RESUMO
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) increases mortality rates in older adults and those with comorbidities. Individuals with certain comorbidities may have a poor immune response and require early booster vaccines. We aimed to assess the immune response after two doses of ChAdOx1 nCoV-19 vaccine, at 84-day intervals, in participants with the following comorbidities; diabetes mellitus; obesity; cardiovascular disease; chronic kidney disease; rheumatological disease; cirrhosis; hematological disease; hematological malignancy; or solid malignancy. The study was conducted at Chulabhorn Hospital in Thailand, with healthy healthcare workers serving as the control group. Of the 769 participants, 352 were in the healthy cohort and 417 were in the comorbidity cohort, all received at least one dose of vaccine. Anti-RBD total antibody levels were evaluated on Day 0, Day 84, and Day 112. The results at Day 112 (4 weeks after the second dose) showed that individuals with comorbidities had a poor immune response compared to healthy individuals, especially those with hematological malignancy and solid malignancy. The geometric mean concentration (GMC) of anti-RBD antibody in the comorbidity cohort was significantly lower than that in the healthy cohort: 433.66 BAU/ml (95% CI 334.62-562.01) versus 1096.14 BAU/ml (95% CI 1010.26-1189.33), respectively. The geometric mean ratio (GMR) between the two cohorts was 0.40 (95% CI 0.30-0.52, p < .001). This study concluded that individuals with comorbidities, particularly hematological and solid malignancies, had poor immune responses and may require an early booster vaccine to prevent infection and death.
Assuntos
COVID-19 , Neoplasias Hematológicas , Humanos , Idoso , ChAdOx1 nCoV-19 , Estudos Prospectivos , SARS-CoV-2 , VacinaçãoRESUMO
BACKGROUND: While favipiravir had been the standard anti-SARS-CoV-3 drug for COVID-19 treatment in Thailand, the efficacy of favipiravir treatment is controversial. Andrographis paniculata extract (APE) inhibits viral entry, exhibits immunomodulatory effects, and proposes to have the potential for early-stage COVID-19 treatment. METHODS: A randomized, double-blind, placebo-controlled trial was performed in Thailand during June - September 2021. Non-severe COVID-19 patients were randomized 1:1 to groups receiving 180 mg/day of APE plus favipiravir (APE-FPV group) or placebo plus favipiravir (placebo-FPV group). Efficacy in preventing disease progression to severe COVID-19 was assessed on day 4, using World Health Organization Clinical Progression Scale (WHOCPS) score and visual analog scale (VAS) for acute respiratory tract infection symptoms. RESULTS: Of 146 patients, there were 73 patients in each group. Non-deterioration of WHOCPS scores on day 4 was 98.63% versus 97.26% of patients in the APE-FPV and placebo-FPV groups (p = 1.000). No difference in supplemental oxygen, hospitalization, and death was shown in both groups. The oxygen supplemental was 4.11% in the placebo-FPV group. The interleukin (IL)-1ß was significantly lower in the APE than in the placebo-FPV group throughout the study. We found no difference in virologic outcomes between groups and no substantial adverse events. CONCLUSIONS: APE treatment did not demonstrate additional clinical and virological benefits in patients with mild to moderate COVID-19 being treated with favipiravir. Early reduction of IL-1ß with APE may be advantageous in preventing cytokine storms in severe COVID-19 and requires further study.