CIL Involved Trials

Study Name Description
Adaptive COVID-19 Treatment Trial (ACTT)

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

"This study served as an evaluation of remdesivir, and investigational broad-spectrum antiviral treatment developed by Gilead Sciences, Inc. Enrollment for this trial closed on April 19 after recruiting 1,063 participants at 47 U.S. and 21 international sites. An independent data and safety monitoring board (DSMB) overseeing the trial met on April 27 and shared their preliminary analysis with the study sponsor, NIAID. Their analysis showed that patients who received remdesivir had a statistically significant shorter time to recover compared to patients who received placebo." (NIH)

CIL contributed to this study by processing and accessioning samples of whole blood for plasma, SST, and swabs for qualitative and quantitative virologic assessments.

Adaptive COVID-19 Treatment Trial 2 (ACTT-2)

ACTT-II examines if adding an anti-inflammatory agent to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes. In this trial, all participants will receive either remdesivir or remdesivir with baricitinib. 

Barcitinib is a product licensed to Eli Lilly and Company by Incyte and marketed under the name Olumiant. It is approved in the U.S. and in more than 65 additional countries as treatment for adults with moderately to severely active rheumatoid arthritis. Some people with COVID-19 experience acute respiratory distress syndrome (ARDS), in which inflammation of the lungs leads to shortness of breath and rapid breathing. Baricitinib, taken orally, inhibits cytokine signaling in the body that play roles in causing inflammatory responses. The putative benefit of baricitinib for COVID-19 has been described in a case series of critically ill patients who recovered from COVID-19. The combination of remdesivir and baricitinib for COVID-19 has not been evaluated in a large, randomized controlled treatment trial. 

CIL contributed to this study by processing and accessioning samples of whole blood for plasma, SST, and swabs for qualitative and quantitative virologic assessments.

Adaptive COVID-19 Treatment Trial 3
(ACTT-3)

ACTT-3 will evaluate the combination of interferon beta-1a and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.

CIL contributed to this study by processing and accessioning samples of whole blood for plasma, SST, and swabs for qualitative and quantitative virologic assessments.

Adaptive COVID-19 Treatment Trial 4
(ACTT-4)

ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29.

CIL contributed to this study by processing and accessioning samples of whole blood for plasma, SST, and swabs for qualitative and quantitative virologic assessments.

COVID-19 Host Immune Response Pathogenesis (CHIRP)

The purpose of this study is to find out why the severity of symptoms of individuals with COVID-19 varies greatly from those who are asymptomatic to those who are severely affected. Potentially, this information could be applied to develop vaccines, treatment, and better testing for COVID-19. Factors being considered for analytics are related to an individual's genetics, immune defenses, and personal characteristics (e.g. gender, age, medical conditions, personal habits (i.e. smoking, etc.))

CIL contributes to this study by processing and accessioning samples of whole blood for plasma/PBMCs, SST, stool, urine, and swabs. Select samples are used in-lab for CyTOF assay work or shipped out of house for serologic assay work and qualitative and quantitative virologic assessment.

DISulfiram for COvid-19
(DISCO

Disulfiram (DSF) a safe, easily dosed, FDA-approved drug for the treatment of alcohol dependence has been identified to be a potential therapeutic target for SARS-CoV-2 infection. Disulfiram may have both antiviral (inhibiting viral replication via blocking the Mpro protease and zinc ejection) and anti-inflammatory effects (via inhibition of NF-kB-induced and NLRP inflammasome-induced cytokine release) on SARS-CoV-2. We will study oral disulfiram given for 5 consecutive days (1000 mg/day in cohort 1; 2000 mg/day in cohort 2) in 60 symptomatic COVID+ individuals in a randomized (2:1) randomized, double blind placebo-controlled trial evaluating disulfiram's effect on COVID-19 symptom severity, SARS-CoV-2 viral load, and biomarkers of inflammation and pyroptosis (aberrant pro-inflammatory cell death) over 31 days.

CIL contributes to this study by processing and accessioning samples of whole blood for plasma/PBMCs, SST, stool, urine, and swabs. Select samples are used in-lab for CyTOF assay work or shipped out of house for serologic assay work and qualitative and quantitative virologic assessment.

COVID-19 Multi-Phenotyping for Effective Therapies (COMET)

COMET is an NIAID-funded multi-institutional study to collect detailed clinical, laboratory, and radiographic data in coordination with biologic sampling of blood and respiratory secretions and viral shedding in nasal secretions in order to identify immunophenotypic features of COVID-19 -related susceptibility and/or progression in order to generate hypotheses for effective host-directed therapeutic interventions.

To accommodate the biosafety hazards related to specimen from this study, we retrofitted a BSL2* facility to process COVID-19 tracheal aspirates collected at ZSFG for 10x single cell genomics and CyTOF staining. In addition to this we processed and stored whole blood EDTA, whole blood SST, and swab samples.

Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC)

 

This surveillance study will collect detailed clinical, laboratory, and radiographic data in coordination with biologic sampling of blood and respiratory secretions and viral shedding in nasal secretions in order to identify immunophenotypic and genomic features of COVID-19 -related susceptibility and/or progression. The aim: for the results obtained from this study to assist in generating hypotheses for effective host-directed therapeutic interventions, to help to prioritize proposals for such interventions, and/or optimize timing for administration of host-response directed therapeutics.

COMET is a substudy of the IMPACC cohort. To accomodate the biosafety hazards related to specimen from this study, we retrofitted a BSL2* facility to process COVID-19 tracheal aspirates collected at ZSFG for CyTOF staining. In addition to this we process and store whole blood EDTA, whole blood SST, and swab samples.

Mesenchynal Stromal Cells for Acute Respiratory Distress Syndrome (STAT)

STAT is a clinical trial looking at the effects of a 1 time infusion of mesenchymal stem cells into patients with Acute Respiratory Distress Syndrome (ARDS). Initially the study was being done in patients showing ARDS from a variety of issues, many of whom are also compromised with SARS-CoV-2. The study has shifted to enrolling these patients to see whether the treatment helps in severe cases. 

CIL processes whole blood and urine specimen for qualitative and quantitative virological analysis.

A5395

This trial is a randomized, double-blind placebo-controlled trial to evaluate the efficacy of Hydroxychloroquine and Azithromycin to prevent hospitalization or death in persons with COVID-19. This study's purpose is to see if hydroxychloroquine (HCQ) and azithromycin (Azithro) treatment will prevent hospitalization and death in adults with COVID-19.

CIL processes whole blood specimen, SST, and swabs for qualitative and quantitative virological analysis. 

A5396

This trial is to evaluate the efficacy of Hydroxycholorquine and Azithoromycin in hospitalized COVID-19 patients in collaboration with Novartis.

Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants with COVID-19-induced Pneumonia (CAN-COVID)

This trial is to evaluate the efficacy of Canakinamab in hospitalized COVID-19 patients in collaboration with Novartis. This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab plus standard-of-care (SOC) compared with placebo plus SOC in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS)

CIL processes and stores whole blood EDTA for plasma, SST serum, DNA, and OP Swabs for qualitative and quantitative virological analysis.

Long-term Impact of Infection with Novel Coronavirus (LIINC)

The LIINC study is a collaboration of researches looking for adult volunteers who tested positive for COVID-19. Our team is working to understand the changes that happen in the immune system after recovery from the virus. LIINC is a team effort that connects researchers across UCSF and the U.S. with the goal of understanding the immune response to the virus and how it affects a person's body during recovery - this includes its effects on the heart, lungs, and brain. Study visits include a questionnaire, a blood test, and a saliva test. 

CIL contributes to this study by processing and accessioning samples of whole blood, saliva, and dried blood spots for qualitative and quantitative virologic assessments.

Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients (CAPRI)

The purpose of the CAPRI study is to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms. 

CIL contributes to this study by processing and accessioning samples of whole blood for plasma, SST, DNA, and swabs for SARS-CoV-2 viral load assessments. 

Community Project: Mission District COVID-19 Testing

Mass testing of residents and workers in the Mission District census tract who were tested in late April for active infection with the novel coronavirus was conducted as a community-led screening project, led by Unidos en Salud. UCSF researchers partnered with the organization, Mission community organizers in the Latino Task Force for COVID-19, and SFDPH to inform and mobilize a population that was not being reached by current testing and care systems. 

The project's goal was to determine active and prior COVID-19 infections by providing voluntary testing for all persons in Mission District census tract 022901, regardless of symptoms. It also is evaluating a novel-community-based "test to care" program that will provide extensive follow-up support to those who test positive for the virus.

Lab member, Jordan, volunteered his services to be a part of the team that pipetted serum from over 4000 microtainer samples in support of the Unidos en Salud testing. 

Click the link to see the initial results of the Mission District COVID-19 Testing.


Disclaimer: This online resource does not provide medical advice and is intended for informational purposes only. It is not a substitute for professional medical advice, diagnosis or treatment. This information should never replace professional medical advice or replace seeking treatment with a certified care provider.