Divisional Activities for COVID-19

The Division of Infectious Diseases and Global Public Health is engaging in multiple efforts centering around the SARS-CoV-2 pandemic. A list of research projects and clinical trials is below. If you would like to access more details for these projects, please reach out to the leads directly or contact Mayra V Miller to get viewing access to our online database.

INVESTIGATIONAL EFFORTS  | CLINICAL TRIALS

INVESTIGATIONAL EFFORTS: 

PROJECT
​LEADS
GOALS
FUNDING STATUS
​UCOP Pooled Testing for SARS-CoV-2 to Screen HIV Providers to Protect HIV Patients
Davey Smith (PI) 
Antoine Chaillon (PI)
  • Detect SARS-CoV-2 among asymptomatic care research personnel who are in direct contact with person with HIV (PWH)
  • Protect the staff and PWH who volunteer for research studies from getting infected from an asymptomatic SARS-CoV-2 positive individual​
​Funded
​UCOP Dynamics and Sources of SARS-CoV-2 Shedding to Limit SARS-CoV-2 Transmission
Davey Smith (PI)
Antoine Chaillon (PI)
  • ​Evaluate the duration and level of viral shedding of SARS-CoV-2 in various body fluids of participants with confirmed SARS-CoV-2 infection 
​Funded
​Pooled nucleic acid testing strategies for SARS-CoV-2 infection to protect health care research workers
Antoine Chaillon (PI)
  • Generate preliminary data that will be used for larger grant opportunity to validate an efficient and reliable platform for routine testing of SARS-CoV-2 infection in a workforce setting. If successful, it could be used in other settings to routinely screen the workforce.​
​Funded
​UCOP Forecasting hospital bed resources needed to address the COVID-19 outbreak in California counties
Natasha Martin (PI)
Adriane Wynn
Thomas Martin
  • Model the future hospital bed, intensive care bed, and ventilator needs for COVID at a county level in California​

​Funded
Return to Learn​
​Natasha Martin (Co-PI)
Chip Schooley (Co-PI)
Cheryl Anderson (Co-PI)
  • Program to make SARS-CoV-2 testing available to resident undergraduate and graduate students this summer. The overall goal is to track the virus on campus and ensure early detection, contact tracing, and risk mitigation to better position the campus to resume activities in the fall. 
​Funded
​Ethno-epidemiology of HCV, HIV and Overdose Associated with Drug Markets and Drug Tourism
Steffanie Strathdee (PI)
Antoine Chaillon (Co-I)
Britt Skaathun (Co-I)
Jack Gilbert (Co-I)
Sarah Allard (Co-I)
​Substance users may be at higher risk of acquiring and transmitting SARS-CoV-2 due to their living conditions (e.g. crowded living spaces, homelessness, incarceration) and drug-seeking behaviors (e.g. time spent on the street or in shooting galleries) as well as specific types of substance may damage cilia and lung tissue, which could predispose to SARS-CoV-2 and complications (e.g. secondary bacterial infections). This supplemental study will assess the sample of participants in the new binational cohort of PWID of the parent grant (La Linea) (UCSD IRB # 191390) to address the proposed aims:
  • Aim 1: To determine the prevalence and correlates of subclinical and symptomatic SARS-CoV-2 infection among PWID within the SD/TJ border region.
  • Aim 2: To determine the prevalence and correlates of SARS-CoV-2 shedding in nasal secretions and fecal specimens among PWID.
  • Aim 3: To determine network features associated with cross-border transmission of subclinical SARS-CoV-2 infection among PWID.
  • Aim 4: To use molecular epidemiology to determine the global migration of SARS-CoV-2 between PWID in San Diego and Tijuana and factors associated with local and global dispersal.
​Funded
COVID Clinical Registry and Repository
Eliah Aronoff-Spencer (PI)
Theo Kirkland
Thomas Rogers
Stephen Rawlings
Katya Prakash
TNTC team
  • ​Develop Registry of positive Covid patients (and tested) with clinical factors and data
  • Link to IRB studies 
  • Sample Repository
  • Convalescent serum
​Funded
DiElectric bArrier Discharge LaudrY bin (DEADLY) for COVID-19​
NIWC Team
Timi Adeyemi (PI)
Carlos Flores Molina (Co-I)
Doeg Rodriguez (Co-I)
Kris Buchanan (Co-I)
UCSD Team
Aaron Carlin (PI)
Katherine Promer (Co-I)
Jair Siqueira-Neto (Co-I)
Ryan Maves (Co-I)
  • This collaboration with the NIWC (Naval Information Warfare Center) aims to design and validate a novel device to decontaminate PPE effectively and orders of magnitude faster than currently available options.

​Funded
​Rapid Examination of Collateral Threats to Population Behavioral Health during the COVID19 Pandemic
Alicia Nobles (PI)
  • Assess acute collateral effects for behavioral health, including mental health, substance use, and domestic violence, by examining differential patterns in online help seeking. ​
​Funded
​Measuring Gender Equity and Empowerment for Monitoring and Evaluation: Identifying and Addressing Gaps in the Field
Anita Raj (PI)
  • To identify, develop and test reliable and valid measures of gender equity and empowerment for use in evaluations, large scale surveys as well as for rapid surveys. We have developed Gender Survey Modules for COVID-19 research to assess issues such as sexual exploitation, gender based violence, menstrual hygiene, mental health, social support, and others. ​
​Funded
​Pulmonary Mold Infections in Critically Ill COVID19 Patients in Intensive Care Units - an explorative multinational trial

Martin Hoenigl
Jeff Jenks

  • The primary objective of this study is to determine the prevalence of invasive pulmonary aspergillosis (IPA) in patients with critical COVID19 in intensive care units.
  • Secondary objectives: Determine diagnostic performance of BALF-GM, LFD, LFA for IPA in COVID19; Determine radiological findings on chest imaging in COVID19 patients with and without IPA; Outcome of COVID19 patients on ICU with and without IPA; Length of ICU stay in COVID19 patients with and without IPA; Prognostic potential of plasma and BALF soluble urokinase activator receptor (suPAR) (8), IL-6, and IL-8 in COVID19 patients with and without IPA
​Pending
​Co-infections with COVID-19
Martin Hoenigl
Jeff Jenks 
Sanjay Mehta
  • Identify co-infections in COVID-19 non-invasively
​Pending
​Surveillance, social network spread and control of asymptomatic SARS-CoV-2 Infection among people with and without HIV

Susan Little (PI)
Davey Smith (Co-I)
Britt Skaathun (Co-I)
Annick Bórquez (Co-I)
Tom Rogers (Co-I)

To determine the rate of asymptomatic CoV-2 infection and associated social network spread among persons with and without HIV in San Diego County, we will:
  • Compare the rate of current asymptomatic and past CoV-2 infection and the duration of CoV-2 viral shedding among young adults with and without HIV infection,
  • Determine if the sociodemographic and network features typically associated with HIV risk are also associated with community spread of asymptomatic CoV-2 infection, and 
  • Quantify the contribution of CoV-2 asymptomatically infected persons to incidence among people with and without HIV and identify effective intervention strategies to reduce it, using dynamic modeling informed by network analyses.
​Pending
Rapid Sero-Molecular Surveillance of SD HCW
Becky Colman
Tim Rodwell
  • Establish prevalence of pre/asymptomatic shedders and anti-CV2 seroconversion in HCW in SD County and Community​
​Pending
​Immune Profiling of Moldova TB patients and Close Contacts
​Don Catanzaro
Tim Rodwell
  • Characterize the CV2-specific immune responses in TB pts and close contacts with and without LTBI in Moldova​
​Pending
​POC Dx for COVID-19
​Chris Cooney
Tim Rodwell
  • ​Validate novel COVID assay
​Pending
​POC Ag Test for SARS-CoV-2
​Tim Rodwell
Marva Seifert
Joe Wang
Drew Hall
Tony Catanzaro
  • Develop Novel POC SARS CV2 Ag Detection Test
​Pending
​NOSI supplement to AI131385 (LAST GIFT) Mapping SARS-CoV-2 and Immune Response across the Human Body during COVID-19
Davey Smith (PI)
  • Characterize the molecular determinants and consequences of SARS-CoV-2 virulence across the human body.
​Pending
NOSI supplement to CFAR Pooled Testing for SARS-CoV-2​
Davey Smith (PI)
  • ​Cost-effective screening approach to determine the prevalence of SARS-CoV-2 in the San Diego population.
​Pending
​HSR&D Rapid Response Projects for Time-Sensitive Topics: Pooled Testing for SARS-CoV-2 in Vulnerable Populations
Wang-Rodriguez (PI)

  • ​Develop and validate a secured platform of sample collection and testing for SARS-CoV-2.

​Pending
​PrEP for COVID-19
​Davey Smith
Sanjay Mehta
  • Determine if HCQ is an effective prophylactic agent for COVID-19.​
​Pending
​Modeling UCSD campus reopening strategies
Natasha Martin (PI)
Victor De Gruttola
  • Compare the impact of various housing and classroom enrollment strategies on COVID risk at UCSD
​Pending
​The COPE Study: Capturing Women's Experiences with Mental Health and Violence in Outbreak and Pandemic Environments
Jamila K. Stockman
Katherine M. Anderson
  • Capture violence victimization and perpetration and mental health associated with COVID-19 exposure, prevention efforts, and stressors. ​
​Pending
​Understand T cell and B cell immune responses
Aaron Carlin
Tom Rogers
Stephen Rawlings
Sydney Ramirez
Shane Crotty
Alessandro Sette
Michael Lam
Nicole Coufal
  • Broadly characterize the T and B cell immune responses during the acute and convalescent phases of COVID-19 infection.​

​Developing in vitro models to study SARS-CoV-2 host pathogen interactions
Aaron Carlin
Tom Rogers
Sandra Leibel
Eniko Satji
Xin Sun
Ben Croker
  • ​Develop human relevant in vitro models to study the host-viral interactions contributing COVID-19 disease pathology
Evaluation of SARS-CoV-2 Immunoglobulin for Prevention of Infection in High Risk Situations
John A. Zaia
Michael N. Oxman
Samuel Penziner
Maile Karris
John Guatelli
  • To produce COVID-IG and use it in a large placebo-controlled trial to prevent COVID-19 in healthcare workers and vulnerable patients.

​Repurposed anti-malarial drugs and novel anti-malarial compounds for use in COVID-19 prophylaxis and treatment
Pre-clinical
Elizabeth Winzeler
Tom Rogers
Clinical Trials
Digital Clinical Trials Group
Sara Browne
Constance Benson
Florin Vaida
  • Identify approved agents with in-vitro activity against COVID-19
  • Conduct trials to establish treatment efficacy, dosing and effect of these agents on viral shedding
  • Use as prophylactic agents. Expansion of novel compounds.

Impact of COVID-19 among people living with HIV (PWHIV) in the CNICS cohort: overall and symptomatic incidence, predictors of disease, adverse, clinical outcomes, and mortality 
Edward Cachay
  • Determine the overall and symptomatic incidence and case-fatality rates of PWHIV with COVID-19 
  • Ascertain predictors of adverse clinical outcomes (hospitalization, ICU admission, intubation) and mortality associated with COVID-19 among PWHIV 
  • Assess the proportion of PWHIV who have asymptomatic or minimally symptomatic COVID-19 infection 

Setting: 

  • Cohort analysis using data from The CFAR Network of Integrated Clinical Systems (CNICS) research network across the USA
​​


CLINICAL TRIALS:

CLINICAL TRIAL # AND SHORT TITLE
​INVESTIGATIONAL DRUG
​Open to Enroll
​CO-PIs
PATIENT POPULATION

​MAJOR ELIGIBILITY CRITERIA
​DMID 20-0006: Phase 3 Adaptive Clinical Trial Comparing Safety and Efficacy of Remdesivir vs. Placebo
(IRB 20-0388)
(NCT04280705)
Stage 1
Remdesivir vs. Placebo

Stage 2
Remdesivir vs. Remdesivir + Baricitinib
​Stage 1
Closed

Stage 2
Open
Dan Sweeney
Constance Benson
Sara Browne (Co-I)
Francesca Torriani (Co-I)
​Inpatient moderate to severe
COVID-19 (72 hours)
Radiographic infiltrates
OR 
Clinical symptom (1) SpO2 < 94% on room air,
OR
Requiring supplemental O2,
OR
Requiring mechanical ventilation
ACTG A5395: Phase 2b RCT to Compare Efficacy of Hydroxychloroquine + Azithromycin vs SOC for Mild COVID-19
(IRB 20-0590)
(NCT04358068)
​HCQ +
Azithromycin vs. Placebo

​Approved
Davey Smith
Constance Benson 
​Outpatient 
Mild COVID-19
​Age > 18 yo

Confirmed SARS-CoV-2 within 96h of randomization


At least one COVID-19 symptom

No need for hospitalization

​RAMIC: Phase 3 RCT Safety and Efficacy of Ramipril vs. Placebo
(IRB 20-0624)(NCT04366050)

​Ramipril vs. Placebo
​Yes
Veeral Ajmera
​Inpatient 
or 
Outpatient
Moderate COVID-19
​Age > 18 yo

Confirmed SARS-CoV-2 < 5d pre-entry 

Hospitalized 

SpO2 > 93%

​WA42380: Multicenter RCT to Evaluate Safety and Efficacy of Tocilizumab vs. Placebo
(IRB 20-0491)
(NCT04320615)
​Tocilizumab vs. Placebo
​Closed
Atul Malhotra
Bob Owens
Aaron Carlin
Constance Benson

​Inpatient
COVID-19
Severe

​Hospitalized

Confirmed COVID-19 pneumonia on chest X-ray or CT scan

SpO2 <93% or PaO2/FiO2 < 300 mmHg

Symvivo RCT: Safety, Immunogenicity of bacTRL-Spike Oral Vaccine for Prevention of COVID-19​
(IRB 20-0526)
(NCT04334980)
​bacTRL-Spike oral vaccine

​No
Davey Smith
Susan Little
​Outpatient
Healthy Volunteers
​Age > 18-55 yo
Healthy adults
​Convalescent Serum for Prophylaxis after High Risk Exposure to COVID-19

(IRB 20-0781)(NCT04323800)


​Plasmapheresis of serum from people who recovered from COVID-19 and have IgG antibody
Pending activation
Edward Cachay

Outpatient
Exposed but uninfected participants or HCWs


​Age > 18 years of age

High risk exposure as defined by CDC, to person with COVID-19 within 96 hours of enrollment (and 120 hours of receipt of plasma) AND

Higher risk for severe illness AND/OR

High risk HCW exposure as defined by CDC

Placebo-Controlled Trial of Prevention of SARS-CoV-2 Infection in High-Risk Healthcare Providers​
​Immunoglobulin prepared from pooled plasma from COVID-19 convalescent donors compared to immunoglobulin pooled from donors never infected with SARS-CoV-2 as prophylaxis against SARS-CoV-2 infections.
​No
John Guatelli
Maile Karris
Samuel Penziner
Sonia Jain
Michael Oxman
John Zaia
​Healthcare workers 18 yo and older involved in direct patient care

​Participants will be randomized 1:1 to receive intramuscular injections of COVID-IG or placebo CONTROL -IG every 2 months for 12 months.