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Studies find no COVID benefit for preventive hydroxychloroquine or for convalescent plasma - CIDRAP
"There are no compelling data to suggest that hydroxychloroquine is effective."
Two studies published yesterday in the New England Journal of Medicine found that two once-promising but largely discredited COVID-19 treatmentshydroxychloroquine and convalescent plasmadidn't prevent infection or lead to clinical improvement. 'No compelling data' The first study, an open-label trial led by researchers at Hospital Germans Trias i Pujol in Barcelona, Spain, involved randomly assigning clusters of healthy adults with high-risk, close-contact exposure to a COVID-19 patient to either 800 milligrams (mg) of hydroxychloroquine followed by 6 days of 400-mg doses or usual care. Of 2,314 contacts of 672 COVID-19 patients identified from Mar 17 to Apr 28, 1,116 were assigned to receive hydroxychloroquine and 1,198 to usual care. Results in the two groups were similar, with 5.7% of participants in the hydroxychloroquine group and 6.2% of the usual-care group becoming ill within 14 days of exposure (risk ratio, 0.86). Patients who received hydroxychloroquine were no less likely to become infected than those receiving usual care (18.7% vs 17.8%). Those in the hydroxychloroquine group had a much higher incidence of adverse events (56.1%) than those who received usual care (5.9%), but there were no reports of severe treatment-related side effects. Those receiving hydroxychloroquine were more likely to test positive for coronavirus antibodies (14.3%) than those in the usual-care group (8.7%). Higher coronavirus loads in both contacts at baseline and in index patients were associated with increased risk of symptomatic COVID-19, but the risk did not differ significantly between the two study groups. Nor did they differ substantially in time to symptomatic infection, with a median of 4 days in the hydroxychloroquine group and 5 days in those receiving usual care. Hydroxychloroquine, an antimalarial drug, has shown antiviral activity in vitro. One randomized, controlled trial of hydroxychloroquine for postexposure prevention showed promise, but the trial design was later called into question. Other studies have found no evidence of prophylaxis efficacy. "Despite the promising in vitro results that placed hydroxychloroquine among the leading candidates for COVID-19 treatment and prophylaxis, there are no compelling data to suggest that hydroxychloroquine is effective," the authors said. No differences in clinical status, outcomes In the second study, a double-blind, randomized trial, a research team led by scientists with Hospital Italiano de Buenos Aires in Argentina compared the outcomes of 228 hospitalized COVID-19 patients with severe pneumonia and low oxygen levels at 12 sites who received 500 milliliters of convalescent plasma with those of 105 patients who received a placebo. No significant difference in clinical status on a six-point ordinal scale was observed between the two groups at 30 days (odds ratio, 0.83). The death rate was 10.96% in the group receiving convalescent plasma and 11.43% in those receiving a placebo (risk difference, -0.46 percentage points). The two groups had similar rates of adverse events (4.8% in the convalescent plasma group vs 1.9% in the placebo group). Concentrations of anti-coronavirus antibodies tended to be greater in the convalescent plasma group than in the control group 2 days after treatment. Convalescent plasma, which is taken from patient donors who have recovered from an infectious disease, has been used for more than a century, with the hope that the infused antibodies will mount an immune response. However, despite being commonly used as a treatment for severe COVID-19, convalescent plasma lacks supporting data from randomized, controlled trials. "In our trial, the use of convalescent plasma therapy in addition to standard treatment in patients with severe pneumonia due to COVID-19 did not reduce mortality or improve other clinical outcomes at day 30 as compared with placebo," the authors wrote. "We believe the use of convalescent plasma as a standard of care in such patients should be reevaluated." They added that future studies of other types of antibody therapies should focus on other patient populations or treatments with other kind of preparations, such as intravenous immunoglobulin or anti-coronavirus monoclonal antibodies.
COVID-19 Scan for Nov 20, 2020 | CIDRAP - CIDRAP
Study details tracheal injuries in long-term ventilated COVID patients A study yesterday found that 47% of COVID-19 patients who required prolonged mechanical ventilation developed potentially life-threatening tracheal (airway) complications. The JAMA Otolaryngology Head & Neck Surgery study found that COVID-19 patients were significantly more likely to suffer full-thickness tracheal lesions (FTTL)tears extending through the tracheal muscle walland tracheoesophageal fistulas (TEF)an abnormal connection between a patient's airway and esophagus, which is the tube leading to the stomach. Serious tracheal complications from prolonged mechanical ventilation are typically rare (0.3% to 3%), but caregivers have observed an unprecedented increase in patients with COVID-19, the study authors note. The retrospective study compared 98 COVID-19 patients hospitalized in Pisa, Italy, for severe respiratory failure from Mar 1 to May 31, 2020, to a control group of 45 non-COVID-19 patients from Mar 1 to May 31, 2019. The mean age of patients in the COVID-19 group was similar to that of the control group (68.8 and 68.5 years, respectively). In the COVID-19 group, 14 patients (47%) had FTTL or TEF as a result of intubation and prolonged ventilation, but only 1 patient (2.2%) in the control group developed FTTL (odds ratio [OR], 38.4; 95% confidence interval [CI]; 4.7 to 316.9). The researchers suggest that a number of mechanisms may explain the incidence of tracheal injury, including early implementation of pronation maneuversplacing patients on their stomach to facilitate ventilationand the resulting increase in ventilation cuff pressure on tracheal walls, blood clotting complications in COVID-19 patients, viral weakening of tracheal tissues, steroid use, and caregiver fatigue contributing to accidents and mistakes. The authors advocate for weekly bronchoscopy to detect tracheal lesions, cautious use of high-dose steroids, and careful monitoring of cuff pressure to prevent tracheal injury in ventilated COVID-19 patients. Nov 19 JAMA Otolaryngol Head Neck Surgstudy MMR vaccine may help prevent COVID-19 A small study today in mBio demonstrates that the measles, mumps, and rubella (MMR) vaccine may protect against COVID-19, as researchers found that levels of mumps immunoglobulin (Ig) G antibodies are inversely correlated with COVID-19 severity in MMR-vaccinated patients. Epidemiologic data point to low COVID-19 death rates in populations with high MMR vaccination rates, but the mechanism of protection is still unclear. This study compared 50 MMR-vaccinated COVID-19 patients with a control group of 30 COVID-19 patients with no record of MMR vaccinations whose antibodies come primarily from previous measles, mumps, and rubella illness. The researchers found a significant inverse correlation (-0.71, P < 0.001) between levels of mumps antibodies and COVID-19 severity in the MMR group. All asymptomatic and functionally immune patients had mumps titersantibody levelsfrom 134 to 300 arbitrary units per milliliter (AU/ml). All 17 patients with mild COVID-19 symptoms had titers below 134 AU/ml, and 11 patients with moderate symptoms had titers below 75 AU/ml. All five hospitalized patients who required oxygen had titers below 32 AU/ml. No significant correlations were found between mumps titers and COVID-19 severity in the control group, or between disease severity and measles or rubella titers in either group. "This adds to other associations demonstrating that the MMR vaccine may be protective against COVID-19, said lead study author Jeffrey E. Gold, president of World Organization, in a news release today from the American Society for Microbiology (ASM), which publishes mBio. Older adultsincluding virtually all people born before 1957likely have MMR antibodies from naturally acquired infections, but these antibodies may have waned by as much as 73% over time, the authors suggest. In addition, the researchers found that the mumps titer was the only MMR titer that steadily decreases over time (9.2% mean annual decay rate), leading to a mean titer of 142 AU/ml 9 years after vaccination. "Based upon our study, it would be prudent to vaccinate those over 40 regardless of whether or not they already have high serum MMR titers," said coauthor David J. Hurley, PhD.Nov 20 mBiostudyNov 20 ASM news release Experts: COVID-19 vaccine distribution needs collaboration, transparency For equitable COVID-19 vaccine distribution, the United States needs diverse clinical trial populations, data transparencyespecially around emergency use authorizationuniversal accessibility, and collaboration, according to a five-point recommendation paper published in Health Affairs yesterday. The vaccine experts add that the federal government must be transparent, timely, and consistent with its communications and guidelines, given that it sets underlying policies and decides on state grants. The authors emphasize partnerships and coordination throughout their recommendations. Groups such as professional medical associations, AARP, and the NAACP can help ensure diverse populations are being included in trials, they say, and the Advisory Committee on Immunization Practices needs continued support from the National Academy of Science, Engineering and Medicine and the National Association of Medicine as it formulates distribution plans. While federal agencies and departments may be working with McKesson, state and local organizations will be needed to get the vaccine to people. The article points to the unique vaccination sites and partners used in the H1N1 pandemic flu vaccine distribution in 2009 and 2010 as an example of how the traditional supply chain was modified to make sure pregnant women, high-risk adults, and children didn't slip through the cracks. An estimated 20% of the US population may be completely uninsured, according to the authors, so they recommend more funding to reach those populations. To help track coverage, the immunization information systems (IIS) should have an opt-out policy and share data across state borders, the experts say. All vaccine administrators ought to help with this, including school nurses, health insurance providers, and Medicaid providers, they add. Currently, the authors say, children and teens have 95% and 80% representation, respectively, in the IIS, but only about 56% adults are documented within the system.Nov 19 Health AffstudyNov 19 Children's Hospital of Philadelphia press release