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No Clinical Benefit Suggested by Addition of Pulmozyme® to Treatment of Critically Ill Patients With COVID-19 in I-SPY COVID Trial

Today Quantum Leap Healthcare Collaborative (QLHC), sponsor of the I-SPY COVID Trial, announced that the Pulmozyme® (dornase alfa) arm of the trial has been terminated. The interim analysis suggests that the addition of Pulmozyme® to treatment of critically ill patients with COVID-19 is unlikely to achieve statistically significant improvement in efficacy.

SAN FRANCISCO, Jan. 10, 2022 /PRNewswire/ — Today Quantum Leap Healthcare Collaborative (QLHC), sponsor of the I-SPY COVID Trial, announced that the Pulmozyme® (dornase alfa) arm of the trial has been terminated. The interim analysis suggests that the addition of Pulmozyme® to treatment of critically ill patients with COVID-19 is unlikely to achieve statistically significant improvement in efficacy.

The I-SPY COVID Trial was designed to rapidly screen agents that show promise for two primary endpoints: reducing the time to recovery (defined as reduction in oxygen demand) or risk of mortality in critically ill COVID-19 patients. The study utilizes QLHC’s adaptive platform trial design methodology, which focuses on the simultaneous, efficient assessment of multiple investigational agents.

Pulmozyme® was selected for inclusion in the I-SPY COVID Trial because of its potential to break up and clear deleterious neutrophil extracellular traps (NETs) from the lungs of COVID-19 patients and to promote recovery in individuals with COVID-19-related Acute Respiratory Distress Syndrome (ARDS). Previous agents assessed in the trial include cenicriviroc, razuprotafib, apremilast, icatibant, and a combination of famotidine and celecoxib.

There were 125 patients enrolled in the Pulmozyme® trial, and it was administered at 23 participating US sites. The data from the 37 patients who received the Pulmozyme® treatment were compared to those from the 88 patients concurrently randomized to the control arm, which consists of standard of care, including dexamethasone and remdesivir. Patients assigned to the Pulmozyme® arm received the standard of care therapy in combination with Pulmozyme® as a single-use ampule for inhalation as an aerosol mist. After all patients reached 28 days of follow-up, the data suggested there was a low probability that the addition of Pulmozyme® to standard of care therapy significantly impacted time to recovery or mortality. The 37 patients in the Pulmozyme® arm experienced slower recovery than those in the control arm, and there was no statistically significant difference between the two arms. Given these findings, the Data Monitoring Committee (DMC) recommended closing the Pulmozyme® arm of the I-SPY COVID Trial. The study did not identify new safety signals for Pulmozyme® in the setting of critically ill COVID-19 patients.  

Dr. Jon Koff led the study of this agent in the I-SPY COVID Trial: “We demonstrated that Pulmozyme® could be safely administered to critically ill patients with COVID-19. Unfortunately, it did not demonstrate a large improvement in the time to recovery, nor in the reduction in mortality.”

“We are grateful to Genentech and its leadership for supporting the testing of Pulmozyme® in the setting of critically ill COVID-19 patients,” commented Dr. Laura Esserman, co-principal investigator of the I-SPY Trials. “We hope in the near future to have the ability to better segment the critically ill COVID-19 patient population using biomarker subtypes. This effort, led by Dr. Carolyn Calfee at the University of California, San Francisco, and the I-SPY COVID Trial Biomarker Working Group, will hopefully increase our ability to find effective agents for this incredibly challenging and devastating disease.”

Investigation into additional agents via the I-SPY COVID Trial is ongoing and remains an urgent priority for QLHC and its partners. The I-SPY COVID Trial now includes 26 sites as well as leaders in pulmonary and critical care centers from around the country.

The I-SPY COVID Trial is a collaboration between members of QLHC and pharmaceutical partners such as Genentech, a member of the Roche Group, and the United States Government (USG). This work is supported in part by the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, and the Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, in collaboration with the Medical CBRN Defense Consortium. The Defense Threat Reduction Agency enables USG and international partners to counter and deter weapons of mass destruction and emerging threats.

About Quantum Leap Healthcare Collaborative

‍Quantum Leap Healthcare Collaborative is a 501C(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to the I-SPY Trials. For more information, visit www.QuantumLeapHealth.org.

About the I-SPY COVID Trial

‍The I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) is an adaptive platform trial designed to increase trial efficiency by minimizing the number of participants and time required to evaluate experimental and/or repurposed drugs. The focus of the trial is to improve outcomes for severely-ill COVID-19 patients—those who require at least 6L of high-flow oxygen either by mask or nasal cannula, known as level 5 on the World Health Organization (WHO) COVID scale, an 8-point ordinal scale of clinical severity status. The primary endpoints include the time to achieve level 4 or less for at least 48 hours on the WHO COVID scale, a decrease in the duration of time on a ventilator, and a decrease in mortality.

The I-SPY COVID Trial is sponsored and managed by Quantum Leap Healthcare Collaborative. For more information, visit www.quantumleaphealth.org or www.ispytrials.org.

Forward Looking Statements

‍This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the Company files with the SEC available at www.sec.gov.

SOURCE Quantum Leap Healthcare Collaborative

Related Links

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For more information, email karyn.digiorgio@quantumleaphealth.org

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Tracey Heather

Advocate Liaison

As Patient Engagement Lead at Quantum Leap, I manage follow-up data projects for the I-SPY 2 Trial, develop strategies to strengthen patient engagement, and oversee the I-SPY Advocate group. After six successful years raising funds to support Quantum’s mission, I embraced this new role last summer, drawn by the opportunity to make a direct impact on the patients we serve. Each day brings new challenges and insights, and I especially enjoy supporting and collaborating with our inspiring I-SPY Advocates.

Outside of work, I am pursuing a Master of Public Administration with a focus on nonprofit management at SF State. I’m passionate about trail running, skiing, live music, camping, traveling, and collegiate gymnastics—my daughter competes at Oregon State. For the past 5 years, I have volunteered with SF CASA as a mentor to an incredible 18-year-old foster youth whose resilience continually reminds me of life’s true priorities.

Carolyn Clark Beedle

Carolyn Clark Beedle, a 2023 breast cancer survivor, joined the advocate program after successful completion of treatment with the UCSF Breast Oncology Program. Her experience working with a patient advocate during her TNBC treatment led to an understanding that empowering women to advocate for their own health and healthcare will contribute to improved health outcomes and broader access to care. Carolyn began advocating for cancer patients and their families during her treatment, now is a member of the Breast Science Advocacy Core (BSAC) with the UCSF Breast Oncology Program, and currently shares information and research with CFNP associates at La Clinica in the Bay Area to inform and empower their patient population.

Carolyn is continuing her on the ground training as an advocate reviewer with both Quantum Health and BSAC and is enrolled in the Patient Advocacy Training in Health Science course with Stanford Medicine. Her 30+ career in corporate marketing/communications, program development and non-profit leadership augmented by her breast cancer treatment experience serves Carolyn well in representing and communicating the patient voice and perspective.

She received her BA (History/English Lit) and MA (Public History/Research and Record Management) from the University of San Diego, is a proud fifth generation San Franciscan, and active board member with numerous non-profits that support social work and the arts.

Silver Alkhafaji

Silver Alkhafaji is a PhD candidate in the Pharmaceutical Sciences and Pharmacogenomics (PSPG) program at UCSF. She received her Bachelor of Science in Chemical Biology from UC Berkeley. Prior to UCSF, she worked in the Clinical Pharmacology Department at Genentech. Silver’s current research focuses on non-invasive liquid biopsies to predict response and side effects of immunotherapies and endocrine therapies in early-stage breast cancer participants in I-SPY 2.

Silver is interested in clinical outcomes research to advance precision medicine and improve cancer patients’ quality of life. She is passionate about health equity, inclusive research, patient advocacy, and women’s health.
Silver volunteers at the Patient and Family Cancer Support Center at UCSF where she assists in patient navigation and connecting patients and their families with resources that improve their healthcare experience while receiving cancer treatments and/or during survivorship. 

Through her DEI work in her PhD program, Silver raises awareness around issues related to social justice and community building through organizing community-centered events. Additionally, she is a member of the Life Sciences Career Advisory Council at Thrive Scholars, where she enjoys supporting college students of color from economically disadvantaged communities in providing the opportunities they need to thrive at top colleges and in high-trajectory careers. 

Silver is a member of the American Association of University Women (AAUW) Alameda Branch where she focuses her efforts on increasing membership of community college women coming from exceptional backgrounds: student parents, low-income, and first-generation college students.

In her free time, she writes poetry and prose on emotional healing, radical acceptance, and patience. Writing has helped her process difficult situations and connect with people on a deeper level.

Jane Mortimer

Jane is a breast cancer survivor and advocate dedicated to positively impacting the lives of women affected by the disease. Diagnosed with triple negative breast cancer in 2012, she participated in the I-SPY 2 trial at UCSF and has been cancer free for more than ten years.

Her advocacy journey began in 2003 at UCSF as a volunteer with the Patient and Family Cancer Support Center and Decision Support Services and she previously managed the Peer Support program at UCSF. Drawing on her experience in marketing and media strategy, she uses her skills to make a meaningful impact by supporting advocacy and research that improves outcomes for women living with breast cancer.

Jan Tomlinson

In March of 2023 , Jan was diagnosed with a large aggressive triple negative breast cancer and informed that her cancer was the” bad girl” of cancer and offered standard chemotherapy for 24 weeks. Devasted by the diagnosis Jan felt like she had a dire prognosis. After seeking several opinions, she opted to join a Clinical Trial program for her treatment. The trial consisted of significantly less chemotherapy, and monitored closely over a 12-week period, The data predicted a complete pathological response , and she then went immediately to surgery. Pathology reports supported that she had a successful outcome reaching PCR meaning the tumor was gone, and no residual cancer was found in the surrounding tissue or lymph nodes. Jan was thrilled when her surgeon advised her of the results. The experience made Jan want to give back and share information that she received when she was at a critical juncture in her diagnosis. She is so passionate about making sure that everyone knows that the standard of care is one treatment option.

As she says, “ clinical trials have to be on the table” Because she achieved PCR, she expects a great outcome. She wants to share her story and encourage other women to strongly consider and participate in clinical trials. Jan is a UCSF Patient Advocate, involved in several programs they lead. Jan also is a BLACC Cab Member. Jan recently was in Washington DC to participate on a panel on Clinical Trials for ISPY at the National Press Club. UCSF will be hosting the RISE Up For Breast Cancer event where Jan will share her experience with clinical trials.

Deborah Collyar

Deb is a connector who founded Patient Advocates in Research (PAIR) “where research meets reality,” bringing ideas and people together for medical advances that offer real results for diverse patients and families.

Her vast experience between the worlds of tech, communication, strategy, management, policy, and equity bridges gaps between patients, scientists, medical providers, payers, governments, and non-profits.

Deb infuses patient engagement into projects, gathers relevant patient input, and encompasses many diseases, programs and policies at grassroots, national and international levels through companies, academia, and governments.

Key patient insights are delivered throughout discovery, development, clinical trials, results reporting, data-sharing, standards, genomics, and into practice.

Her experience spans translational and clinical research, epidemiology, health outcomes, and health delivery research with academia, federal agencies, companies, and patient communities.