Compared with hospitalized patients in China, a new study finds higher rates of abnormal liver tests among patients receiving treatment in hospitals in the United States. Higher levels of liver enzymes seem to be associated with an increased risk of admission to intensive care and death.

Researchers at the Yale Liver Center in New Haven, CT, analyzed liver tests from 1,827 patients with COVID-19. All were admitted to Yale-New Haven Health hospitals between March 14 and April 23, 2020.

These tests measure levels of enzymes that the liver releases into the bloodstream when it sustains damage.

An analysis of data from China suggests that around 15% of hospitalized COVID-19 patients had abnormal liver test results. However, 42–67% of the patients in the Yale study had abnormal tests upon admission to the hospital, depending on which of two enzymes the tests measured.

During hospitalization, these figures rose to 62% and 83%, respectively.

The results appear in the journal Hepatology.

Underlying liver disease

The researchers are unsure why the livers of COVID-19 patients in the U.S. are more likely to have sustained damage, but underlying health differences between Chinese and U.S. populations may be responsible.

“We can speculate that U.S. patients may have an increased rate of other risk factors, such as alcoholic or nonalcoholic fatty liver disease,” says senior study author Dr. Joseph Lim, the director of the Yale Viral Hepatitis Program.

Nonalcoholic fatty liver disease (NAFLD) has links to obesity, high blood pressure, diabetes, and high cholesterol levels.

The National Institutes of Health (NIH) estimate that 30–40% of adults in the U.S. have NAFLD. In addition, millions of people have chronic liver infections due to hepatitis B and hepatitis C.

When the researchers looked at the patients’ medical records, they found that around one-quarter of them had abnormal liver tests before contracting SARS-CoV-2.

Regardless of whether they developed liver problems before or after hospitalization with COVID-19, having abnormal test results was associated with worse outcomes from the illness.

After adjusting for other risk factors — including age, sex, body mass index (BMI), and the presence of diabetes — the researchers found that patients with abnormal liver tests were more likely to need intensive care, more likely to require mechanical ventilation, and more likely to die.

The study authors write that this likely reflects direct damage by the virus elsewhere in the body, rather than damage to the liver itself.

Even though liver cells carry the ACE2 receptors that the virus uses to gain entry to cells, the researchers’ analysis suggests that most of the damage is due to inflammation resulting from an infection elsewhere — namely, the bile duct.

A side effect of treatment?

The study also uncovered an association between liver damage and some of the medications that doctors are using to treat COVID-19. This is especially true in the case of a drug called tocilizumab.

“We observed a strong association between the use of COVID-19 medications and abnormal liver tests,” says Dr. Lim.

However, because doctors were more likely to prescribe drugs such as tocilizumab to the most critically ill patients, it was not possible to determine whether the treatment or the disease was responsible for causing liver damage.

The team is conducting further clinical and laboratory-based studies to investigate the effects of COVID-19 on the liver.

They say that more research is necessary to explain why liver damage appears to be so much worse among COVID-19 patients in the U.S. than those in China.

In their paper, the authors acknowledge several limitations of their study. These include its retrospective design and the limited access they had to other demographic and medical information about patients that could have influenced clinical outcomes.

Skepticism, yesterday, greeted the announcement by Russia that it had approved ‘‘world’s first’’ vaccine for COVID-19.

Russia announced the approval after carrying out Phases I and II clinical trials but had yet to conduct the mandatory third phase. The announcement came as the United States of America donated 200 ventilators to Nigeria to boost the fight against COVID-19.

New York Times yesterday reported that the Russian scientific body that developed the vaccine, the Gamaleya Institute, had yet to conduct Phase III tests on tens of thousands of volunteers in highly-controlled trials, a process seen as the only method of ensuring a vaccine is actually safe and effective. Around the world, more than 30 vaccines out of a total of more than 165 under development are now in various stages of human trials.

World Health Organisation maintains a comprehensive list of worldwide vaccine trials. In the latest version of the list, there is no Russian Phase III trial.

President Vladimir Putin of Russia, while making the declaration yesterday, claimed a Russian health-care regulator had become the first in the world to approve a vaccine for coronavirus, though the vaccine had yet to complete clinical trials.

The Moscow pronouncement has, however, raised international concerns, accusing Moscow of cutting corners to score political points.

Medical experts, who spoke with The Guardian yesterday, said the extraordinary pace with which the Russian government approved the vaccine for use was a cause for concern.

They said Phase 3 clinical trial (large study) that should involve thousands of people had yet to be concluded as it only started on June 1. The experts said Phase 3 clinical trial was needed to prove efficacy and safety and would eliminate bias when interpreting results.

Medical experts said they would not recommend the vaccine for Nigeria as it was fast-tracked and also because Russia had not shared or released data concerning the development and studies around the vaccine. They, however, said safety concerns notwithstanding, it showed there was hope that COVID-19 vaccine would be available to Nigerians in the near future.

According to WHO, vaccines should go through three stages of human testing before getting approval for widespread use. The first two phases test the vaccine on relatively small groups of people to find if it will cause harm and if it stimulates the immune system. The last phase, known as Phase 3, compares the vaccine to a placebo in thousands of people.

The final third phase is the only way to know with statistical certainty whether a vaccine prevents an infection. And because it is carried on a much larger group of people, Phase 3 trial can also pick up more subtle side effects of a vaccine that earlier trials could not.

Consultant public health physician/epidemiologist, member of Lagos State COVID-19 Response Team and former chief medical director of Lagos University Teaching Hospital (LUTH), Prof. Akin Osibogun, told The Guardian: “You need first to confirm if a clinical trial was conducted. If one was conducted, there are guidelines under which a clinical trial can be terminated. One condition is when you have obtained evidence that is so overwhelming that it will no longer be ethical to withhold a substance or treatment modality that has been found to be beneficial.

“Some years ago, during the polio vaccine trial, the study was terminated when overwhelming evidence showed its effectiveness. Investigative journalism is required to find out more about what the Russians have done precisely before praising or condemning them.”

A professor of virology, Chairman Expert Review Committee on COVID-19 and pioneer Vice-Chancellor of Redeemer’s University, Oyewale Tomori, said: “A safe and efficacious vaccine is, of course, what we need now. It will be a breakthrough of monumental magnitude. However, what we need now is a breakthrough, not a break loose. Russia says, so far, the vaccine is efficacious and we have no way of confirming that. Until we have that confirmation, it will not be safe to touch the vaccine.”

Tomori, however, said the western press has been sometime unduly critical. “Russia did say she had yet to run the phase three trial and also says mass vaccination will not start until October, so we wait and see. On the issue of rushing the clinical trials, is that not what the others are doing? If Russians are rushing faster than the others, did Yuri Gagarin not get into space before any other person? But the American got to the moon first. So, the issue is not the finishing but successfully completing the processes of clinical trials. Who does that first and shows prove of a safe and efficacious vaccine will win the race,” he said.

Tomori, who is also a consultant with WHO, said safety concerns were many, especially if clinical trial studies were not complete.

“Questions to be answered are: is the vaccine safe, doing no harm and not having or causing adverse effects, especially irreversible adverse effects? Is it efficacious and offers durable protection against the disease,” he asked.

The virologist said many questions could only be answered through clinical trials involving hundreds of people of different age groups and conditions; and this requires appropriate time and adequate number of people.

Tomori said Nigeria should actually participate in these clinical trials but “you know we are not as courageous, preferring not to venture but to consume the remains and leftovers of other courageous people.”

A public health specialist and Executive Director (ED)/Chief Executive Officer (CEO) of the National Primary Health Care Development Agency (NPHCDA), Dr. Faisal Shuaib, told The Guardian any vaccine that had gone through the three phases of clinical trial and obtained licensure would be a welcome development for the COVID-19 pandemic. Shuaib said an approved vaccine would be an unprecedented opportunity to protect the world against the deadly COVID-19.
“It would particularly be of benefit to the most vulnerable and those at highest risk of contracting the virus, like the frontline health workers,” he said.

NPHCDA is in charge of procurement and administering of vaccines in Nigeria, especially against childhood killer diseases.

The epidemiologist emphasized that any vaccine would be tested as stipulated by the National Agency for Food and Drug Administration and Control (NAFDAC). “The COVID-19 vaccine would not be an exception. If anything, we would expect a higher degree of scrutiny to ensure data from the trials unequivocally shows the vaccine is fit for use. Besides that, NPHCDA will collaborate with NAFDAC to ensure the vaccine is safe for use by Nigerians. So we must safeguard the health and interests of Nigerians. This is a priority that is not negotiable,” he said.

Meanwhile, the United States Government has handed over 200 ventilators to Nigeria as promised by President Donald Trump to support the fight against the COVID-19 pandemic.

U.S. also applauded Nigeria for her prompt action to prevent the spread of COVID-19 and urged the country to sustain the effort as an example for other African nations to follow.

While presenting the ventilators to government at the Abuja premier medical warehouse, the U.S. Ambassador to Nigeria, Mary Bert Leonardo, observed that the donation and other assistance by America over the years signified strong cooperation between Nigeria and the United States.

Leonardo noted that since the pandemic began, the United States had provided Nigeria with more than $54 million in COVID-19 assistance and would continue to support Nigeria’s prevention and response efforts, both now and in the future.

Receiving the items, the Minister of Health, Dr. Osagie Ehanire, said the equipment would support Nigeria’s fight against COVID-19.

New research has identified some common factors associated with severe cases of COVID-19 in African American people, including a high body mass index (BMI).

A new study explores some underlying risk factors for severe COVID-19 among African Americans.

The research, published in the journal Obesity, focused on African American people because they are disproportionately affected by the disease, which results from infection with the new coronavirus.

COVID-19 disparities

While all people have a risk of contracting the infection and developing the disease, this risk is not equally distributed.

As the Centers for Disease Control and Prevention (CDC) note, “Long-standing systemic health and social inequities have put many people from racial and ethnic minority groups at increased risk of getting sick and dying from COVID-19.”

Various studies and reviews have demonstrated this disproportionate impact. The articles consistently point to an association between ethnicity and race and COVID-19 severity, highlighting that the disease and our approach to it must be understood in socioeconomic, as well as biological, terms.

As a commentary in the journal BMJ Global Health notes, “Racism, segregation, and inequality, which have been for decades invisibly and pervasively embedded in dominant cultures and social institutions, now emerge as a monumental COVID-19 challenge.”

Even as structural racism requires a wholescale reckoning, understanding the factors beyond systemic inequity that contribute to a high rate of severe COVID-19 among African Americans can help doctors respond effectively.

Dr. Christine Bojanowski, an assistant professor at Tulane University’s School of Medicine, in New Orleans, LA, and the corresponding author of the present study, notes, “It is of tremendous importance that we identify risk factors and those individuals who may be at increased risk for severe COVID-19 infection, so that we are able [to] dedicate efforts toward supporting those most affected and in need.”

“This study is of particular interest in response to emerging reports revealing the disproportionate impact of COVID-19 on the African American community in our country. Further inclusive research aimed at optimizing clinical care relevant to the African American population is critical to ensure an equitable response to COVID-19.”

158 participants

The analysis included African American patients with confirmed COVID-19 who presented to an academic hospital between March 12 and April 9, 2020. In total, the study included 158 participants, 61% of whom were women. The participants’ average age was 57.

The study recorded whether the patients had required treatment in an intensive care unit (ICU), using this to define whether they had experienced severe COVID-19. The participants’ general health was identified retrospectively, by looking at their medical records.

Among the patients with severe COVID-19, 85% required intubation and mechanical ventilation due to respiratory failure.

In total, 37% of the patients receiving ICU care died. However, the actual figure may be higher, as more than one-fifth of the patients were still receiving ventilation in the ICU when the analysis took place.

Obesity, age, and health conditions

The researchers found that the patients who required ICU treatment were typically older, with an average age of 62 years. They also had a higher average BMI: 36.5 vs. 31.9.

In addition, the analysis showed that hypertension and lung disease were predictors of severe COVID-19.

The team notes that obesity is only just beginning to be linked with COVID-19 and recommend that further research explores the association. At the end of June, the CDC updated their guidance to report that anyone with a BMI of 30 or above has a risk of severe disease.

In a commentary on the present study, Dr. Keith C. Ferdinand, a professor of medicine and chair of preventive cardiology at Tulane’s School of Medicine emphasizes that “Instead of stigmatization of black adults with obesity, this pandemic, a hopefully once-in-a-century health crisis, is a clarion call to decrease and eventually eliminate long-standing health disparities and underlying adverse societal structural factors.”