Efficacy and safety of convalescent plasma versus standard care in hospitalized patients with COVID-19 from the Peruvian Social Security Health System: open-label, randomized, controlled clinical trial

OBJECTIVESTo assess the efficacy and safety of convalescent plasma plus standard of care (CP + SoC) compared with standard of care (SoC) alone in patients hospitalized for moderate to severe COVID-19 who do not yet require mechanical ventilation. METHODSPhase 2 randomized, parallel-group, randomized, open-label, controlled, superiority, single-center clinical trial. This clinical trial has been registered in REPEC with the following ID: 013-20. Hospitalized adult patients with moderate to severe COVID-19 were enrolled. The allocation ratio was 1:1 in a variable-size permuted block randomization scheme. The primary outcome was death 28 days after the intervention. Secondary outcomes were mortality at 14 and 56 days, time to death at 56 days, time in the ICU at 28 days, time on a mechanical ventilator at 28 days, frequency of adverse events, and frequency of serious adverse events. RESULTSA total of 64 participants were enrolled, 32 were assigned to CP + SoC, and 32 to SoC. One participant assigned to CP + SoC withdrew his informed consent before applying the treatment. At day 28, there were no statistically significant differences for the primary outcome between the CP + SoC and SoC groups (relative risk: 2.06; 95%CI 0.73 to 7.11; p = 0.190). No differences were found in the incidences of mortality at 56 days (hazard ratio: 2.21; 95%CI 0.66 to 7.33; p = 0.182), admission to the ICU at 28 days (sub-hazard ratio: 2.06; 95%CI 0.57 to 8.55; p = 0.250), admission to mechanical ventilation at 28 days (sub-hazard ratio: 2.19; 95%CI 0.57 to 8.51; p = 0.260). Estimates for days 14 were similar. No infusion-related adverse events were reported during the study. There were no statistically significant differences in the frequency of any adverse events (odds ratio: 2.74; 95%CI 0.90 to 9.10; p = 0.085) or the frequency of serious adverse events (odds ratio: 3.60; 95%CI 0.75 to 26.1; p = 0.75). CONCLUSIONSNo evidence was found that CP had a significant effect in reducing 28-day mortality. There was also no evidence that the frequency of adverse events was higher in those who received CP + SoC than those who received only SoC.

Immunogenicity and reactogenicity of a third dose of BNT162b2 vaccine for COVID-19 after a primary regimen with BBIBP-CorV or BNT162b2 vaccines in Lima, Peru.

BackgroundThe administration of a third (booster) dose of COVID-19 vaccines in Peru initially employed the BNT162b2 (Pfizer) mRNA vaccine. The national vaccination program started with healthcare workers (HCW) who received BBIBP-CorV (Sinopharm) vaccine as primary regimen and elderly people previously immunized with BNT162b2. This study evaluated the reactogenicity and immunogenicity of the "booster" dose in these two groups in Lima, Peru. MethodsWe conducted a prospective cohort study, recruiting participants from November to December of 2021 in Lima, Peru. We evaluated immunogenicity and reactogenicity in HCW and elderly patients previously vaccinated with either two doses of BBIBP-CorV (heterologous regimen) or BTN162b2 (homologous regimen). Immunogenicity was measured by anti-SARS-CoV-2 IgG antibody levels immediately before boosting dose and 14 days later. IgG geometric means (GM) and medians were obtained, and modeled using ANCOVA and quantile regressions. ResultsThe GM of IgG levels increased significantly after boosting: from 28.5{+/-}5.0 AU/mL up to 486.6{+/-}1.2 AU/mL (p<0.001) which corresponds to a 17-fold increase. The heterologous vaccine regimen produced higher GM of post-booster anti-SARS-CoV-2 IgG levels, eliciting a 13% fold increase in the geometric mean ratio (95%CI: 1.02-1.27) and a median difference of 92.3 AU/ml (95%CI: 24.9-159.7). Both were safe and well tolerated. Previous COVID-19 infection was also associated with higher pre and post-booster IgG GM levels. ConclusionAlthough both boosting regimens were highly immunogenic, two doses of BBIBP-CorV boosted with BTN162b2 produced a stronger IgG antibody response than the homologous BNT162b2 regimen in the Peruvian population. Additionally, both regimens were mildly reactogenic and well-tolerated.

Narratives of the convalescent plasma donor in a Peruvian social security hospital: motivations, fears, expectations and experiences

ObjectivesTo know and explore from convalescent plasma donators voices the experience in the blood donation process at a Peruvian social security hospital. MethodsQualitative study with a phenomenological design. The investigation was carried out in 01 hospitals of the social security of Peru. Semi-structured interviews were carried out. ResultsEleven donors of convalescent plasma were interviewed. The main motivations for donating were being able to contribute to national research and supporting patients affected by COVID-19. Fears focus on the possible risk of contagion within the hospital. Donors emphasised the attention and support of health personnel alongside the donation procedure. The main expectations and suggestions point towards greater dissemination of donation campaigns with special emphasis on safety. Likewise, an improvement in the time of the donation procedure (from enrolment to the extraction of convalescent plasma), and the implementation of friendly spaces to encourage future blood donation campaigns were highlighted. ConclusionsThe experience of the convalescent plasma donors was positive. However, improvements must be made in terms of processes and infrastructure to ensure future successful blood donation campaigns.

Effects of vaccination against COVID-19 on the emotional health of Peruvian older adults

BackgroundCOVID-19 vaccination may reduce anxiety and depression. However, the pandemic significantly impacted the elderly from low-middle-income countries. Therefore, we aimed to estimate the effect of vaccination against COVID-19 on the emotional health of older adults. MethodsWe selected a nationally stratified sample of non-hospitalized adults aged 60 to 79 years who intended to receive the COVID-19 vaccine or had already received it during recruitment. We assess the fear, anxiety, and worry about COVID-19, general anxiety, and depression at baseline and after a month. We estimated the adjusted odds ratios (aOR) and 95% confidence intervals (95% CI) for each altered emotional health outcomes in those who had one and two doses, compared with those who were not vaccinated using multilevel logistic regression with mixed effects. ResultsWe recruited 861 older adults. Loss to follow-up was 20.8%. At baseline, 43.9% had only one dose of the vaccine, and 49.1% had two doses. In the analysis during follow-up, those who had two doses had less fear (ORa: 0.19; CI95%: 0.07 to 0.51) and anxiety to COVID-19 (ORa: 0.45; CI95%: 0.22 to 0.89), compared to non-vaccinated. We observed no effects in those with only one dose. LimitationsInability to obtain the planned sample size for primary analysis. There is a selection bias during recruitment and a measurement bias because of self-reported vaccination. ConclusionsCOVID-19 vaccination with two doses in elders improves the perception of COVID-19 infection consequences. This information could be integrated into the vaccination campaign as its beneficial effect. HighlightsO_LIUp to 90% of elders in a Peruvian sample had at least one dose of COVID-19 vaccine C_LIO_LITwo doses of COVID-19 vaccine reduced the levels of fear and anxiety for COVID-19 C_LIO_LIOnly one dose of vaccine didnt had effect in any emotional mental outcome C_LI

Real-World Effectiveness of hydroxychloroquine, azithromycin, and ivermectin among hospitalized COVID-19 patients: Results of a target trial emulation using observational data from a nationwide Healthcare System in Peru

IntroductionPeru is one of the most impacted countries due to COVID-19. Given the authorized use of hydroxychloroquine (HCQ), azithromycin (AZIT), and ivermectin (IVM), we aimed to evaluate their effectiveness alone or combined to reduce mortality among COVID-19 hospitalized patients without life-threatening illness. MethodsRetrospective cohort emulating a target trial, using nationwide data of mid- and high-level hospitals from the Peruvian Social Health Insurance 01/April/2020-19/July/2020. Patients 18 yo and above with PCR-confirmed SARS-CoV-2, and no life-threatening illness at admission were included. Five treatment groups (HCQ alone, IVM alone, AZIT alone, HCQ+AZIT, and IVM+AZIT within 48 hours of admission) were compared with standard of care alone. Primary outcome was all-cause mortality rate; secondary outcomes were all-cause death and/or ICU transfer, and all-cause death and/or oxygen prescription. Analyses were adjusted using inverse probability of treatment weighting. Propensity scores were estimated using machine learning boosting models. Weighted hazard ratios (wHR) were calculated using Cox regression. ResultsAmong 5683 patients, 200 received HCT, 203 IVM, 1600 AZIT, 692 HCQ+AZIT, 358 IVM+AZIT, and 2630 standard of care. HCQ+AZIT was associated with 84% higher all-cause death hazard compared to standard care (wHR=1.84, 95%CI 1.12-3.02). Consistently, HCQ+AZIT was also associated with higher death and/or ICU transfer (wHR=1.49, 95%CI 1.01-2.19), and death and/or oxygen prescription (wHR=1.70, 95%CI 1.07-2.69). HCQ only showed higher death and/or oxygen prescription hazard. No effect was found for AZIT or IVM+AZIT. ConclusionsOur study reported no beneficial effects of hydroxychloroquine, ivermectin, azithromycin. The HCQ+AZIT treatment seems to increase risk for all-cause death. FundingInstituto de Evaluacion de Tecnologias en Salud e Investigacion - IETSI, EsSalud

Paradigms about the COVID-2 pandemic: knowledge, attitudes and practices from medical students

BackgroundAs the disease caused by the new coronavirus has spread globally, economic instability in healthcare systems has been significant, and the lack of knowledge, positive attitudes and appropriate practices among people has led to the magnification of this disease. This reality is especially accentuated in Ecuador where, although many healthcare workers have been called to help in the regions most affected, the shortage of them combined with cultural and macroeconomic factors have led Ecuador to face the most aggressive outbreak in Latin America. In this context, the participation on the front line of final year medical students is indispensable. For that reason, appropriate training on COVID-19 for final year medical students is an urgent need that universities and health systems must guarantee. We aimed to describe the knowledge, attitudes and practices in Ecuadorian final year medical students in order to identify the knowledge gaps, perceptions and behavior patterns which could guide the design of better medical education curricula regarding COVID-19. MethodsThis was a cross-sectional 33-item online survey conducted between April 6 to April 20 assessing the knowledge, attitudes, and practices toward the diagnosis, treatment, prevention, and prognosis toward COVID-19 in Ecuadorian final year medical students. It was sent by email and by Facebook and WhatsApp. ResultsA total of 309 students responded to the survey. 88% of students scored high ([≥] 70% correct) for knowledge of the disease. The majority of students were pessimistic about possible government actions, which is reflected in the negative attitude towards the control of COVID-19 in Ecuador and volunteering during the outbreak (77%, and 58% of the students, respectively). Moreover, 91% of students said they did not have adequate protective equipment or training in their health facilities. ConclusionsThe high level of students knowledge, with coexisting negative attitudes, suggests Ecuador has a capable upcoming workforce that could benefit from an opportunity to strengthen, improve and advance their training in preparation for COVID-19. Creating a national curriculum may be one of the most effective ways for all students to be trained, while simultaneously focusing on the students most pressing concerns. Hopefully with this, negative attitudes will improve and students will be better qualified.