ABSTRACT
Background: COVID-19 is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Vasoactive Intestinal Peptide (VIP) blocks replication of the SARS-CoV-2 virus in alveolar type II cells, inhibits cytokine synthesis, prevents cytopathy, and up regulates surfactant production. Synthetic VIP-aviptadil is a novel strategy to treat patients with COVID-19 and respiratory failure. Methods: This was a prospective, multicenter, randomized, placebo-controlled trial with 196 patients, nasal swab PCR+ for COVID-19 receiving intensive care at 10 U.S. hospitals (6 tertiary care and 4 regional hospitals) to determine if intravenous aviptadil is superior to placebo in achieving recovery from respiratory failure and survival at 60 days post treatment. The analysis was by modified intent to treat (ITT) using a pre-specified logistic regression model. The primary pre-specified endpoint was being alive with no respiratory failure at day 60. Results: There were 213 subjects screened, with 203 eligible and 196 randomized and treated. Baseline characteristics were comparable except for worse NIAID severity for aviptadil (Table 1). All subjects were followed up to 60 days. A favorable trend (OR 1.63;P=.14) was seen for the primary endpoint at 60 days with significance achieved after adjusting for hospital setting. Overall, there was 2.0-fold increased odds of survival (95% CI 1.05-3.88;P<.035) for aviptadil at Day 60 controlling for baseline NIAID score. Odds of survival increased to over 4-fold after adjusting for site of care (Tertiary care vs regional hospital, OR 4.35 (95% CI 1.91, 9.90;P<.035). Logistic regression indicated aviptadil treated patients were also significantly more likely to be discharged earlier than placebo-treated patients (p=0.01). The most common adverse events noted were diarrhea (32.8% vs. 1.5%) and hypotension (26% vs.21.5%) for aviptadil vs. placebo. Additional adverse events occurring more frequently in aviptadil treated patients included acute kidney injury (23.7% vs 20%), hyperkalemia (12.2% vs 6.2%), and atrial fibrillation (11.5% vs 4.6%). Multiple organ dysfunction syndrome (6.9% vs 13.8%) and respiratory failure (12.2% vs 13.8%) occurred more commonly in placebo-treated patients. Conclusion: Treatment with aviptadil demonstrates efficacy in improving the likelihood of recovering from respiratory failure, surviving to 60 days, and reducing hospital stay in critically ill patients with respiratory failure caused by COVID-19.
ABSTRACT
Background. Migrant farmworkers have been identified as a vulnerable population for Severe Acute Respiratory Syndrome Novel Coronavirus-2 infection (SARS-CoV-2). The objectives of this study were to detect the SARS-CoV-2 infection (COV19) status among 262 migrant farmworkers in North Florida. Methods. This is a retrospective analysis of the information gathered from migrant workers referred by the Florida Dept. of Health for evaluation. Due to the urgency of returning to Mexico, subjects with which COV19 was detected were reevaluated for detailed medical history. Therefore, subjects that tested negative were later released following CDC guidelines. COV19 status was determined using an RNA qualitative nucleic acid amplification test (NAAT) from nasopharyngeal swabs collected over a three-day period. Variables collected include demography, symptoms, temperature, comorbidities, medication use, and vaccine status. Statistical significance for categorical variables was assessed using χ 2 test or Fisher's exact test where appropriate. Remaining variables were assessed using basic descriptive analysis. Results. From the 262 subjects tested, 6 missed the follow up visit and data was unavailable. All were Mexican males, age 18-67 years, with positivity rate of 35.1%. Among the 92 (+) subjects, the average age was 34.1 years and 34.5 among the 164 (-) subjects, (p=< 0.77). The symptoms and temperatures are in Table 1. Three of the 92 COV19 (+) subjects were hospitalized, non-ICU and made an uneventful recovery. 59.8% of COV19 (+) subjects were asymptomatic. Among the 92 (+) subjects, 20.7% reported using acetaminophen within the last 60 days. The most common reported comorbidity was being a former smoker or current smoker, at 12.0% and 4.3% respectively. Conclusion. The COVID-19 pandemic has highlighted migrant workers as a vulnerable population with astronomical COV19 rates, compared to others in FL (14/100,000). They are impoverished, uneducated, undocumented, uninsured and employed to perform arduous physical labor and it is essential to provide basic healthcare to prevent the spread of COV19.