Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19: An individual participant data meta-analysis.

BACKGROUND: Results from observational studies and randomized clinical trials (RCTs) have led to the consensus that hydroxychloroquine (HCQ) and chloroquine (CQ) are not effective for COVID-19 prevention or treatment. Pooling individual participant data, including unanalyzed data from trials terminated early, enables more detailed investigation of the efficacy and safety of HCQ/CQ among subgroups of hospitalized patients. METHODS: We searched ClinicalTrials.gov in May and June 2020 for US-based RCTs evaluating HCQ/CQ in hospitalized COVID-19 patients in which the outcomes defined in this study were recorded or could be extrapolated. The primary outcome was a 7-point ordinal scale measured between day 28 and 35 post enrollment; comparisons used proportional odds ratios. Harmonized de-identified data were collected via a common template spreadsheet sent to each principal investigator. The data were analyzed by fitting a prespecified Bayesian ordinal regression model and standardizing the resulting predictions. RESULTS: Eight of 19 trials met eligibility criteria and agreed to participate. Patient-level data were available from 770 participants (412 HCQ/CQ vs 358 control). Baseline characteristics were similar between groups. We did not find evidence of a difference in COVID-19 ordinal scores between days 28 and 35 post-enrollment in the pooled patient population (odds ratio, 0.97; 95% credible interval, 0.76-1.24; higher favors HCQ/CQ), and found no convincing evidence of meaningful treatment effect heterogeneity among prespecified subgroups. Adverse event and serious adverse event rates were numerically higher with HCQ/CQ vs control (0.39 vs 0.29 and 0.13 vs 0.09 per patient, respectively). CONCLUSIONS: The findings of this individual participant data meta-analysis reinforce those of individual RCTs that HCQ/CQ is not efficacious for treatment of COVID-19 in hospitalized patients.

Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19: An individual participant data meta-analysis.

Background: Results from observational studies and randomized clinical trials (RCTs) have led to the consensus that hydroxychloroquine (HCQ) and chloroquine (CQ) are not effective for COVID-19 prevention or treatment. Pooling individual participant data, including unanalyzed data from trials terminated early, enables more detailed investigation of the efficacy and safety of HCQ/CQ among subgroups of hospitalized patients. Methods: We searched ClinicalTrials.gov in May and June 2020 for US-based RCTs evaluating HCQ/CQ in hospitalized COVID-19 patients in which the outcomes defined in this study were recorded or could be extrapolated. The primary outcome was a 7-point ordinal scale measured between day 28 and 35 post enrollment; comparisons used proportional odds ratios. Harmonized de-identified data were collected via a common template spreadsheet sent to each principal investigator. The data were analyzed by fitting a prespecified Bayesian ordinal regression model and standardizing the resulting predictions. Results: Eight of 19 trials met eligibility criteria and agreed to participate. Patient-level data were available from 770 participants (412 HCQ/CQ vs 358 control). Baseline characteristics were similar between groups. We did not find evidence of a difference in COVID-19 ordinal scores between days 28 and 35 post-enrollment in the pooled patient population (odds ratio, 0.97; 95% credible interval, 0.76-1.24; higher favors HCQ/CQ), and found no convincing evidence of meaningful treatment effect heterogeneity among prespecified subgroups. Adverse event and serious adverse event rates were numerically higher with HCQ/CQ vs control (0.39 vs 0.29 and 0.13 vs 0.09 per patient, respectively). Conclusions: The findings of this individual participant data meta-analysis reinforce those of individual RCTs that HCQ/CQ is not efficacious for treatment of COVID-19 in hospitalized patients.

A population-based assessment of the health of homeless families in New York City, 2001-2003.

OBJECTIVES: We compared estimated population-based health outcomes for New York City (NYC) homeless families with NYC residents overall and in low-income neighborhoods. METHODS: We matched a NYC family shelter user registry to mortality, tuberculosis, HIV/AIDS, and blood lead test registries maintained by the NYC Department of Health and Mental Hygiene (2001-2003). RESULTS: Overall adult age-adjusted death rates were similar among the 3 populations. HIV/AIDS and substance-use deaths were 3 and 5 times higher for homeless adults than for the general population; only substance-use deaths were higher than for low-income adults. Children who experienced homelessness appeared to be at an elevated risk of mortality (41.3 vs 22.5 per 100,000; P < .05). Seven in 10 adult and child deaths occurred outside shelter. Adult HIV/AIDS diagnosis rates were more than twice citywide rates but comparable with low-income rates, whereas tuberculosis rates were 3 times higher than in both populations. Homeless children had lower blood lead testing rates and a higher proportion of lead levels over 10 micrograms per deciliter than did both comparison populations. CONCLUSIONS: Morbidity and mortality levels were comparable between homeless and low-income adults; homeless children's slightly higher risk on some measures possibly reflects the impact of poverty and poor-quality, unstable housing.

Undiagnosed HIV infection among New York City jail entrants, 2006: results of a blinded serosurvey.

OBJECTIVE: Since 2004, when all New York City jail entrants began being offered rapid testing at medical intake, HIV testing has increased 4-fold. To guide further service improvement, we determined HIV prevalence among jail entrants, including proportion undiagnosed. METHODS: Remnant serum from routine syphilis screening was salvaged for blinded HIV testing in 2006. Using HIV surveillance data and electronic clinical data, we ascertained previously diagnosed HIV infections before permanently removing identifiers. We defined "undiagnosed" as HIV-infected entrants who were unreported to surveillance and denied HIV infection. RESULTS: Among the 6411 jail entrants tested (68.9% of admissions), HIV prevalence was 5.2% overall (males 4.7%; females: 9.8%). Adjusting for those not in the serosurvey, estimated seroprevalence is 8.7% overall (6.5% males, 14% females). Overall, 28.1% of HIV infections identified in the serosurvey were undiagnosed at jail entry; only 11.5% of these were diagnosed during routine jail testing. Few (11.1%) of the undiagnosed inmates reported injection drug use or being men who have sex with men. CONCLUSIONS: About 5%-9% of New York City jail entrants are HIV infected. Of the infected, 28% are undiagnosed; most of whom denied recognized HIV risk factors. To increase inmate's acceptance of routine testing, we are working to eliminate the required separate written consent for HIV testing to allow implementation of the Centers for Disease Control and Prevention-recommended opt out testing model.

Estimates of HIV incidence among persons testing for HIV using the sensitive/less sensitive enzyme immunoassy, New York City, 2001.

BACKGROUND: Estimates of the incidence of HIV infection among persons testing for HIV can be derived by applying a newly available serologic test to the diagnostic specimen of HIV-positive persons. Such estimates would enhance the targeting of HIV prevention resources and provide a sensitive outcome measure for prevention program evaluation. The goal of this investigation was to estimate the incidence of HIV infection among persons testing for HIV in New York City. METHODS: The study population consisted of persons testing for HIV in public settings in New York City during 2001 (n = 114,703). We applied a less sensitive enzyme immunoassay (LS-EIA) (Vironostika, BioMerieux, Durham, NC) to the diagnostic blood specimen of 1022 persons in whom HIV (non-AIDS) had been diagnosed for the first time in 2001. The distribution of transmission risk among HIV-negative persons--men who have sex with men (MSM), injection drug users (IDUs), heterosexuals-from a large telephone health survey was used to generate denominators for transmission risk groups. RESULTS: The 1022 persons tested by the LS-EIA represented 27% of all persons in whom HIV (non-AIDS) had been diagnosed in New York City during 2001. The incidence of HIV was estimated to be 0.29% per year (95% CI: 0.20-0.38), and was significantly higher for men than women (rate ratio 3.6, 95% CI: 2.6-5.1), and HIV incidence increased with age. Male IDU and MSM testers had the highest HIV incidence rates: 2.7% per year (95% CI: 2.3-3.1) and 2.5% per year (95% CI: 2.1-2.8), respectively. CONCLUSIONS: Male IDUs and MSM may be good candidates for intensified targeting of HIV prevention resources in New York City.