Below is a list of the current active Biorepository studies.

Study Title

Principal Investigator(s)

Study Start Date

Study Summary

Serum and Saliva COVID-19 Antibody Assay with EFIRM

Natasha Hochberg, MD

June 2020

The goal of this sub-study is to develop a diagnostic assay for COVID-19 antibody detection in clinical samples using Electric Field Induced Release and Measurement (EFIRM). The availability of a noninvasive assay for COVID-19 antibodies would be an important advance as it would enable population-based monitoring of immunity and allow the testing of health care workers and first responders to determine who has been infected and now probably has immunity to the virus. The EFIRM technology is unique in allowing the rapid, high sensitivity direct detection of biomarkers from <60 uL of serum, plasma or saliva without complex sample preparation and with rapid turn-around time (2 hours) and at a reasonable cost (<$3.00/sample).

Clinical Outcome of COVID-19 infection and nasopharyngeal bacterial community

Stephen Pelton, MD

Rotem Lapidot, MD

June 2020

It is increasingly clear that viral-bacterial interactions occur in a bidirectional manner.  We hypothesize interactions between Coronaviruses and SARS-CoV-2 are likely to influence disease course. We will characterize the nasopharyngeal microbiome in COVID+ and COVID- age matched, individuals and correlate with presence of disease and severity. We will also evaluate prevalence, density, and serotype distribution of pneumococcal colonization in each population.

SARS-CoV-2 Transmission Occurrences among healthcare Personnel (STOP)

Karen Jacobson, MD MPH

June 2020

Hospital-associated transmission of SARS-CoV-2 is recognized a route of COVID-19 spread that urgently needs to be protected against. In order to decrease infection rates in this setting, an improved understanding of transmission and risk is needed. We will use contact tracing and epidemiologic data, supplemented with viral genome sequencing, to understand how and where (e.g., hospital or community) transmission occurs amongst HCP at Boston Medical Center. We will identify risks associated with HCP getting infected with SARS-CoV-2 and also assess the impact of hospital infection control policy on the course of the COVID-19 outbreak among BMC employees.

Role of microvascular thrombosis with SARS-CoV-2

Vipul Chitalia, MD

July 2020

Our focus is to investigate the mechanisms of endothelial damage and thrombosis in patients with Coronavirus infection. Although the pulmonary complications are the most common, acute kidney injury (AKI) occurs in ~9-20% of severe COVID-19 patients. AKI is an adverse prognostic factor for COVID-19 patients complicating their management of ventilation, volume, acid-base and electrolyte homeostasis.

Impact of Oral Microbiota on COVID-19 Disease Severity

Wendy Kuohung, MD

September 2020

Prior studies have shown that commensal microbiota in different body sites both protect against and increase susceptibility to viruses via direct (blocking cell internalization, adsorptive trapping, virus binding, etc.) and indirect mechanisms (enhancing type I IFN signaling, increasing macrophage antiviral activity, etc). We hypothesize that the oral microbiome profiles of COVID-19 patients with severe disease will differ from those with mild disease.

Identification of transcriptional pathways and cell states associated with COVID19 severity in minority and underserved populations

Joshua Campbell, PhD and W. Evan Johnson, PhD

September 2020

In this study, we will conduct RNA sequencing on nasopharyngeal (NP) specimen from COVID-19 patients at BMC. The goals of this study are to 1) evaluate differential gene expression between patients who progress to severe disease to those who do not progress, as well as compare patients by race, age, and smoking status; 2) compare NP microbiome composition and diversity between these patient groups; and 3) profile airway or lung specimens with single nucleus RNA sequencing. The information generated in this study will be used to develop predictive biomarkers of COVID disease severity and develop biomarkers for risk, and identify novel targets for treatment.

Autoimmunity, Inflammation, and SARS-CoV-2 Infection

Nahid Bhadelia, MD MALD

February 2021

Survival after SARS-CoV-2 infection appears to be marked by persistence of multisystem symptoms which could constitute a post viral syndrome. This post-acute sequalae of COVID-19 (PASC) - so called "Long COVID" disease - appears to be defined by a range of constitutional, neurocognitive and cardiopulmonary symptoms. Recently, growing evidence suggests that those who have acute infection with SARS-CoV-2 may develop autoimmune antibodies - or immune response - against their own bodies. The objective of this research study is to track the overall immune response as well as evidence of autoimmune antibodies over time of patients who have had a SARS-CoV-2 infection. We hope to understand whether these types of autoimmune antibodies – created during acute infection – last over time, and whether they are correlated with other features of disease and larger immune response.

E25Bio Direct Antigen Rapid Test (DART)

Yachana Kataria, MD

March 2021

This study is a validation of the SARS-CoV-2 Direct Antigen Rapid Test ("DART"), an immunoassay for point-of-care, qualitative detection of SARS-CoV-2 viral particles/secreted protein in nasopharyngeal swabs from suspected patients with COVID-19 infection.

SARS-CoV-2 shedding and re-infection

Manish Sagar, MD

April 2021

The goal of this study is to characterize patients that have been infected with SARS-CoV-2 and have either prolonged virus shedding or re-infection. We propose to examine neutralization capacity and virus characteristics in a cohort of patients with repeat positive RT-PCR test results more than 60 days after an initial positive test, compared to individuals that had a repeat negative test at least 60 days after an initial positive test.

Cultivability and within host evolution of SARS-CoV-2 in persistently PCR positive patients and their relation to host-level factors and nosocomial transmission

Rachel Epstein, MD MA

May 2021

Case series showing immunocompromised individuals with cultivable SARS-CoV-2 virus >20 days from initial symptom onset raise concern that current CDC guidelines on isolation precautions could leave healthcare workers vulnerable. We aim to sequence samples from patients with ongoing PCR positivity and culture a subset with low Ct values. Together, this data will help identify 1) the potential contribution of patients with prolonged PCR positivity to nosocomial transmission clusters, 2) whether patients with prolonged PCR positivity below a given Ct are still infectious, and 3) whether intra-host variability contributes to sequence evolution and corresponds to cultivable virus or ongoing replication.

Virometer: rapid selective detection of respiratory viruses

Scott Schaus, PhD

May 2021

We propose a novel glucometer-based virus test strip that comprises screen-printed electrodes, an aptamer for capturing the virus, and an antibody-glucose oxidase conjugate for signal amplification in the presence of excess glucose. This sandwiched detection assay generates an electrochemical signal and outputs a reading that correlates to the viral copy number present. This study will test the hypothesis that a repurposed glucometer/virus test strip will detect SARS-CoV-2 with a limit of less than 10 virions/mL.

Determining the association of vitamin D-binding protein and bioavailable serum 25-hydroxyvitamin D level with hospital outcomes in patients with COVID-19 infection

Michael Holick, MD

May 2021

A growing amount of evidence suggests that vitamin D status, determined by serum 25-hydoxyvitamin D, is a strong predictor of COVID-19 infectivity, morbidity and mortality. It is possible that the association between vitamin D status and COVID-19 outcomes is mediated by the individual variation of vitamin D-binding protein (DBP), which is mainly determined by certain polymorphisms of the gene GC which encodes DBP. We aim to assess serum levels of 25(OH)D (including bioavailable serum 25(OH)D) and DBP at the time of hospitalization in a cohort of COVID-19 patients and correlate it with hospital morbidity and mortality.