clinical Archives - Mediarabe

Johnson & Johnson Pauses COVID-19 Vaccine Clinical Trials over Participant’s ‘Unexplained Illness’

October 13, 2020

Johnson & Johnson has paused its late stage clinical trials for a COVID-19 vaccine because of an “unexplained” illness in one of the participants, the company said Monday.

It said in a news release that the trial was paused while the study’s independent Data Safety Monitoring Board conducted a review and evaluation of the participant’s condition.

“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”

The company noted the “significant distinction” between a study pause and a regulatory hold, explaining that a pause is not unexpected in vaccine trials.

“A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol,” the statement said.

Johnson & Johnson’s coronavirus vaccine became the fourth to begin Phase 3 trials in the United States last month and

Johnson & Johnson pauses clinical trials for a COVID vaccine over patient illness

October 13, 2020

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Johnson & Johnson has paused its clinical trials for a COVID-19 vaccine following a patient illness, just weeks after it announced it was in its final stage.

A pause is not entirely unexpected in vaccine trials. When another vaccine trial was temporarily stopped last month, experts hailed the move, pointing to it as an example of the scientific rigor that is being maintained despite the understandably intense public interest for a COVID-19 vaccine.

The Johnson & Johnson trial was paused after an “unexplained” illness in one of its participants and in compliance with regulatory standards, the company said in a news release Monday night. The pharmaceutical company said the patient’s condition was being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board.

“We must respect this participant’s privacy,” the company’s statement said. “We’re also learning more about this participant’s illness, and it’s important to have all the facts

CISCRP To Host Online Health Education Program About Clinical Research on October 22 With Raleigh-Durham Focus

October 10, 2020

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RALEIGH-DURHAM, N.C., Oct. 8, 2020 /PRNewswire-PRWeb/ — The Center for Information and Study on Clinical Research Participation (CISCRP) invites the Raleigh-Durham community to attend AWARE for All, a free online educational health event on Thursday, October 22nd, from 4-6pm EDT via a customized, secure online platform.

CISCRP’s AWARE for All – Raleigh-Durham program is supported by local research teams, advocacy groups, and a consortium of pharmaceutical, biotechnology and service provider organizations. The online program offers organizations the opportunity to bring educational health and clinical research information directly to diverse patient communities and the general public.

Around the world, people are living longer, healthier lives thanks to medical advancements and new treatments and drugs. But that reach could be even greater with increased diversity in clinical research participation. AWARE for All – Raleigh-Durham’s free online program aims to educate and empower the public in making informed decisions about clinical

Rheumatoid arthritis drug cuts coronavirus deaths in clinical trial, Eli Lilly says

October 8, 2020

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Eli Lilly and Company said on Thursday that there were fewer deaths among coronavirus patients who were given a combination therapy involving its rheumatoid arthritis drug and Gilead Sciences Inc’s GILD.O remdesivir drug compared to those who only received remdesivir.

The company has previously shared that the drug, baricitinib, which is marketed as Olumiant, in combination with remdesivir, was shown to cut hospitalization time for coronavirus patients. The findings come from a National Institute of Allergy and Infectious Diseases-sponsored trial dubbed the Adaptive COVID-19 Treatment Trial (ACTT-2).

The company previously shared that the drug, in combination with remdesivir, was shown to cut hospitalization time for coronavirus patients.
(Photo courtesy of Eli Lilly)

In the data shared on Thursday, the company said that the largest benefits were observed in coronavirus patients requiring supplemental oxygen, and those who required high-flow oxygen/non-invasive ventilation.

CORONAVIRUS RECOVERY TIME REDUCED BY RHEUMATOID ARTHRITIS DRUG AND REMDESIVIR,

ASH Releases Clinical Practice Guidelines on the Use of Preventive Anticoagulation in Patients with COVID-19

October 8, 2020

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ASH Releases Clinical Practice Guidelines on the Use of Preventive Anticoagulation in Patients with COVID-19

PR Newswire

WASHINGTON, Oct. 8, 2020

Evidence-based recommendations will inform prevention of COVID-related blood clotting

WASHINGTON, Oct. 8, 2020 /PRNewswire/ — Today, ASH released new guidelines to help clinicians prevent serious blood clotting complications affecting COVID-19 patients. The recommendations suggest that clinicians should use a standard prophylactic anticoagulant dose over higher doses to prevent clotting in patients who have been hospitalized with COVID-19, including those in intensive care.

American Society of Hematology logo.

Abnormal blood clotting has been reported as a complication associated with increased risk of death in patients with COVID-19, particularly hospitalized patients. The guidelines address both critically ill hospitalized patients – people who are ill enough to require intensive care – and acutely ill hospitalized patients – people who require monitoring and treatment in the hospital but not intensive care. It

Clinical Challenges: Managing Hyperkalemia Through Diet

October 8, 2020

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It’s one of the biggest conundrums nephrologists face – how to prevent or treat chronic hyperkalemia by managing diet in patients with chronic kidney disease.

Hyperkalemia is the medical term that describes potassium levels in a patient’s blood that are higher than normal. Hence, the traditional recommendation for managing these with patients is to keep them off foods high in potassium.

The problem, as pointed out by Kamyar Kalantar-Zadeh, MD, MPH, PhD, chief of nephrology, hypertension, and kidney transplantation at the University of California Irvine School of Medicine, is that potassium is critical to the normal functioning of cells, and ensures the proper functioning of nerves and muscles, including the heart. “So potassium is extremely important,” he told MedPage Today, “And it has been shown to lower blood pressure, lower the risk of stroke and heart disease, and increase longevity.”

According to the National Kidney Foundation, a normal amount

UAB begins clinical trial of COVID drug given to Trump

October 7, 2020

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UAB Hospital is recruiting patients for clinical trials of new antibody treatments for COVID-19, including the Regeneron treatment administered to President Donald Trump last week.

The University of Alabama at Birmingham Hospital is helping to develop new techniques to combat the virus that has killed 210,000 Americans and 2,600 in Alabama. UAB is now testing the effectiveness of two new monoclonal antibody drugs and testing convalescent plasma, which is donated from people who have recovered from the virus.

“Our team is excited,” said Dr. Turner Overton, who is leading an outpatient trial for a monoclonal antibody treatment developed by Eli Lilly. “I’m really looking forward to being part of these studies to create a situation where we can have drugs to offer people in the outpatient setting and get our lives back to normal.”

The monoclonal antibody treatments target the spike proteins on the surface of the virus in an

Amfilohije transferred to the Clinical Center in a stable health condition – RegionEnglish

October 7, 2020

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Metropolitan Amfilohije Radovi was transferred to the Clinical Center of Podgorica after it was announced yesterday that he was tested positive for coronavirus

Source: B92 Wednesday, October 7, 2020 | 11:48

SpoonfulOne to Launch Digital Food Allergy Prevention Trial with Duke Clinical Research Institute

October 6, 2020

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MENLO PARK, Calif., Oct. 6, 2020 /PRNewswire/ — SpoonfulOne, a food allergy protection company, is launching a first-of-its-kind digital, randomized, controlled trial with the Duke Clinical Research Institute (DCRI) to evaluate the ability to protect against food allergies with routine feeding of the most common food allergy proteins during infancy and toddlerhood. The trial is expected to begin in December with the recruitment of 1,500 healthy babies between four to six months of age. Study parameters will support new feeding guidelines recommending the early introduction of potential food allergens for food allergy prevention, glean parental experiences of early introduction in infant feeding, and support the evidence showing SpoonfulOne as the category-leading solution for food allergy prevention.

The study will be led by Principal Investigator, pediatric allergist, David Jeong, MD, and co-investigated by DCRI’s Christoph Hornik, MD, PhD, MPH, who specializes in neonatal and infant therapeutics. In addition,

AIM ImmunoTech Announces IRB Approval to Enroll COVID-19 ‘Long Haulers’ in the AMP-511 ME/CFS Clinical Trial of Ampligen

October 6, 2020

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COVID-19 Patients May Continue to Experience Chronic Fatigue-Like Symptoms

Charles Lapp, MD

Charles Lapp, MD, at a recent AIM ImmunoTech Inc. planning meeting on COVID-19-induced chronic fatigue in ‘Long Haulers,’ at the Hunter-Hopkins Center, Charlotte, N.C.

OCALA, Fla., Oct. 06, 2020 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American: AIM) is pleased to announce that it has received Institutional Review Board (IRB) approval for the expansion of the AMP-511 Expanded Access Program (EAP) clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms. Patients in the trial are treated with AIM’s flagship pipeline drug Ampligen.

These patients — commonly referred to as Post-COVID-19 Chronic Fatigue (PCCF) / “Long Haulers” because of the persistence of

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