UK trial finds no benefit from azithromycin in hospital COVID-19 patients
Investigators with the United Kingdom’s RECOVERY trial reported yesterday that a preliminary analysis of data from the azithromycin arm of the trial showed the antibiotic had no impact on clinical outcomes in hospitalized COVID-19 patients.
In the trial, which was conducted among COVID-19 patients at 176 National Health Service hospitals, 2,582 patients were randomized to receive 500 milligrams of azithromycin, an antibiotic, once daily and compared with 5,182 patients who received usual care. Patients entered the study an average of 8 days after onset of symptoms. The primary outcome was 28-day mortality, and the results, which were not peer-reviewed, were published on medRxiv, a preprint server.
Preliminary analysis of the data showed that 496 patients who received azithromycin (19%) and 997 patients allocated to usual care (19%) died within 28 days (rate ratio, 1.00; 95% confidence interval, 0.90 to 1.12; P = 0.99). Investigators also found no evidence of beneficial effects on the risk to progression to mechanical ventilation or length of hospital stay.
Azithromycin is one of several treatments for COVID-19 being tested in the RECOVERY trial, under the theory that it could reduce lung inflammation.
“Our results show very clearly that for patients hospitalised with COVID-19 azithromycin is not an effective treatment,” Peter Horby, MD, PhD, chief investigator for the trial and a professor of emerging infectious diseases and global health at the University of Oxford, said in a press release. “While that is disappointing, it is nonetheless an important result that will guide clinical care around the world.”
High risk of death, readmission found after hospitalization for COVID-19
A JAMA study yesterday of veterans hospitalized for COVID-19 found that the first 10 days after hospitalization are the most dangerous for patients, with a 40% to 60% higher risk of death or readmission compared with similar patients treated for pneumonia or heart failure.
A research team from the University of Michigan and Veterans Administration (VA) Ann Arbor Healthcare System compared outcomes for 2,179 veterans hospitalized for COVID-19 and discharged from 132 US VA hospitals from Mar 1 to Jul 1 with nearly 5,300 similar patients hospitalized for non–COVID-19 pneumonia and heart failure during the same period.
All but 5% of the patients were male, and half were black, both of which represent groups at high risk of severe COVID-19. Overall, 18.5% of COVID-19 patients died during their hospital stay.
The researchers found a 43% higher risk of readmission or death for patients with COVID-19 in the first 10 days after discharge compared with similar patients with non–COVID-19 pneumonia (hazard ratio [HR], 1.43; 95% confidence interval [CI], 1.09 to 1.87) and a 62% higher risk compared with similar patients with heart failure (HR, 1.62; 95% CI, 1.31 to 2.01). Overall, 9% of discharged VA COVID-19 patients died and 20% required readmission—most often for COVID-19 complications and sepsis, or an extreme reaction to infection—in the 60 days after hospital discharge.
“The study suggests a need for special vigilance in the first days after discharge,” lead author John P. Donnelly, PhD, said in a University of Michigan news release.
“Unfortunately, this is yet more evidence that COVID-19 is not ‘one and done,'” coauthor Theodore J. Iwashyna, MD, PhD, said in the news release. “For many patients, COVID-19 seems to set off cascades of problems that are every bit as serious as those we see in other diseases. But too little of our healthcare response—and too little research—is designed to help these patients as they continue for days, weeks, even months to recover from COVID-19.”
Low risk of severe COVID-19 noted for young kids
A French study in Pediatrics today reports a low risk of severe COVID-19 for children less than 3 months old and points to low blood oxygen levels and high levels of inflammatory proteins as reliable predictors of severe disease in children.
Researchers conducted a surveillance study of 60 hospitals—representing 38.5% of French children hospitalized with SARS-CoV-2. They identified 397 infected children hospitalized from Feb 15 to Jun 1, including 385 children with reverse-transcription polymerase chain reaction (RT-PCR)–confirmed infection and 12 diagnosed via characteristic chest CT-scan lesions. Severe disease was defined as the need for ventilatory or hemodynamic support—efforts to restore blood volume and flow to improve oxygen delivery.
Although infants less than 3 months old were the main group requiring hospitalization in this study (37% of all cases), only 3% had severe disease. Nearly all (92%) of these infants presented with a fever, and the authors noted that hospitalization was a precaution for possible bacterial infection for most of them.
“The use of a rapid test at the bedside to identify SARS-CoV-2 would be helpful to improve the care of these children in pediatric emergency departments,” the authors wrote.
Excluding children with multisystem inflammatory syndrome—a severe COVID-19 complication—and those hospitalized for reasons unrelated to SARS-CoV-2, only 11% of children overall had severe disease (23 of 306), 6 of whom died. While 29% of children in the study had comorbidities, including compromised immune function or chronic respiratory or cardiac diseases, these were not associated with severe disease.
“Our findings suggested that the rate of severe forms was the lowest in very young children and was the highest for children ≥ 10 years,” the authors wrote.
In addition to age greater than 10 years (odds ratio [OR], 3.4; 95% confidence interval [CI], 1.1 to 10.3), other independent risk factors were low blood oxygen at admission (OR, 8.9; 95% CI, 2.6 to 29.7; P = 0.0004) and elevated levels of the inflammatory marker C-reactive protein (OR, 6.6; 95% CI, 1.4 to 27.5; P = 0.012). The authors suggest that monitoring these clinical markers could help identify children at higher risk for increased surveillance and support.
Dec 15 Pediatrics study