ABSTRACT
Background: Vaccine hesitancy, driven by individual, social, and regional factors, can reduce SARS-CoV-2 vaccine uptake among the public. Vaccination is critical for people with HIV (PWH) who are at greater risk of COVID-19-related complications due to HIV-related comorbidities and disparities. This study evaluates the attitudes, concerns, and levels of confidence that underlie COVID-19 vaccination among PWH in Argentina and the Southeastern US.Methods: Participants (n = 2,100) were PWH living in Argentina (n = 1,924 PWH) and Miami, FL (n = 176 PWH). Participants were surveyed regarding COVID-19 vaccine hesitancy.Results: Ages ranged from 18 to 96, with an average of 43·97 (SD = 11.44). Comparing attitudes toward COVID-19 vaccination in these two locations, a greater proportion of Argentine participants agreed that vaccination is important for health, disease prevention, protecting the community, and protection against diseases (p < ·05). Argentine participants were more likely to trust their government and health care providers about vaccines than those in Miami, Florida (p < ·001). More American participants perceived COVID vaccine to be risky and worried about side effects (p < ·001). More Argentine participants believed that a vaccine would prevent COVID-19 and were more willing to vaccinate than American participants (p < ·001). Overall, most vaccine hesitancy items predicted willingness to vaccinate in both countries.Conclusion: Targeted strategies to increase vaccine uptake among PWH should include reducing disinformation, increasing trust, and enhancing the patient-provider relationship. The distribution of vaccine information should use a multi-stakeholder approach that addresses diverse concerns affecting PWH.Funding Statement: This work was supported by National Institutes of Health grants to the University of Miami Center for AIDS Research grant (P30A1073961) and the Center for HIV and Research in Mental Health (P30MH116867). VJR’s work on this manuscript was partially supported by a Ford Foundation Fellowship, administered by the National Academies of Sciences, Engineering, and Medicine.Declaration of Interests: All authors declare no conflicts of interest other than research funding related to the work presented in this manuscript.Ethics Approval Statement: Ethical approvals were obtained from institutional review boards of Fundación Huésped, Centro Médico Huésped, Helios Salud, and University of Miami Miller School of Medicine. Online informed consent was obtained from all Argentine candidates when they agreed to participate in the survey in Argentina. In Miami, FL, telephonic informed consent was obtained prior to beginning the survey.
Subject(s)
COVID-19 , HIV Infections , Acquired Immunodeficiency SyndromeABSTRACT
Background: Passive immunotherapy is a therapeutic alternative for patients with COVID-19. Equine polyclonal antibodies (EpAbs) could represent a source of easily scaled up neutralizing antibodies against SARS-CoV-2.Methods: We conducted a double-blind, randomized, placebo-controlled trial of EpAbs (INM005) in hospitalized adult patients with moderate and severe COVID-19 pneumonia in 19 hospitals of Argentina. Primary endpoint was improvement in at least two categories in WHO ordinal clinical scale at day 28 (ClinicalTrials.gov number NCT04494984).Findings: Enrolled patients were assigned to receive two doses of INM005 (n=118) or placebo (n=123). Median age was 54 years old, 65·1% were male and 61% had moderate disease at baseline. The median time from the onset of COVID-19 symptoms to the administration of the first dose of intervention was 6 days (interquartile range 5 to 8 days). At day 28 no significant difference was noted between study groups on primary endpoint (odds ratio, 1·61%, 95% confidence interval [95%CI] 0·71 to 3·63 p=0·34); however, overall variation in ordinal clinical status during the 28 days follow up period favored INM005. Improvement in at least two categories was significantly higher in INM005 at days 7, 14 and 21 of follow up. A significant difference was noted in time to improvement in at least two ordinal categories or hospital discharge: 14·2 (± 0·7) days in the INM005 group and 16·3 (± 0·7) days in the placebo group. Pre-specified subgroup analyses showed a more pronounced effect of the intervention over severe patients and with no antibody response at baseline. Overall mortality was 6·8% the INM005 group and 11·4% in the placebo group.Interpretation: Albeit not having reached the primary endpoint, we found clinical improvement of hospitalized patients with SARS-CoV-2 pneumonia, particularly those with severe disease. Funding: Funded by Inmunova and grants from the Ministries of Science and Production of Argentina.Trial Registration: ClinicalTrials.gov number NCT04494984Declaration of Interests: MC, SS, VZ, LM, LS, FG received grants from Ministerio de Desarrollo Productivo “Programa soluciona. reactivación de la economía del conocimiento” and Agencia Nacional de Promoción de la Investigación, el Desarrollo Tecnológico y la Innovación del Ministerio de Ciencia, Tecnología e Innovación. MD, JF, GV, AB, FC, MFA, LB, RT, SL, DS, MI, VS, RS, PC, MMC, LA, HLL, AC, DC declare reimbursement for conduction of clinical trial as investigator of the study. PC, OS, YK report other funds from Inmunova. EN, GL, WHB, SPLL report personal fees from Inmunova. AP, B de M, SM, Gabriel L declare no competing interests. SPLL declare personal fees from Movement Disorders Society, Laboratorio Elea and Merck pharmaceuticals.Ethics Approval Statement: The study protocol was approved by the Institutional Review Boards of all participant clinical sites as well as regional or jurisdictional Ethics Committees as applicable. The Argentinean National Administration of Medicines, Food and Medical Technology (ANMAT) also approved the study protocol.
Subject(s)
Pneumonia , Leigh Disease , Retinoschisis , Movement Disorders , COVID-19ABSTRACT
BackgroundA false-negative case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2) infection is defined as a person with suspected infection and an initial negative result by reverse transcription-polymerase chain reaction (RT-PCR) test, with a positive result on a subsequent test. False-negative cases have important implications for isolation and risk of transmission of infected people and for the management of coronavirus disease 2019 (COVID-19). We aimed to review and critically appraise evidence about the rate of RT-PCR false-negatives at initial testing for COVID-19. MethodsWe searched MEDLINE, EMBASE, LILACS, as well as COVID-19 repositories including the EPPI-Centre living systematic map of evidence about COVID-19 and the Coronavirus Open Access Project living evidence database. Two authors independently screened and selected studies according to the eligibility criteria and collected data from the included studies. The risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. We calculated the proportion of false-negative test results with the corresponding 95% CI using a multilevel mixed-effect logistic regression model. The certainty of the evidence about false- negative cases was rated using the GRADE approach for tests and strategies. All information in this article is current up to July 17, 2020. ResultsWe included 34 studies enrolling 12,057 COVID-19 confirmed cases. All studies were affected by several risks of bias and applicability concerns. The pooled estimate of false-negative proportion was highly affected by unexplained heterogeneity (tau-squared= 1.39; 90% prediction interval from 0.02 to 0.54). The certainty of the evidence was judged as very low, due to the risk of bias, indirectness, and inconsistency issues. ConclusionsThere is a substantial and largely unexplained heterogeneity in the proportion of false-negative RT-PCR results. The collected evidence has several limitations, including risk of bias issues, high heterogeneity, and concerns about its applicability. Nonetheless, our findings reinforce the need for repeated testing in patients with suspicion of SARS-CoV-2 infection given that up to 54% of COVID-19 patients may have an initial false-negative RT-PCR (certainty of evidence: very low). An update of this review when additional studies become available is warranted. Systematic review registrationProtocol available on the OSF website: https://osf.io/gp38w/