NCI-Supported Clinical Trials for Coronavirus

Clinical trials are research studies that involve people. Through clinical trials, doctors find new ways to improve treatments and the quality of life for people with disease.

NCI supports clinical trials to test promising treatments for patients with coronavirus disease 2019 (COVID-19) and to learn more about the disease's effects on the body. Some of the trials are specifically for patients with cancer. Your doctor can help you decide if a trial is right for you.

Trials 1-25 of 40
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  • A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics (PK) of TAK-981 in Adult Participants With Advanced or Metastatic Solid Tumors or Relapsed / Refractory Hematologic Malignancies and in a Subset With Coronavirus Disease 2019 (COVID-19)

    The primary objective of this study is to determine the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors and lymphomas in Phase 1, to evaluate preliminary efficacy of TAK-981 in participants with select solid tumors or relapsed / refractory CD20-positive (CD20+) non-hodgkin lymphoma (NHL) indications in Phase 2, and to assess change in severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) viral load within 8 days of TAK-981 administration in COVID-19 Expansion.
    Location: 7 locations

  • Best Supportive Care with or without Low Dose Whole Lung Radiation Therapy for the Treatment of COVID-19 Infection

    This phase III trial compares best supportive care combined with low dose whole lung radiation therapy vs. best supportive care alone in treating patients with COVID-19 infection. Low-dose radiation therapy is a type of radiation treatment in which the total dose of radiation is less than that given in standard radiation therapy. The radiation dose used in this study is unlikely to cause short term side effects other than fatigue and temporary low blood cell count. The addition of low dose whole lung radiation therapy to best supportive care may improve patients' clinical status, the radiographic appearance of lungs and / or the laboratory blood tests.
    Location: 3 locations

  • Hydroxychloroquine with or without Azithromycin for the Treatment of COVID-19 Infection

    This phase II trial studies the effect of hydroxychloroquine with or without azithromycin in treating patients with confirmed COVID-19 infection. Hydroxychloroquine is used for the treatment of malaria and autoimmune diseases (lupus, rheumatoid arthritis). Azithromycin is one kind of antibiotic. This trial aims to test whether azithromycin combined with hydroxychloroquine is better than hydroxychloroquine alone for treating patients with symptoms consistent with COVID-19.
    Location: 3 locations

  • A Synthetic MVA-based SARS-CoV-2 Vaccine, COH04S1, for the Prevention of COVID-19 Infection

    This phase I trial evaluates the side effects and best dose of COH04S1, a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by the SARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. COH04S1 was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) into synthetic MVA, which may be able to induce immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The purpose of this study is to determine the safety and the optimal dose of the COH04S1 vaccine.
    Location: City of Hope Comprehensive Cancer Center, Duarte, California

  • Cord Blood-Derived Mesenchymal Stem Cells for the Treatment of COVID-19 Related Acute Respiratory Distress Syndrome

    This phase I trial followed by a phase II randomized trial. The purpose of phase I study is the feasibility of treating patients with acute respiratory distress syndrome (ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stem cells (MSC). The purpose of the phase II trial is to compare the effect of MSC with standard of care in these patients. MSCs are a type of stem cells that can be taken from umbilical cord blood and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs being used for infusion in this trial are collected from healthy, unrelated donors and are stored and grown in a laboratory. Giving MSC infusions may help control the symptoms of COVID-19 related ARDS.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Leflunomide for the Treatment of Severe COVID‐19 in Patients with a Concurrent Malignancy

    This phase I / II trial investigates the best dose and effect of leflunomide (good or bad) in treating patients with COVID-19 and a past or present cancer. Leflunomide has been used since the 1990s as a treatment for rheumatoid arthritis. Laboratory experiments done with human cells infected with severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), the virus causing COVID‐19, showed that leflunomide was able to reduce the ability of the virus to make copies of itself. The coronavirus uses ribonucleic acid (RNA), a very long molecule that contains genetic information that is like a blueprint for making more copies of itself. Leflunomide inhibits the formation of RNA. The information gained from this study may help researchers to learn whether leflunomide is safe for use in treating cancer patients with COVID‐19, and whether it is potentially effective against the disease.
    Location: City of Hope Comprehensive Cancer Center, Duarte, California

  • A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer

    This study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a 2-part study comprising a Phase 1 safety lead-in (Part 1) that will determine the recommended TL-895 dose for Phase 2 (Part 2). In Part 1, TL-895 open-label will be administered orally at an assigned dose continuously in 7-day cycles for 2 cycles. Up to 3 dose levels will be evaluated. In Part 2, eligible subjects will be randomized in a 1:1 ratio to TL-895 with standard available treatment (SAT), or placebo with SAT. Investigators and Sponsor will be blinded to each subject's assigned study intervention throughout the course of the study.
    Location: University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida

  • PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer

    This is a Phase 3 randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pacritinib in hospitalized patients with severe COVID-19 with or without cancer.
    Location: Icahn School of Medicine at Mount Sinai, New York, New York

  • Imatinib for the Treatment of COVID-19 in Hospitalized Adults

    This phase III trial compares imatinib with placebo in treating hospitalized adults with COVID-19 infection. Imatinib is an enzyme inhibitor and may have some antiviral activities. This trial aims to see whether adding imatinib to the best conventional care may help improve outcomes of hospitalized adult patients with COVID-19 infection.
    Location: University of Maryland / Greenebaum Cancer Center, Baltimore, Maryland

  • Rintatolimod and IFN alpha-2b for the Treatment of Mild or Moderate COVID-19 Infection in Cancer Patients

    This phase I / IIa trial studies the best dose and side effects of rintatolimod and interferon (IFN) alpha-2b in treating cancer patients with mild or moderate COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.
    Location: Roswell Park Cancer Institute, Buffalo, New York

  • A Study of N-acetylcysteine in Patients with COVID19 Infection

    This phase II trial identifies the effect of N-acetylcysteine in treating patients who have severe coronavirus disease-2019 (COVID-19) infection that does not respond to treatment (refractory) and are either patients in a critical care unit and / or are connected to a ventilator, or who are not in a critical care unit but require large amounts of supplemental oxygen. Recent studies suggest that the virus that causes COVID-19 may work by suppressing the immune system, which is the body's defense against infections and other diseases. White blood cells called lymphocytes are an important part of this defense, but recently it was found that the number of lymphocytes in a COVID-19 patient’s blood goes down as the infection gets worse and goes up as a patient gets better. N-acetylcysteine has been shown to help increase the number of lymphocytes in the blood when a virus is responsible for lowering it. This trial may help researchers determine whether N-acetylcysteine is effective enough against the virus that causes COVID-19 such that patients could leave the critical care unit or be taken off a ventilator, or could be prevented from needing ventilator support and management in a critical care unit.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Baricitinib, Placebo and Antiviral Therapy for the Treatment of Patients with Moderate and Severe COVID-19

    This phase II trial studies the effect of baricitinib in combination with antiviral therapy for the treatment of patients with moderate or severe coronavirus disease-2019 (COVID-19). Treatment with antiviral medications such as hydroxychloroquine, lopinavir / ritonavir, and / or remdesivir may act against infection caused by the virus responsible for COVID-19. Baricitinib may reduce lung inflammation. Giving baricitinib in combination with antiviral therapy may reduce the risk of the disease from getting worse and may help prevent the need for being placed on a ventilator should the disease worsen compared to antiviral therapy alone.
    Location: 2 locations

  • Anti-IL-8 (BMS-986253) for Hospitalized Patients with COVID-19

    This phase II trial investigates how well BMS-986253 works in treating hospitalized patients with severe COVID-19. COVID-19 is a highly contagious respiratory disease caused by the SARS-CoV-2 virus. The primary causes of death in patients infected with SARS-CoV-2 is acute respiratory distress syndrome, which is primarily a process mediated by molecules promoting inflammation that in turn leads to profound lung injury. BMS-986253 is a human monoclonal antibody against the inflammation promoting mediator called interleukin-8 (IL-8), with potential antineoplastic activities. BMS-986253 may help to improve the outcome of COVID-19 patients.
    Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York

  • The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

    Adults who have tested positive for SARS-CoV-2 infection and who do not require supplemental oxygen will receive PUL-042 Inhalation Solution or placebo 3 times over a one week period in addition to their normal care. Subjects will be be followed and assessed for their clinical status over 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome
    Location: M D Anderson Cancer Center, Houston, Texas

  • A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy and to Treat Systemic Inflammation Associated with COVID-19

    This phase II trial studies how well anakinra works in preventing severe decreased brain function (neurotoxicity), a dangerous condition called cytokine release syndrome (CRS) caused by CAR-T cells, or inflammation associated with COVID-19 infection. T cells (a type of immune cells) are taken from a patient’s blood. Then the gene for a special receptor that binds to a certain protein on the patient’s cancer cells is added in the laboratory. The special receptor is called a chimeric antigen receptor (CAR) and this type of modified T cells are called CAR-T cells. Cytokines are proteins that control body’s inflammatory response. In CRS, a large amount of cytokines is released into the blood, which may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and / or affect the way lungs / liver / kidneys work. CAR-T cell therapy may also cause brain-related symptoms (neurotoxicity), such as dizziness, weakness, confusion, difficulty speaking, and / or possible paralysis, and / or coma. Sometimes the immune system can become overactive in fighting the COVID-19 infection (causing a severe inflammatory reaction), and when a person’s immune system gets out of control that person can become very ill. Anakinra works by blocking the inflammatory cytokine, called IL-1 (interleukin-1) that is released into the blood during or shortly after CAR-T cell therapy or during COVID-19 infection, and causes an inflammatory (swelling) reaction. Anakinra may prevent or reverse the severe side effects of CAR-T cell therapy or COVID-19 infection.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )

    Comparison of the effects of CYT107 vs Placebo administered IM at 10μg / kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients
    Location: M D Anderson Cancer Center, Houston, Texas

  • Ibrutinib for the Treatment of Patients with B-Cell Malignancies Who Are Infected with Coronavirus Disease 2019 (COVID-19)

    This phase II trial studies the effects of ibrutinib in treating patients with B-cell malignancies who are infected with COVID-19. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ibrutinib is a first in class Bruton tyrosine kinase inhibitor (BTKi), for the treatment of B-cell malignancies. This study is being done to determine if taking ibrutinib after contracting COVID-19 will make symptoms better or worse.
    Location: Mayo Clinic in Rochester, Rochester, Minnesota

  • Lopinavir / Ritonavir for the Treatment of COVID-19 Positive Patients with Cancer and Immune Suppression in the Last Year

    This phase II trial studies how well lopinavir / ritonavir works in treating COVID-19 positive patients with cancer and a weakened immune system (immune-suppression) in the last year and have mild or moderate symptoms caused by COVID-19. Lopinavir / ritonavir may help to lessen or prevent COVID-19 symptoms from getting worse in cancer patients.
    Location: OHSU Knight Cancer Institute, Portland, Oregon

  • Ibrutinib for the Treatment of COVID-19 in Patients Requiring Hospitalization

    This phase Ib / II trial studies the side effects and best dose of ibrutinib and how well it works in treating patients with COVID-19 requiring hospitalization. Ibrutinib may help improve COVID-19 symptoms by lessening the inflammatory response in the lungs, while preserving overall immune function. This may reduce the need to be on a ventilator to help with breathing.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • Low-Dose Radiation Therapy for the Treatment of Storming Cytokines and Unchecked Edema in Patients with COVID-19 Infection, RESCUE 1-19 Study

    This phase I / II trial studies how well low-dose radiation therapy works in treating patients with SARS or pneumonia associated with COVID-19 infection. The purpose of this study is to investigate the use of selectively localized low-dose radiation therapy in reducing pulmonary immuno-toxicity (lung damage) within viral pneumonia infiltrates in critically-ill patients with SARS-COVID-19.
    Location: 2 locations

  • Breathing Techniques and Meditation for Health Care Workers During COVID-19 Pandemic

    This phase I trial investigates breathing techniques and meditation for health care workers during COVID-19 pandemic. Yoga is an ancient system of practices used to balance the mind and body through exercise, meditation (focusing thoughts), and control of breathing and emotions. Studies have shown benefit of yoga in healthy volunteers as well as cancer patients. The benefits range from decreasing inflammation to improvement in immune system. Pranayama is a term used to describe breathing techniques that are an integral part of yoga practice. Pranayama and meditation may help manage stress and improve lung health. The goal of this trial is to learn if web-based breathing techniques and meditation help to reduce stress and improve lung health in health care workers dealing with the COVID-19 pandemic.
    Location: M D Anderson Cancer Center, Houston, Texas

  • A Study of Hydroxychloroquine versus Placebo to Prevent COVID-19 Infection in Patients Receiving Radiation Therapy

    This phase II trial studies how well hydroxychloroquine works in preventing infection with the COVID-19 virus in patients receiving radiation therapy. Hydroxychloroquine has been approved for the prevention and treatment of malaria, and the treatment of lupus and rheumatoid arthritis. Receiving radiation therapy may increase the risk of infection with the COVID-19 virus because the patients are in frequent and close contact with healthcare workers and with other patients who may have become infected. Patients receiving treatment for cancer may also have weakened immune system. Giving hydroxychloroquine may help prevent infection with SARS-CoV-2 in patients who are receiving radiation therapy for their cancer.
    Location: 7 locations

  • BCG Vaccine for Health Care Workers as Defense Against COVID 19

    SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.
    Location: M D Anderson Cancer Center, Houston, Texas

  • The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2

    Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19)

    This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.
    Location: 2 locations

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