UMEM Research Studies

REGENERON 2067

Sponsor: Regeneron Pharmaceuticals | Status: Recruiting

Start Date: 10/01/2020 | End Date: -

Principal Investigator(s)
Gentry Wilkerson

Secondary Investigator(s)

Description:

Title: A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-SPIKE SARS-COV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients with COVID-19.

 

Site Principal Investigator: R. Gentry Wilkerson, MD, FACEP, FAAEM

Sub-Investigators (Institute of Human Virology): 

1- Joel Chua, MD

2- Shivakumar Narayanan, MBBS

Research Team: 

Dana Beach (dbeach3@som.umaryland.edu)

Kyra Lasko (kyra.lasko@som.umaryland.edu)

Youssef Annous (yannous@som.umaryland.edu)

Sponsor: Regeneron Pharmaceuticals

Objectives: To evaluate the safety, tolerability, and efficacy of Monoclonal Anti-SPIKE antibodies, REGN10933+REGN10987 and REGN10989 in ambulatory patients with COVID-19. 

 

Study design: A randomized, double-blinded, placebo-controlled, adaptive phase 1/2/3 master protocol will assess the safety, tolerability, and efficacy of REGN10933+REGN10987 and REGN10989 in ambulatory patients with COVID-19. The multicenter conduct of this study will enable generalizable evidence of the safety, tolerability, and efficacy of these investigational mAbs for COVID-19.

Key Inclusion Criteria:

  • Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization. A historical record of positive result is acceptable as long as the sample was collected ≤72 hours prior to randomization
  • (Cohort 1): Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization, or
  • (Cohort 2): Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization, or is asymptomatic at randomization and has no prior symptoms consistent with COVID-19 (as determined by the investigator)
  • Maintains O2 saturation ≥93% on room air
  • Is able to understand and complete study-related questionnaires (cohort 1 and cohort 2 patients aged ≥12 years only)

Key Exclusion Criteria:

  • Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
  • Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
  • Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)

Brief Summary:

Phase 1

  • To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
  • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2

Phase 2 • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2

Phase 3

  • Cohort 1 (Patients ≥18 Years)

    • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by COVID-19-related medically-attended visits

  • Cohort 2 (Patients 0 to <18 Years)

    • To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
    • To characterize further the concentrations of REGN10933 and REGN10987 in serum over time
    • To assess the immunogenicity of REGN10933 and REGN10987

 

Keywords: SARS-CoV-2, COVID-19, Regeneron, SPIKE, Anti-SPIKE, Monoclonal Antibody