ABSTRACT
Background and Objective. Convalescent plasma therapy (CPT) may reduce the risk of disease progression among patients with COVID-19. This study was undertaken to evaluate the efficacy and safety of CPT in preventing ICU admission among hospitalized COVID-19 patients. Methods. In this open-label randomized controlled trial, we randomly assigned hospitalized adult patients with COVID-19 in a 1:1 ratio to receive convalescent plasma as an adjunct to standard of care or standard of care alone. The primary endpoint was ICU admission within first 28 days of enrolment. Primary safety endpoints include rapid deterioration of respiratory or clinical status within four hours of convalescent plasma transfusion and cumulative incidence of serious adverse events during the study period including transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), severe allergic reactions, and transfusion-related infections. Results. A total of 22 patients were assigned to receive convalescent plasma as an adjunct to standard of care and 22 to receive standard of care alone. The median time from onset of COVID-19 symptoms to study enrolment was eight days (IQR, 4 to 10). Two patients (9.1%) in the CPT group and one patient (4.5%) in the control group were admitted to the ICU. The primary outcome measure, ICU admission, was not different between the two groups (q-value >0.9). No patient who received convalescent plasma had rapid deterioration of respiratory/clinical status within four hours of transfusion and none developed TRALI, TACO, anaphylaxis, severe allergic reactions, or transfusion-related infections. There was also no significant difference in the secondary outcomes of 28-day mortality (two patients in the CPT group and none in the control group, q-value >0.90), dialysis-free days, vasopressor-free days, and ICU-free days. Conclusions. Among hospitalized COVID-19 patients, no significant differences were observed in the need for ICU admission between patients given CPT as adjunct to standard of care and those who received standard of care alone. Interpretation is limited by early termination of the trial which may have been underpowered to detect a clinically important difference. © 2023 University of the Philippines Manila. All rights reserved.
ABSTRACT
Introduction. In the attempt to control the spread of the disease and the pandemic, numerous COVID-19 vaccines are in development. A review of the evidence on their efficacy and safety are critical. Methods. A search for trials was done using the COVID-19 Living OVerview of Evidence (L·OVE) platform. We also searched for relevant authorization documents and trial reports for COVID-19 vaccines of the US-Food and Drug Authority (US-FDA), the European Medicines Agency (EMA), the United Kingdom Medicines and Health Products Regulatory Agency (MHRA), and the WHO website. We included studies that fulfilled the following inclusion criteria: population – humans;intervention – COVID-19 vaccines;comparison – control or placebo;outcomes – efficacy and adverse events;methods – phase 3 randomized trials. Two reviewers independently screened the reports, assessed the methodological quality, and extracted the data on the trial characteristics and results on vaccine efficacy and safety. The date of last search was March 11, 2021. Results. Interim results of trials investigating five vaccines were identified and included in the review. All five vaccines demonstrated satisfactory vaccine efficacy (VE) against symptomatic COVID-19 infection among adults in the short term with moderate certainty of evidence: BNT162b2, VE 95% (95% CI 90.3, 97.6);mRNA-1273, VE 93.6% (95% CI 88.6, 96.5);ChAdOx1, VE 66.7% (95% CI 57.4, 74.0), Gam-COVID-Vac, VE 91.1% (95% CI 83.6, 95.1);and Ad26.CoV2.S, VE 67.2% (95% CI 59.3, 73.7). Data on the efficacy against severe COVID-19 infection and asymptomatic COVID-19 infection are still inconclusive, except for Ad26.CoV2.S, which demonstrated good efficacy in preventing moderate and/or severe COVID-19 infection and acceptable protection against asymptomatic COVID-19 infection 28 days after vaccination (moderate certainty of evidence). Efficacy data on preventing death from COVID-19 infection are still inconclusive. Very limited phase 3 trial data is available to inform vaccine efficacy against the different variants of SARS-CoV-2. Vaccination with these five vaccines was associated with higher adverse reactions compared to control. These adverse events, due to reactions to the vaccines, were mild to moderate and of short duration. Available evidence on vaccine efficacy and safety is limited, mainly due to the short follow up and the small sample size of specific populations. Conclusion. BNT162b2, mRNA-1273, ChAdOx1, Gam-COVID-Vac and Ad26.CoV.S vaccines demonstrated satisfactory vaccine efficacy against symptomatic COVID-19 infection among adults in the short term with moderate certainty of evidence. Data on the efficacy against severe COVID-19 infection, asymptomatic COVID-19 infection, and death from COVID-19 infection are still inconclusive. Long-term efficacy and safety data, and data on the efficacy against variant strains of SARS-CoV-2 are still lacking. © 2021 University of the Philippines Manila. All rights reserved.
ABSTRACT
Objectives. To describe the clinical profile and factors associated with mortality among the first 200 patients confirmed to have COVID-19 infection admitted in the University of the Philippines – Philippine General Hospital (UP-PGH). Methodology. We conducted a review of adult patients with confirmed COVID-19 infection admitted to the UP-PGH, a designated COVID-19 referral center. Demographic, clinical data and clinical outcomes were extracted from medical records. Frequencies and distributions of various clinical characteristics were described, and factors associated with mortality were investigated. Results. Of the 200 patients in our cohort, most were male (55.5%), and the median age was 56 years old. Underlying comorbid illnesses were present in 67.5% of patients, which included hypertension (49.5%), diabetes mellitus (26.5%), and other cardiovascular diseases (20.5%). The most frequent presenting symptoms were cough (69.0%), fever (58.5%), or shortness of breath (53.0%). Most patients presented with mild (n=41, 20.5%) to moderate illness (n=99, 49.5%) and only 60 were considered severely (n=32, 16.0%) or critically ill (n=28, 14.0%). Many (61%) received empiric antibiotics, while 44.5% received either repurposed drugs or investigational therapies for COVID-19. Bacterial co-infection was documented in 11%, with Klebsiella pneumoniae commonly isolated. In-hospital mortality was 17.5%, which was highest for critical COVID-19 (71.4%). Mortality was observed to be higher among patients aged 60 and above, requiring oxygen, ventilatory support, and ICU admission, and those who developed acute kidney injury, acute stroke, sepsis, and nosocomial pneumonia. Conclusion. Our study confirmed that COVID-19 affects older individuals and those with underlying comorbid conditions. Empiric antimicrobial treatment was given for most patients, despite documentation of bacterial infection in only 11%. K. pneumoniae was commonly isolated, reflecting local epidemiology. The mortality rate during this early period of the pandemic was high and comparable with other institutions. Factors associated with mortality were related to critical COVID-19 and were similar to other studies. © 2021 University of the Philippines Manila. All rights reserved.