COVID-19 Updates

Visit UC San Diego's Coronavirus portal for the latest information for the campus community.

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-Miller to get viewing access to our online database. (Last updated on: 11/9/2020)

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
​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
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
​The COVID-19 Prevention Trials Network (COVPN) - will support late-stage clinical trials of promising vaccines and monoclonal antibodies.
Susan Little (Local PI)
  • Will vary by study; will prioritize communities most vulnerable to COVID-19's severe outcomes. ​
​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

CLINICAL TRIALS:
Approved/Enrolling

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

​MAJOR ELIGIBILITY CRITERIA
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
C3PO Convalescent Plasma for Treatment of Mild-Moderate COVID-19 Disease
​Plasmapheresis of serum from people who recovered from COVID-19 and have high IgG neutralizing antibody to SARS-CoV-2
​Pending
​Coyne
​ED and outpatient participants with confirmed mild-moderate COVID-19 
  • Confirmed SARS-CoV-2 infection
  • Not requiring hospitalization
  • Deemed stable for outpatient management without new supplemental O2 requirement
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

UNITE Study for Covid-19: Ultrasound Neural and Immunomodulation Treatment Evaluation Study


Randomized evaluation of SecondWave MINI system splenic ultrasound on modulating the immune response, reduce cytokine storm, reduce lung inflammation
Pending
Lerman
Malhotra
Bhardwaj

Hospitalized Patients with documented Covid-19 requiring supplemental O2


  • No age requirement
  • Acute SARS-CoV-2 infection confirmed
  • Hospitalized




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
DMID 20-0006: Phase 3 Adaptive Clinical Trial Comparing Safety and Efficacy of Remdesivir vs. Placebo
(IRB 20-0388)
(Version 6, 2Jun20)
(NCT04280705)
​Stage 1-ACTT1 Remdesivir vs. Placebo
​Stage 1 Completed
Sweeney
Benson
​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
​DMID 20-0006: Phase 3 Adaptive Clinical Trial Comparing Safety and Efficacy of Remdesivir vs. Remdesivir + Baricitinib
(IRB 20-0388)
(Version 6, 2Jun20)
(NCT04280705)

​Stage 2-ACTT2 Remdesivir vs. Remdesivir + Baricitinib
​Stage 2 Completed
Sweeney
Benson
​Inpatient moderate to severe COVID-19 (72 hours)
  • ​Same as above
ACTG A5395: Phase 2b RCT to Compare Efficacy of Hydroxychloroquine + Azithromycin vs SOC for Mild COVID-19
(IRB 20-0590)
(Version 13Apr20)
(NCT04358068)
​HCQ + Azithromycin vs. Placebo
​Closed early based on other trials showing no effect of HCQ for Rx or prevention
Smith
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
​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