Press Release

Clinical Research Community Continues Consorted Effort to Address COVID-19

News Source: www.clinicalresearchnewsonline.com

As world governments continue to address the spread of SARS-CoV-2 (COVID-19), the clinical research community is looking for ways to manage and treat for the virus as well. Recent efforts include studies related to children infected with the virus, a COVID-19 convalescent plasma study, and much more.

Literature Updates

The number of children infected with the coronavirus is far more extensive than what is currently reported, according to a study by the University of South Florida and the Women's Institute for Independent Social Enquiry. Researchers estimate that for each child who requires intensive care for COVID-19, another 2,381 children are infected with the virus; that translates into a total of 176,264 children in the U.S. infected between March 18 and April 6, although only 74 of them were admitted to pediatric ICUs. Of those admissions, 30% were under 2, 24% ages 2 to 11, and 46% between 12 and 17 years old. If up to 25% of the U.S. population becomes infected with the coronavirus before the end of 2020, 50,000 children with severe illness will need to be hospitalized with 5,400 of them critically ill and requiring mechanical ventilation. Only about 5,100 PICU beds exist in the U.S. The study published in the Journal of Public Health Management and Practice. The authors recommend that state health departments and the Centers for Disease Control and Prevention begin reporting confirmed COVID-19 cases in age-specific tables and make the data publicly available. DOI: 10.1097/PHH.0000000000001190

An exploratory randomized, controlled study in China suggests that neither lopinavir/ritonavir (LPV/r) nor Arbidol improves the clinical outcome of patients hospitalized with mild-to-moderate cases of COVID-19. In some countries, LPV/r is used for HIV-1 infection and Arbidol for influenza. the antivirals had been selected as candidates for treating COVID-19 in a guidance issued in February by the National Health Commission of China, based on in vitro cell tests and previous clinical data from SARS and MERS. The findings published in Med. DOI: 10.1016/j.medj.2020.04.001

Scientists at Duke-NUS Medical School are exploring the engineering of specific virus-targeting receptors onto a patient's own immune cells as a potential therapy for controlling infectious diseases, including COVID-19—an approach classically used in treating cancer. The therapy involves extracting immune cells (T lymphocytes) from a patient's bloodstream and engineering onto them either artificially generated chimeric antigen receptors or T cell receptors that are naturally found on the surface of T lymphocytes. These receptors allow the engineered T lymphocytes to recognize cancerous or virus-infected cells. In a study published in the Journal of Experimental Medicine, researchers demonstrated that T cells can be redirected to target the coronavirus responsible for SARS. They’re now exploring the potential of CAR/TCR T cell immunotherapy for controlling SARS-CoV-2 and protecting patients from its symptomatic effects. DOI: 10.1084/jem.20191663

Researchers at the German Center for Infectious Research (DZIF) say a promising MERS coronavirus vaccine trial in humans may provide useful insights for the development of a vaccine against SARS-CoV-2. In a study just published in Lancet Infectious Diseases, they report that a vector-based vaccine, based on an attenuated virus (MVA: modified vaccinia virus Ankara), boosts immunity against MERS coronaviruses. The vaccine trial was conducted in collaboration with the Clinical Trial Center North and involved 23 healthy trial volunteers who received the experimental vaccine twice. Among the important findings were that the vaccine was well tolerated, no severe side effects occurred and after the second injection antibody formation and T cell responses occurred in 87% of trial subjects. A phase 1b trial will now be conducted with 160 trial subjects in Hamburg and Rotterdam. Results and tests from this trial will be used by DZIF researchers to start the development of a vaccine against COVID-19 where a SARS-CoV-2 spike protein, rather than a MERS-CoV-2 spike protein, gets inserted into the MVA vector. DOI: 10.1016/S1473-3099(20)30317-0

COVID-19 is unlikely to be spread through semen, unlike other emerging pathogens like Ebola and Zika, concludes an international study of 34 Chinese men who were recently diagnosed with a mild to moderate case of the novel coronavirus. No evidence of SARS-CoV-2 was found in the semen or testes of the men, researchers report in Fertility and Sterility. Genes encoding the two proteins associated with SARS-CoV-2 were only found in four of 6,500 testicular cells, suggesting the virus is unlikely to invade human testicular cells. Researchers caution that men who are critically ill with COVID-19 might have a higher viral load that could lead to a greater likelihood of infecting the semen. DOI: 10.1016/j.fertnstert.2020.04.024 

Northwell Health researchers report in JAMA that hypertension (56.6%), obesity (41.7%) and diabetes (33.8%) are the most common comorbidities among 5,700 patients hospitalized with COVID-19 in the New York City area. At triage, 30.7% of patients were febrile, 17.3% had a respiratory rate greater than 24 breaths/minute and 27.8% received supplemental oxygen. The rate of respiratory virus co-infection was 2.1%. Outcomes were assessed for 2,634 patients who were discharged or had died at the study end point. During hospitalization, 14.2% were treated in the intensive care unit care, 12.2% received invasive mechanical ventilation, 3.2% were treated with kidney replacement therapy, and 21% died. Mortality for those requiring mechanical ventilation was 88.1%. DOI: 10.1001/jama.2020.6775

In a systematic review of 18 studies published in JAMA Pediatrics, researchers in Italy report that most children and adolescents with SARS-CoV-2 infection present with fever, dry cough and fatigue or were asymptomatic. Only one infant presented with pneumonia, complicated by shock and kidney failure, and was successfully treated with intensive care. Most pediatric patients were hospitalized, and symptomatic children received mainly supportive care; no deaths were reported in the age range of 0 to 9 years. Recovery within one to two weeks was typical. DOI: 10.1001/jamapediatrics.2020.1467

INOVIO will be working with the International Vaccine Institute (IVI) and the Korea National Institute of Health on an early-phase trial of INOVIO's COVID-19 vaccine candidate (INO-4800) in South Korea. IVI will conduct the trial in parallel with a vaccine study currently underway in the U.S. with 40 healthy adults. Plumbline Life Sciences of South Korea will also collaborate on the project. INOVIO’s DNA vaccine platform was one of the first technologies to receive support from the Coalition for Epidemic Preparedness Innovations to accelerate a COVID-19 vaccine and is providing $6.9 million in grant funding for this trial. It comes at the heels of an announcement by the Korean Ministry of Food and Drug Safety that it will adopt a fast-track approval process for COVID-19 vaccine and treatment clinical trials, shortening the clinical trial screening period from 30 to seven days for substances with experience in use and within 15 days for new materials. INOVIO’s DNA platform also qualifies for an exemption from toxicology tests, which will minimize data submission and expedite clinical trials. Press release

Researchers at McMaster University are taking steps to learn whether the airway microbiome can be harnessed to prevent COVID-19 infections. In one study, they’re trying to identify and isolate the microbes that protect older adults from respiratory infection in collaboration with Mount Sinai Hospital in Toronto. In a second study, they’re trying to tease out the actual infection rate in the city of Hamilton and any differences in the immune responses or airway microbiomes of those who get sick or have symptoms and those who don't. Healthcare workers who become infected with SARS-CoV-2 will be asked to provide a nasal swab of household members to measure the microbiome and a sample of nasal secretions to measure early immune responses. Both studies launched this month. Press release.

Penn Medicine plans to launch a COVID-19 convalescent plasma study, a two-part research initiative that will use the plasma from people who've recovered from the virus to investigate how the therapy works for moderately and severely ill patients. (Read more about the research behind convalescent plasma and other ongoing research projects.) Following approval from the FDA for an Investigational New Drug application, researchers will begin enrolling 50 patients into the first trial clinical trial that will take no more than four months to complete. Each patient will be given up to two units (500 milliliters) of plasma collected at Penn. Press release.

A COVID-19 registry at West Virginia University (WVU) now contains more than 7,500 negative cases and 450 positives from individuals tested through the WVU Medicine system. Updated daily, the registry includes detailed information from patients including testing method, ICU stays, ventilator use, medications, vital signs, pre-existing conditions, labs, procedures and basic demographics. Researchers are provided specific datasets upon approval. Since news of the registry got out, researchers have flooded WVU’s West Virginia Clinical and Translational Science Institute with requests. Some of those projects involve convalescent plasma therapy in patients with severe COVID-19, neurological outcomes in COVID-19 patients and predictive modeling to identify high-risk patients. Press release.
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