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1.
Blood ; 138:2042, 2021.
Article in English | EMBASE | ID: covidwho-1582359

ABSTRACT

Background: The NIH-sponsored observational study “Comparative Study of Haiti and Miami Cohorts of Sickle Cell Disease CSHSCD” (R01HL149121) coordinates the follow up of children with sickle cell disease (SCD) in Haiti and compares it to a Miami cohort of children of either Haitian or African American ethnicity for the purpose of assessing barriers through questionnaires and examining differences in the care received in their respective environments. Methods: Children less than 6 years of age with SCD are eligible for enrollment in five participating sites: University of Miami (UM, Miami, Florida), Hôpital Saint Damien (HSD, Tabarre, Haiti), Hôpital de l' Université d'Etat d'Haïti (HUEH, Port-au-Prince, Haiti), Hôpital Universitaire Justinien (HUJ, Cap Haitien, Haiti), and Hôpital Sacré Coeur (HSC, Milot, Haiti). Medians and interquartile ranges or percentages were compared at baseline regarding demographics, clinical and growth parameters, laboratory tests, and the children's hydroxyurea (HU) utilization during the first year of enrollment (May 25, 2020-May 24,2021). A Likert-scale barrier questionnaire was distributed at baseline to assess differences in healthcare access. A P value <0.05 was considered statistically significant to establish differences. Results: 130 children were enrolled during the reported period. Significant differences were observed in age, weight percentiles, hemoglobin levels, pain rates, HU treatment, and pneumococcal vaccination. Penicillin prophylaxis was always given by oral route in Miami, but only 39.8% times in Haiti, with 58% of children receiving prophylaxis by intramuscular injection every month and 2.2% (N=2 children) with either unknown or not receiving prophylaxis. Previous medication outsourcing accounted for the oral tablet form in Haiti. Parents in Haiti had more barriers regarding not able to afford treatment (21.5% compared to 8.1% in Miami) and had similar responses regarding not able to afford coming to clinic (21.5% vs. 18.9%). Parents in Miami expressed living far away from clinic (70.2% compared to 25.8% in Haiti), but had more help from other family members (78.4% vs. 33.3%). Interestingly, parents in Miami did not know sometimes what to do when the child was sick (40% respondents vs. 11% in Haiti). There were no major differences between the responses from the African Americans and Haitians living in Miami, except for not knowing sometimes what to do when child is sick (African-Americans having less doubts than Haitians;25% vs. 52.6%). In short-term follow up, no enrolled children died, although two eligible children in Haiti died before enrollment. One child developed COVID-19 in Miami with only mild symptoms, which resolved. Conclusion: At entry children in Haiti are older, weigh less, are more anemic, have more pain episodes, and fewer receive hydroxyurea treatment. Under-vaccination with pneumococcal 13-valent conjugate (Prevnar-13) is notable in Haiti. There were significant differences detected on the barrier questionnaire among respondents in both countries. Acknowledgment: We acknowledge NHLBI for supporting this work. [Formula presented] Disclosures: Alvarez: GBT: Membership on an entity's Board of Directors or advisory committees;Forma Therapeutics: Membership on an entity's Board of Directors or advisory committees.

2.
Blood ; 138:4054, 2021.
Article in English | EMBASE | ID: covidwho-1582328

ABSTRACT

[Formula presented] Background: There are significant limitations in Haiti for the diagnosis and management of sickle cell disease (SCD), including the non-availability of universal newborn screening (NBS) and transcranial Doppler (TCD) ultrasound screening, and the lack of diagnostic laboratory resources, oral penicillin and hydroxyurea (HU). Methods: Beginning in September 2019, CSHSCD (R01HL149121), a 5-year NIH-sponsored observational comparative study of children with SCD from Haitian ethnicity in Miami and in Haiti compared to children of African American ethnicity with SCD, was designed to increase access to care in Haiti. The study aims are 1) to compare the incidence of SCD among newborns from Haitian and African American ethnicity in Miami, 2) to establish NBS programs for hemoglobinopathies in Haiti, and 3) to compare cohorts of children in SCD at the study sites. The participating sites are the University of Miami (UM, Miami, Florida), Hôpital Saint Damien (HSD, Tabarre, Haiti), Hôpital de l'Université d'Etat d'Haïti (HUEH, Port-au-Prince, Haiti), Hôpital Universitaire Justinien (HUJ, Cap Haitien, Haiti), and Hôpital Sacré Coeur (HSC, Milot, Haiti). HUJ and HSC use two NBS screening methods (isoelectric focusing and Sickle SCAN rapid test) and HSD and HUEH use isoelectric focusing only. CSHSCD supplies penicillin and HU and trains TCD examiners to implement stroke risk screening. Data are collected in REDCap. Results: During the first 2 years and despite the COVID-19 pandemic, we established NBS sites with a cohesive network of physicians and nurses trained in the care of children with SCD in Haiti. This capacity building will support sustainability of the program. We successfully identified at least 15 new cases of SCD via newborn screening, trained six TCD examiners, and enrolled 130 children with SCD in follow up, providing them with penicillin prophylaxis and hydroxyurea for severe cases according to local protocols. Implementation activities which have helped are close communications between the investigators, monthly Zoom meetings to coordinate efforts with enrollment updates every month, the availability of rapid tests (Sickle SCAN and Gazelle miniature cellulose acetate electrophoresis) for the diagnosis of SCD, especially when there is no laboratory equipment on site. Implementation challenges we have faced are mostly two. The first is the timely completion of DUNS and SAM registration for the two public hospitals, with one site achieving this after 9 months and the other site taking 18 months to complete. The reasons for the delay are the inability for the UM site to direct these efforts, following strict rules, and the Haitian hospital officers' lack of familiarity with website requirements. We were able to achieve these registrations with the assistance of one Haitian study staff who is very acquainted with internet navigation and became familiarized with requirements. Outsourcing materials to Haiti is another major challenge, with either gaps in the delivery of supplies because of multiple steps involved in ordering and shipping or with delays in releasing equipment once it is at the Port-au-Prince customs, resulting in gaps in NBS in one of the sites for 8 weeks. We have minimized these issues by opening a one-year ticket to order materials from the different companies involved. Also, Haiti's lack of infrastructure, available materials and medications, and political instability limit health care delivery. Conclusion: Since its inception, we have achieved major milestones, including capacity building and implementation of NBS, TCD training, and enrollment of children with SCD into the prospective cohorts despite the current COVID-19 pandemic. Material outsourcing challenges have been the major implementation problem we have faced due to systemic factors. We anticipate that these factors will be corrected or minimized as we have learned how to handle them. These problems were expected as part of conducting an international study in a low-resource setting. Acknowledgment: We acknowledg NHLBI for supporting this work. Disclosures: Alvarez: Forma Therapeutics: Membership on an entity's Board of Directors or advisory committees;GBT: Membership on an entity's Board of Directors or advisory committees. Romano: Genentech: Research Funding;Vycor: Current holder of individual stocks in a privately-held company;NovaVision: Consultancy.

3.
Jama-Journal of the American Medical Association ; 326(1):46-55, 2021.
Article in English | Web of Science | ID: covidwho-1330273

ABSTRACT

Importance Preventive interventions are needed to protect residents and staff of skilled nursing and assisted living facilities from COVID-19 during outbreaks in their facilities. Bamlanivimab, a neutralizing monoclonal antibody against SARS-CoV-2, may confer rapid protection from SARS-CoV-2 infection and COVID-19. Objective To determine the effect of bamlanivimab on the incidence of COVID-19 among residents and staff of skilled nursing and assisted living facilities. Design, Setting, and Participants Randomized, double-blind, single-dose, phase 3 trial that enrolled residents and staff of 74 skilled nursing and assisted living facilities in the United States with at least 1 confirmed SARS-CoV-2 index case. A total of 1175 participants enrolled in the study from August 2 to November 20, 2020. Database lock was triggered on January 13, 2021, when all participants reached study day 57. Interventions Participants were randomized to receive a single intravenous infusion of bamlanivimab, 4200 mg (n = 588), or placebo (n = 587). Main Outcomes and Measures The primary outcome was incidence of COVID-19, defined as the detection of SARS-CoV-2 by reverse transcriptase-polymerase chain reaction and mild or worse disease severity within 21 days of detection, within 8 weeks of randomization. Key secondary outcomes included incidence of moderate or worse COVID-19 severity and incidence of SARS-CoV-2 infection. Results The prevention population comprised a total of 966 participants (666 staff and 300 residents) who were negative at baseline for SARS-CoV-2 infection and serology (mean age, 53.0 [range, 18-104] years;722 [74.7%] women). Bamlanivimab significantly reduced the incidence of COVID-19 in the prevention population compared with placebo (8.5% vs 15.2%;odds ratio, 0.43 [95% CI, 0.28-0.68];P < .001;absolute risk difference, -6.6 [95% CI, -10.7 to -2.6] percentage points). Five deaths attributed to COVID-19 were reported by day 57;all occurred in the placebo group. Among 1175 participants who received study product (safety population), the rate of participants with adverse events was 20.1% in the bamlanivimab group and 18.9% in the placebo group. The most common adverse events were urinary tract infection (reported by 12 participants [2%] who received bamlanivimab and 14 [2.4%] who received placebo) and hypertension (reported by 7 participants [1.2%] who received bamlanivimab and 10 [1.7%] who received placebo). Conclusions and Relevance Among residents and staff in skilled nursing and assisted living facilities, treatment during August-November 2020 with bamlanivimab monotherapy reduced the incidence of COVID-19 infection. Further research is needed to assess preventive efficacy with current patterns of viral strains with combination monoclonal antibody therapy. This randomized clinical trial assesses the effect of a single intravenous infusion of bamlanivimab vs placebo on incidence of COVID-19 among residents and staff of skilled nursing and assisted living facilities. Question Among residents and staff of skilled nursing and assisted living facilities with high risk of SARS-CoV-2 exposure, what is the effect of bamlanivimab on the incidence of COVID-19? Findings This randomized phase 3 clinical trial included 966 participants who were residents and staff at US skilled nursing and assisted living facilities with at least 1 confirmed SARS-CoV-2 index case and who were negative at baseline for SARS-CoV-2 infection and serology, enrolled from August to November 2020. The incidence of COVID-19 infection among those treated with bamlanivimab vs placebo was 8.5% vs 15.2%, respectively, a difference that was statistically significant. Meaning Bamlanivimab monotherapy compared with placebo reduced the risk of COVID-19 in residents and staff of skilled nursing and assisted living facilities.

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