 combination therapy
Administered intravenously (IV) single dose
Other Names:
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| 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. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Expanded Access Status | No longer available |
| Eligibility Criteria | Not Provided |
| Sex/Gender | Not Provided |
| Ages | Child, Adult, Older Adult |
| Contacts | Contact information is only displayed when the study is recruiting subjects |
| Listed Location Countries | Not Provided |
| Removed Location Countries | |
| Administrative Information | |
| NCT Number | NCT04617535 |
| Other Study ID Numbers | R10933-10987-COV |
| Current Responsible Party | Regeneron Pharmaceuticals |
| Original Responsible Party | Same as current |
| Current Study Sponsor | Regeneron Pharmaceuticals |
| Original Study Sponsor | Same as current |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| PRS Account | Regeneron Pharmaceuticals |
| Verification Date | September 2023 |