# CoVPN 3502 A Phase 3, Randomized, Double LOC GY16

> **NIH NIH UM1** · FRED HUTCHINSON CANCER CENTER · 2022 · $293,963

## Abstract

Project Abstract
Efforts to control the pandemic have resulted in widespread shelter-in-place orders. Transmission of SARS-
CoV-2 occurs primarily through person-to-person contact and respiratory droplet transmission (Lai,2020).
Household contacts of a person infected with SARS-CoV-2 are at a high risk for acquiring infection, with
transmission rates ranging from approximately 10% to 15%. The majority of individuals who acquire infection
from household contacts develop symptoms of COVID-19(Burke,2020) (Jing, 2020), (Bi,2020) (Li,2020b).
Prophylaxis is urgently needed to reduce transmission rates and/or reduce the occurrence of symptomatic
disease.
Ideally, prophylaxis would need to be given as soon as possible after a known exposure, as the duration of
time between symptomatic infection in the source individual and the development of symptoms in newly
infected individual is thought to be approximately 5 days, with a possible range of 2 to14 days(Lauer,2020)
(Li,2020a). Animal models suggest that SARS-CoV-2 RT-PCR in nasopharyngeal (NP) samples become
positive within a few days after infection (Rockx,2020). An ideal agent for prophylaxis should be fast acting and
highly effective and should protect against multiple viral variants. A monoclonal antibody (mAb) combination
therapy, with two different monoclonal antibodies that bind distinct regions of the portion of the SARS-CoV-2
spike(S) protein that bind to and facilitate entry into host cells, has been developed in order to achieve these
goals.
A mAb combination against SARS-CoV-2 for post-exposure prophylaxis that can either prevent the
development of disease or reduce viral acquisition or shedding could be key to reducing transmission of the
virus and limiting symptoms and adverse outcomes following infection.
Currently, however, there is no approved prophylaxis for COVID-19 nor for patients that are infected with
SARS-CoV-2 but are asymptomatic. Given the speed at which this outbreak has spread and how it has
impacted almost every community globally, there is an urgent need to develop safe and efficacious
interventions to slow the spread of the SARS-CoV-2 virus and decrease adverse outcomes associated with
symptomatic disease.
This is a pivotal phase 3 randomized, double-blind, placebo-controlled study in adults with household contact
exposure to individuals with SARS-CoV-2 infection in geographic areas with an active COVID-19 outbreak.
This study is designed to assess the efficacy and safety of co-administered REGN10933+REGN10987
combination therapy (“REGN10933+REGN10987”) to reduce the proportion of SARS-CoV-2 infections and
prevent the development of COVID-19 disease (symptomatic SARS-CoV2 infection), after household exposure
to individuals with SARS-CoV-2 infection. Safety, tolerability, pharmacokinetics (PK), and immunogenicity of
REGN10933+REGN10987 will also be evaluated.

## Key facts

- **NIH application ID:** 10581187
- **Project number:** 3UM1AI068614-17S4
- **Recipient organization:** FRED HUTCHINSON CANCER CENTER
- **Principal Investigator:** Dan H. Barouch
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $293,963
- **Award type:** 3
- **Project period:** 2006-06-29 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10581187

## Citation

> US National Institutes of Health, RePORTER application 10581187, CoVPN 3502 A Phase 3, Randomized, Double LOC GY16 (3UM1AI068614-17S4). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10581187. Licensed CC0.

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