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 Rodriguez to get viewing access to our online database. (Last updated on: 06/07/2021)

INVESTIGATIONAL EFFORTS  | CLINICAL TRIALS

INVESTIGATIONAL EFFORTS: 

PROJECT
​LEADS
GOALS
FUNDING STATUS
​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
​Proyecto EPICO
Steffanie Strathdee
Constance Benson
Richard Garfein
Ietza Bojorquez (COLEF)
Jaime Sepulveda (UCSF)
​To determine the prevalence and correlates of SARS-CoV-2, HIV and TB infections among migrants to Tijuana
​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
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
​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
​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. 
​Funded
​Safer At School Early Alert for K-12 Schools (SASEA)
Rebecca Fielding-Miller (PI)
Rob Knight (Co-PI)
Gene Yeo (Co-I)
Louise Laurent (Co-I)
Laura Kohn (Co-I)
Natasha Martin (Consult)
Richard Garfein (Consult)
Tommi Gaines (Consult)
Borsika Rabin (Consult)
  • Determine the validity, reliability, and sensitivity of alternative monitoring and testing strategies for K-12 sites.
  • Determine potential real-world effectiveness of a wastewater early alert system for K-12 sites.
  • Develop best-practice implementation protocols to ensure long-term project sustainability using an implementation science framework and consulting stakeholders at the county, district, and individual school level.  ​
​Funded
​Impact of COVID-19 on tuberculosis services in migrant population from Baja California, Mexico
​Richard Garfein (US PI) 
Raquel Muñiz-Salazar (Mexico PI)
  • ​To describe the impact of COVID-19 outbreak on the performance of the Mexican National Tuberculosis Program on migrant populations in Baja California.
Funded
​Baja California, Mexico COVID-19 Surveillance Study
Linda Hill (US PI)
Oscar Efren Zazueta (Mexico PI)
Ietza Bojorquez (Co-I)
Richard Garfein (Co-I)
Timothy Rodwell (Co-I)
Steffanie Strathdee (Co-I)
Lucy Horton (Co-I)
Rene Machado (Mexico Co-I)
Manuel Sanchez Alavez (Mexico Co-I)
Raquel Muñiz-Salazar (Mexico Co-I)
  • To estimate ​the prevalence and incidence of COVID-19 in the three major cities in Baja California, Mexico (Tijuana, Mexicali and Ensenada).
  • Describe the knowledge, attitudes, and practices around COVID-19 among minors and adults living in Baja California.
​Funded
​Project 2VIDA!
​Argentina Servin (PI)
Davey Smith (Co-I)
Jamila Stockman (Co-I)
Britt Skaathun (Co-I)
Fatima Muñoz (Co-I)
Gregory Talavera (Co-I)
As of January 2021, the World Health Organization (WHO) reports that 89 million cases of COVID-19 (SARS-CoV-2) have been confirmed and have resulted in more than 1.9 million deaths globally. Currently, the United States (U.S.) is the country with the largest number of infections and deaths due to COVID-19, with a total of 22 million infections and 373,167 deaths. Furthermore, early findings that have examined COVID-19 demographics show that racial and ethnic minorities in the U.S. are bearing a disproportionate number of COVID-19 cases and deaths irrespective of geographic region. Project 2VIDA! (SARS-CoV-2 Vaccine Intervention Delivery for Adults in Southern California), is a multilevel intervention to address individual, social, and contextual factors related to access to, and acceptance of, the COVID-19 vaccine among Latinx and AA adults (> 18 years old) across six highly affected communities in Southeast San Diego. 2VIDA! seeks to implement and assess a COVID-19 vaccination protocol to increase interest and uptake of COVID-19 vaccine, provide COVID-19 vaccines in the community, and establish a model for the rapid vaccination of Latinx and AA adults that could be generalized to other highly affected communities. 
​Funded

CLINICAL TRIALS:
Approved/Enrolling

CLINICAL TRIAL # AND SHORT TITLE
​INVESTIGATIONAL DRUG
​OPEN ENROLLING
​CO-PIs
PATIENT POPULATION

​MAJOR ELIGIBILITY CRITERIA
Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis (ISAVU-CAPA)
IRB # 200639
NCT04707703
​Isavuconazole vs. Placebo
​Yes
​PI: Jenks
Sub-I: Hoenigl
​Inpatients with severe COVID requiring ICU admission
  • ​​Age  > 18 years
  • Confirmed SARS-CoV-2
  • Hospitalized in the ICU
  • On non-invasive ventilation and receiving dexamethasone or on invasive mechanical ventilation or ECMO
DMID 20-0006: Phase 3 Adaptive Clinical Trial Comparing Safety and Efficacy of Remdesivir vs. Remdesivir + IFN-beta-1 (ACTT-3)
(Version 7, Aug20)
(NCT04280705)
Stage 3-ACTT3
Remdesivir + Placebo vs. Remdesivir + IFN-beta-1
Stage 3
Open Aug 17
Sweeney
Benson
​Inpatient moderate to severe
COVID-19 (72 hours)
  • ​Age >18 yo
  • Confirmed SARS-CoV-2
  • Hospitalized
  • SpO2< 93%
RAMIC: Phase 3 RCT Safety and Efficacy of Ramipril vs. Placebo
(IRB 20-0624)
Amendment 1 (25April20)
(NCT04366050)
Ramipril vs. Placebo​
​Yes
​​Loomba 
Inpatient
or 
Outpatient

Moderate COVID-19
  • ​Age > 18 yo
  • Confirmed SARS-CoV-2 < 5d pre-entry 
  • Hospitalized
  • SpO2 > 93%
Convalescent Plasma for Prophylaxis after High Risk Exposure to COVID-19
(IRB 20-0781)
(Version 28Apr20)
(NCT04323800)

Plasmapheresis of serum from people who recovered from COVID-19 and have IgG neutralizing antibody to SARS-CoV-2
Pending
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
ACTIV-2/A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (ADAPT OUT)
Phase 2/3
Adaptive Clinical Trial 

LY-3819253 monoclonal antibody vs. Placebo

​Pending

Smith
Benson

Outpatients with confirmed mild-moderate COVID-19


  • Age > 18 yo
  • Confirmed SARS-CoV-2 < 7d pre-entry;
  • At least one COVID-19 symptom;
  • Not requiring hospitalization


COVID-PACT: Prevention of Arteriovenous Thrombotic Events in Critically Ill COVID-19 Patients

Full dose vs standard anticoagulation prophylaxis vs antiplatelet vs no antiplatelet therapy for prevention of venous and arterial thrombotic events
(Study drugs-Heparin, Enoxaparin, Clopidrogel)

​Pending
Fernandez
Morris
Patients with severe COVID-19 requiring ICU admission without an indication for full dose anticoagulation
  • Age > 18
  • Acute SARS-CoV-2 infection confirmed
  • Admitted to ICU


CLINICAL TRIALS:
Completed

​CLINICAL TRIAL # AND SHORT TITLE
​INVESTIGATIONAL DRUG
​OPEN ENROLLING
​CO-PIs
PATIENT POPULATION ​​MAJOR ELIGIBILITY CRITERIA
WA42380: Multicenter RCT to Evaluate Safety and Efficacy of Tocilizumab vs. Placebo
(IRB 20-0491)
(Version 2, 14Apr20)
(NCT04320615)

​Tocilizumab vs. Placebo
​Closed
Malhotra
Owens
Carlin
Benson
​Inpatient
COVID-19
Severe
  • Hospitalized; confirmed COVID-19 pneumonia on chest X-ray or CT scan
  • SpO2 <93% or PaO2/FiO2 < 300 mmHg
​mRNA-1273-P301/CoVPN 3001: Phase 3 Randomized, Stratified, Observer-Blind, Placebo-Controlled Trial of mRNA-1273 SARS-CoV-2 Vaccine for Prevention of COVID-19
​mRNA-1273 encoding the spike protein of SARS-CoV-2 formulated in lipid nanoparticles 2 IM doses one on day 1 and one on day 29 
​Yes
​Spector
Outpatient
Healthy Adults​

  • ​Age > 18 yo
  • Healthy adults or who have medically-stable chronic diseases and are at increased risk for SARS-CoV-2 acquisition and serious Covid-19 disease
​AD1222/CoVPN 3002: Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter study of AZD1222, a Non-Replicating ChAdOx1 Vector Vaccine for the Prevention of COVID-19
​AZD1222 non-replicating ChAdOx1 chimpanzee adenovirus vector vaccine targeting SARS-CoV-2 spike protein 
​No
​Little
​Outpatient healthy adults
(Sub-site in El Centro)
  • ​Age > 18 yo
  • Healthy adults or who have medically-stable chronic diseases and are at increased risk for SARS-CoV-2 acquisition and serious Covid-19 disease
VAC31518/COV3001/JNJ-78436735
Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19
Human replication-incompetent adenovirus (Ad26) vector encoding the SARS-CoV-2 spike protein​
​No
​Little
​Outpatient healty adults
  • ​Two stages of enrollment; Stages 1a and 1b will include healthy adults at least 18 to 59 yo; Stage 2a and 2b will enroll healthy adults >60 yo. Stages 1b and 2b will include adults with and without medically-stable chronic diseases.

 

CLINICAL TRIALS:
Pending Vaccine Trials

​CLINICAL TRIAL # AND SHORT TITLE
​INVESTIGATIONAL DRUG
​OPEN ENROLLING
​CO-PIs
​PATIENT POPULATION
​MAJOR ELIGIBILITY CRITERIA
​Symvivo RCT: Safety, Immunogenicity of bacTRL-Spike Oral Vaccine for Prevention of COVID-19
(IRB 20-0526)
(Version 15Apr20)
(NCT04334980)
​bacTRL-Spike oral vaccine 
​No
Smith
Little
​Outpatient
Healthy Volunteers
  • ​Age > 18-55 yo
  • Healthy adults