Pentaglobin (immunoglobulin M-enriched immunoglobulin) as adjuvant therapy for premature and very low-birth-weight neonates with sepsis.

OBJECTIVES: The purpose of this research was to determine the effectiveness of Pentaglobin® as adjuvant therapy in the treatment of sepsis in preterm newborns. MATERIALS AND METHODS: It was a prospective, observational, randomized study for 272 premature neonates and very low birth weight (VLBW) that were diagnosed with sepsis carried at neonatal intensive care units. The patients randomized into control group who received standard sepsis antibiotic treatments, and an intervention group who received Pentaglobin® 5 ml/kg daily for 3 consecutive days as an adjunct therapy to a standard sepsis antibiotic treatment. RESULTS: Multiple organisms that isolated from culture specimens were Gram-negative bacteria, Gram-positive, and candida (56.25%, 42.28%, and 1.47%, respectively). The disease duration was distinctively longer in patients who were treated by the standard antibiotic protocol (mean ± standard deviation [SD]: 30.76 ± 3.97, odds ratio [OR]: 30.76, 95% confidence interval [CI]: 30.051, 31.473) comparing to the patients who received Pentaglobin adjuvant therapy (mean ± SD: 26.48 ± 5.55, OR: 26.48, 95% CI: 25.489, 27.477) (P < 0.000). Patients treated by standard antibiotic protocol were associated to a substantially increased risk of death (11.76%, hazard ratio 4.400, 95% CI: 1.432, 13.529, P = 0.009). CONCLUSION: Neonatal sepsis is more common in premature and VLBW newborns, and Pentaglobin® management of newborn nosocomial sepsis might be used in addition to other therapies.

Safety of COVID-19 vaccines.

This study is aimed to identify the adverse effects associated with three types of coronavirus disease 2019 vaccines. Approximately 1736 individuals agreed to participate in this study. The participants involved in the study were individuals who had received the first dose or full course (two doses) of the vaccine at least 30 days before the survey. A direct and interactive web-based system interview with a paper and electronic version of the questionnaire was used for all participants. A total of 1736 randomized individuals were identified. The reactogenicity of the vaccines including pain, redness, urticaria, and swelling at the site of the injection was reported in 34.56% of the participants. Local site reaction was reported in more individuals who had Pfizer and AstraZeneca vaccines than those who received the Sinopharm vaccine. The systemic events were more common with AstraZeneca and Pfizer vaccines, symptoms reported were fatigue, body pain, headache, muscle pain, fever, and gastrointestinal side effects. There were no correlations between age or gender, and the duration of the adverse effects for the three vaccines. Swelling and severe allergic reaction of the eyelids, severe hypotension, generalized body aches, shortness of breath, weakness and numbness on the injected arm, acute hyperglycemia, severe chest pain, and fever more than 39°C were among the unusual signs and symptoms reported by the participants. Pfizer, AstraZeneca, and Sinopharm vaccines were found to be safe and Sinopharm vaccine showed a lower prevalence of adverse effects compared with the other vaccines. The duration and severity of adverse effects were not affected by age or gender. Unusual side effects should be closely monitored to establish determine they are linked to the immunization.

Presenting the characteristics, smoking versus diabetes, and outcome among patients hospitalized with COVID-19.

METHODS: We designed a cross-sectional, observational follow-up for 284 COVID-19 patients involving healthy patients, smokers, diabetics, and diabetic plus smokers recruited from May 1, 2020 to June 25, 2020. The clinical features, severity, duration, and outcome of the disease were analyzed. RESULTS: Of 284 COVID-19 patients, the median age was 48 years (range, 18-80), and 33.80% were female. Common symptoms included fever (85.56%), shortness of breath (49.65%), cough (45.42%), and headache (40.86%). Patients with more than one comorbidity (diabetes and smoking) presented as severe-critical cases compared to healthy patients, diabetics, and smokers. Smokers presented with a lower rate of death in comparison to diabetic patients and diabetic + smoking, furthermore, smoking was less risky than diabetes. Although the mortality rate was high in patients with smokers compared to healthy patients (4.22%, the hazard ratio [HR], 1.358; 95% confidence interval [CI], 1.542-1.100; p = .014), it was less than in diabetics (7.04%, HR 1.531, 95% CI: 1.668-1.337, p = .000), and diabetic plus smoker (10.00%, HR, 1.659; 95% CI, 1.763-1.510; p = .000). CONCLUSION: Multiple comorbidities are closely related to the severity of COVID-19 disease progression and the higher mortality rate. Smokers presented as mild cases compared to diabetic and diabetic + smoking patients, who presented as severe to critical cases. Although a higher death rate in smokers was seen compared with healthy patients, this was smaller when compared to diabetic and diabetic + smoking patients.

Assessment of COVID-19 Treatment containing both Hydroxychloroquine and Azithromycin: A natural clinical trial.

The goal of this study was to assess the clinical effectiveness and safety profile of the COVID-19 treatment protocol (containing both hydroxychloroquine (HCQ) and azithromycin) in an Iraqi specialised hospital. METHODS: This prospective study used a pre- and post-intervention design without a comparison group. The intervention was routine Ministry of Health (MOH) approved the management of COVID-19 for all patients. The study was conducted in a public healthcare setting in Baghdad, Iraq from March 1st to May 25, 2020. The study outcome measures included the changes in clinical and biochemical parameters during the hospitalisation period. Paired t-test and Chi-square test were used to compare the measures of vital signs, lab tests and symptoms before and after treatment. RESULTS: The study included 161 patients who were admitted with positive RT-PCR and clinical symptoms of COVID-19. In terms of severity, 53 (32.9%) patients had amild condition, 47 (29.2%) had moderate condition, 35 (21.7%) had severe condition and 26 (16.1%) had critical condition. Most patients (84.5%) recovered and were discharged without symptoms after testing negative with RT-PCR, while 11 (6.8%) patients died during the study period. The signs and symptoms of COVID-19 were reduced significantly in response to a therapy regimen containing HCQ and azithromycin. The most common reported side effects were stomach pain, hypoglycemia, dizziness, itching, skin rash, QT prolongation, arrhythmia, and conjunctivitis. CONCLUSIONS: This natural trial showed that the COVID-19 regimen containing both HCQ and azithromycin can be helpful to promote the recovery of most patients and reduced their signs and symptoms significantly. It also shows some manageable side effects mostly those related to heart rhythm. In the absence of FDA-approved medications to treat COVID-19, the repurposing of HCQ and azithromycin to control the disease signs and symptoms can be useful.