Clinical Trials to Search for COVID-19 Treatments

Clinical researchers are getting trials to patients with COVID-19 faster than ever. Here are the latest Jefferson trials testing potential COVID-19 therapies.

There’s a lot we don’t yet know about the coronavirus that causes COVID-19, although researchers are working on finding out more. We know that some people develop life-threatening disease, while others don’t. In the meantime, clinical researchers are racing to find therapies to help patients survive the disease. Clinical trials are the best way to find out which medicines might work for this disease, and which are not actually effective.

“We all desperately want to find treatments for patients to recover from the disease,” says David Whellan, MD, senior associate provost of clinical research at Jefferson and founder of the Jefferson Clinical Research Institute. “Clinical trials give us a way to find real improvement, not just hope.”

“Our clinical research teams worked incredibly hard to get these trials to patients in record time,” says Dr. Whellan. Many of the drugs fall into one of several types. Some focus on reducing the inflammatory reaction to this virus, which seems to be at the center of some of the worst patient outcomes. Others try to limit viral replication and spread within the body, giving our immune system a chance to catch up to the virus. Many of the therapies have been used for other diseases and conditions, but may also be effective for COVID-19 patients because they target overlapping biological processes.

Learn more about the latest clinical trials at Jefferson for COVID-19 and why researchers think they might work.

1. Convalescent Plasma Treatment

Jefferson is collecting plasma – the clear component of blood that lacks blood cells, but is rich in antibodies – from patients who have recovered from COVID-19. Researchers think that the antibodies from recovered patients might help treat COVID-19 infected-patients. Antibodies work by tagging the virus so it can be swept up by immune cells more easily. They also work by blocking the virus’s ability to enter cells and spread to other organs in the body. Jefferson is uniquely positioned to support this trial with its own blood collection unit, under the direction of Julie Karp, MD, and Alexis Peedin, MD. These doctors along with Kristin Rising, MD, and Anna Marie Chang, MD, developed and implemented the Jefferson donor protocol to collect convalescent plasma.  The plasma is than used in a clinical trial for treatment, led by Mike Baram, MD, and clinical research coordinator Nicole Renzi.  The study aims to test whether the plasma from recovered COVID-19 patients can improve a current COVID-19 patient’s chances of successful recovery by reducing the amount of virus particles in the body. (Listen to ER doctor and researcher Anna Marie Chang’s story of recovery from COVID-19. She talks about how her experience made her want to donate plasma and help to get this clinical trial up and running for other patients.)

To learn more about this trial, go to Clinicaltrials.gov, identifier #NCT04389710

Video: Animated Illustration Explaining Convalescent Plasma and Antibody Testing

Video Made By: Karuna Meda

2. Migraine Therapy for Preventing Inflammation in COVID-19 Patients (Vazegepant)

A Phase 2/3 study, sponsored by Biohaven Pharmaceuticals, will evaluate the safety and efficacy of vazegepant in patients hospitalized at Jefferson with COVID-19 who require supplemental oxygen. Vazegepant is an intranasal spray being investigated for treating acute migraine. However, researchers have reason to believe it may improve outcomes from patients with COVID-19. The drug targets and blocks an enzyme that’s thought to cause inflammation in the brain. The trial will test whether vazegepant can also reduce inflammation in the lungs of COVID-19 patients. The clinical trial is being led by Mike Baram, MD and lead clinical research coordinator, Diana Clarkson.

To learn more about this trial, go to Clinicaltrials.gov, identifier # NCT04346615

3. Putting the Brakes on Inflammation (Tocilizumab)

Inflammation is a hallmark of most infections, and is usually part of a normal and healthy immune response. In COVID-19 disease, however, some research suggests that the inflammatory reaction is too strong and contributes to damage to the lungs and other organ systems. A phase 3 clinical trial sponsored by Genentech at Jefferson will test whether a medicine that blocks inflammation, can potentially treat patients with COVID-19 pneumonia. The drug tocilizumab, is an antibody against a major inflammatory cytokine called IL-6. Researchers think the drug could help reduce the body’s inflammatory reaction to prevent the runaway immune response. The trial is being led at Jefferson by Gautam George, MD, with lead clinical research coordinator, Merrybeth Lynch.

To learn more about this trial, Clinicaltrials.gov identifier # NCT04320615

4. A Multiple Myeloma Drug in Testing for Blocking Coronavirus Growth and Inflammation (selinexor)

A phase 2 clinical trial sponsored by Karyopharm Therapeutics and carried out at Jefferson and other sites will evaluate whether a drug approved for the treatment of the blood cancer multiple myeloma might work in patients with COVID-19. The drug, called selinexor targets exportin 1 (XPO1), a protein involved in moving cargo out of the cell’s nucleus into the cytoplasm. This nuclear export process is both important for driving inflammation and also for the virus’s ability to replicated thousands of copies of itself within the cell. In preliminary laboratory experiments, selinexor reduced both inflammation and the virus’s ability to replicate within the cell. The clinical trial, led by Ross Summer, MD, and clinical research coordinator, Merrybeth Lynch at Jefferson, will test whether the observations in the lab translate to improvement in patients with COVID-19.

To learn more about this trial, go to Clinicaltrials.gov, identifier: NCT04349098

5. A Drug for Stem Cell Transplantations Tested for COVID-19 (CD24Fc)

In some cases of viral infection, our own immune system does more damage to our own cells, in an attempt to get rid of the virus, than the virus itself. Taking learning from a similar situation, researchers are testing a drug used to treat bone marrow transplant patients. Bone marrow transplantation patients are treated with immune-suppressing drugs to keep the new bone marrow cells, which make up the immune system, from attacking the patient’s body. The phase 3 clinical trial sponsored by OncoImmune, Inc., will test whether the drug CD24Fc can help reduce inflammation and prevent organ failure in COVID-19 patients. The drug may do this in part by dampening the immune overreaction, and also rescuing T cells from exhaustion and elimination. T-cell exhaustion is something clinicians have observed in worst-case patients with COVID-19. The study is being led by Mike Baram, MD, and clinical research coordinator Elizabeth Duddy.

To learn more about this trial, go to Clinicaltrials.gov, identifier: NCT04317040

6. Vitamin C infusion

While later stages of COVID-19 disease are caused by an overactive immune response, there is a need for the immune system to fight the disease in earlier stages.  Vitamin C infusion have shown to increase the activity and activation of some immune cells, which are a crucial component of the body’s defense against viral disease progression. Dagan Coppock, MD, will lead a phase 1 clinical trial testing whether vitamin C, or ascorbic acid, infused via intravenous is safe and effective in patients suspected of COVID-19. The study will enroll patients who require supplemental oxygen, but are unlikely to require a ventilator within 48 hours of being admitted to the hospital for COVID-19. The lead clinical research coordinator for the trial is Bret Mullin.

To learn more about this trial, go to Clinicaltrials.gov, identifier: NCT04363216

7. Defining Characteristics of Severe Disease

Dysregulation of immune responses and alterations of peripheral lymphocyte subsets are hallmarks of severe COVID-19 infection. Non-survivors are more likely to have low lymphocyte counts and high pro-inflammatory cytokine signatures. However, how these changes develop overtime and drive progression in early stages of disease is largely unknown. In order to understand the changes in the immune system of severe COVID-19 disease, Neda Nikbakht, MD, PhD, will collect serial blood samples from COVID-19 patients treated at Jefferson for analysis.

8. Testing a Drug with Antibiotic, Antifungal, and Anti-inflammatory Properties  (Sirolimus)

The drug sirolimus, also called rapamycin, is known for its anti-inflammatory properties and used as a medicine to prevent organ rejection after transplants, and used to coat stents. The drug also has antibiotic and antifungal properties. These unique characteristics make it a candidate therapy for COVID-19. The phase 1 clinical trial will test whether the drug is safe and effective in patients, and is being led by Walter Kraft.

To learn more about this trial, go to Clinicaltrials.gov, identifier: NCT04371640

9. COVID-19 in Cancer Patients

The National Cancer Institute is partnering with institutions across the country, including Jefferson, to study patients with COVID-19 and cancer. The NCI COVID-19 in Cancer Patients Study (NCCAPS) clinical trial is observational. Its goal is to learn how the two diseases change over time and interact with each other in order to find better ways to treat and care for patients with these two overlapping disease. No new drug will be tested during this trial; however, data about a patient’s treatment will be collected, along with blood samples. The grant for this work was awarded to Edith Mitchell, MD, Director, Center to Eliminate Cancer Disparities and Associate Director of Diversity Affairs in the Sidney Kimmel Cancer Center – Jefferson Health; the clinical trial will be led by Jefferson medical oncologist Babar Bashir, MD.

To learn more about this trial, go to Clinicaltrials.gov, identifier: NCT04387656

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