Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

974 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-26

Study Completion Date

2021-11-22

Brief Summary

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The primary objectives are:

* To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo
* To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration

The secondary objectives are:

* To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo
* To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration
* To assess the immunogenicity of REGN10933 and REGN10987

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Detailed Description

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Conditions

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Healthy Chronic Stable Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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REGN10933+REGN10987

Group Type EXPERIMENTAL

REGN10933+REGN10987

Intervention Type DRUG

Administered subcutaneous (SC) every 4 weeks (Q4W)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered subcutaneous (SC) every 4 weeks (Q4W)

Interventions

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REGN10933+REGN10987

Administered subcutaneous (SC) every 4 weeks (Q4W)

Intervention Type DRUG

Placebo

Administered subcutaneous (SC) every 4 weeks (Q4W)

Intervention Type DRUG

Other Intervention Names

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REGN-COV2 Casirivimab Imdevimab REGEN-COV™ Ronapreve™

Eligibility Criteria

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Inclusion Criteria

1. Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study
2. Stable medication for co-morbid condition(s) for at least 6 months prior to screening
3. Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission

Exclusion Criteria

1. Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization
2. Subject-reported clinical history of COVID-19 as determined by investigator
3. Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection
4. Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19
5. Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, \>24 hours) for any reason within 30 days prior to screening
6. Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease \[COPD\], asthma exacerbations) in the past 6 months prior to screening
7. Received investigational or approved SARS-CoV-2 vaccine
8. Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol
9. Use of remdesivir, intravenous immunoglobulin (IVIG), or other anti-SARS viral agents within 2 months prior to screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes