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COVID-19-Related Research and Clinical Trials

Information on Ongoing COVID-19-Related Studies

We are running treatment trials for patients with moderate and severe COVID-19, as well as studies evaluating disease prevention and exposure response methods. We recently treated the first U.S. patient in a multi-site clinical trial of gimsilumab for patients with severe COVID-19 and ARDS.

See the full list below and read more about our current research and clinical trials for COVID-19 patients.

For additional information about COVID-19 clinical trials at Temple, please call 215-707-1359 or email breathe@tuhs.temple.edu.

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Outpatient Clinical Trials

Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting

Investigator: Gerard Criner, MD

The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.

A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness

Investigator: Gerard Criner, MD

The purpose of this study is to measure how well LY3819253, alone or in combination with either LY3832479 (LY-CoV016) or VIR-7831, works against the virus that causes COVID-19.

Inpatient Clinical Trials

Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)

Investigator: Gerard Criner, MD

The purpose of the study is to determine if a high dose of IVIG plus SMT can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the ICU through Day 29.

Immune Modulators for Treating COVID-19 (ACTIV-1 IM)

Investigator: Gerard Criner, MD

The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization.

Anti-thrombotics for Adults Hospitalized With COVID-19 (ACTIV-4)

Investigator: Michael Bromberg, MD, PhD

This is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic strategies for prevention of adverse outcomes in COVID-19 positive inpatients.

CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients

Investigator: Gerard Criner, MD

This is a phase 3, randomized, placebo controlled, double-blind, multicenter, stratified study of CPI-006 plus standard of care (SOC) versus placebo plus SOC in mild to moderately symptomatic hospitalized Covid-19 patients with the primary objective to compare the proportion of participants alive and respiratory failure free between CPI-006 plus SOC versus placebo plus SOC.

Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients

Investigator: Gerard Criner, MD

This Phase 1 single-dose, dose-escalation study is an open label trial evaluating the safety of CPI-006, a humanized monoclonal antibody targeting the CD73 cell-surface ectonucleotidase, as immunotherapy for stable hospitalized mild or moderately symptomatic COVID-19 patients with a parallel non-randomized Control Arm for treatment with standard of care only.

Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)

Investigator: Gerard Criner, MD

The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).

Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease (OSCAR)

Investigator: Gerard Criner, MD

The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to [<=] 48 hours before dosing).

Expanded Access To INOpulse® Inhaled Nitric Oxide Therapy For Patients With Confirmed Or Suspected COVID-19 Who Require Supplemental Oxygen

Investigator: Jeffrey Stewart, MD

The primary objective of this study is to evaluate disease progression in spontaneously breathing COVID-19 patients receiving INOpulse® treatment. This is NOT a clinical trial. Rather, it is an investigational treatment made available through the FDA's Emergency Expanded Access program.

Convalescent Plasma in Outpatients With COVID-19 (C3PO)

Investigator: Nina Gentile, MD

The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration.

RepurpoSing Old Drugs TO SuppRess a Modern Threat: COVID-19 STORM (STORM)

Investigator: Arthur M. Feldman, MD, PhD

The primary aim of this study is to test whether Doxycycline can benefit patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections by inhibiting the replication of the virus while at the same time blocking the development of cytokine storms or inhibiting cytokine-associated coagulopathy respectively.

Vaccine Updates

COVID-19 Vaccine Update and Q&A for Physicians video cover
This presentation provides updates on the latest vaccine-related information and addresses common questions and concerns from physicians at Temple Heath and Fox Chase Cancer Center.
This presentation provides updates on the latest vaccine-related information and addresses common questions and concerns from physicians at Temple Heath and Fox Chase Cancer Center.

View more COVID-19 vaccine Q&A videos from Temple Health and Fox Chase Cancer Center.

Healthcare Worker Exposure Response and Outcomes (HERO) Registry

The HERO Registry is a national clinical research community. It asks healthcare workers across the country to share their experiences, and aims to better understand the impact that the COVID-19 pandemic has on you, your colleagues, family and friends.

The HERO Registry is open to anyone who works in a healthcare setting, including nurses, therapists, physicians, emergency responders, food service workers, environmental service workers, interpreters and transporters.

Learn more and join the registry >