Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN10933+ REGN10987 · 1 trial · 1 indication
Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.
The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US).
| Arm | Type | Description |
|---|---|---|
| REGN10933 + REGN10987 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| REGN10933 + REGN10987 | DRUG | Subcutaneous (SC) or Intramuscular (IM) injections |
| Placebo | DRUG | SC or IM injections |
Key Inclusion Criteria: 1. Adult subjects 18 years of age (irrespective of weight) and above at the signing of informed consent or adolescent participants ≥12 to \<18 years of age, or pediatric participants \<12 years of age at the signing of the assent (parent/guardian sign the informed consent) 2...
REGN10933+REGN10987 is an investigational combination of two monoclonal antibodies being studied for the prevention and treatment of COVID-19. It has been evaluated in clinical trials for hospitalized adult patients with COVID-19, for prevention of SARS-CoV-2 infection in healthy adults and adolescents who are household contacts of infected individuals, and in healthy adult volunteers.
REGN10933+REGN10987 targets the spike (S) protein of SARS-CoV-2, the virus that causes COVID-19. The combination consists of two anti-spike monoclonal antibodies designed to bind to the spike protein and potentially neutralize the virus.
REGN10933+REGN10987 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company has conducted multiple clinical trials to evaluate the safety and efficacy of this antibody combination for COVID-19.
REGN10933+REGN10987 has completed Phase 1, Phase 2, and Phase 3 clinical trials. The trials include a Phase 3 study for prevention of SARS-CoV-2 infection in healthy adults and adolescents, and a Phase 1/2/3 study for hospitalized adult patients with COVID-19. All trials are completed.
REGN10933+REGN10987 has been studied in four completed clinical trials. NCT04426695 evaluated its efficacy in hospitalized adults with COVID-19. NCT04452318 assessed its efficacy for prevention of SARS-CoV-2 infection in healthy household contacts. NCT04519437 studied safety, tolerability, and pharmacokinetics in healthy volunteers. NCT04666441 evaluated virologic efficacy in adult outpatients with SARS-CoV-2 infection.
REGN10933+REGN10987 is a combination of two monoclonal antibodies, REGN10933 and REGN10987, administered together. The combination is sometimes referred to by the individual component names, but in clinical trials it is studied as a fixed combination product.