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1.
N Engl J Med ; 2022 Mar 30.
Article in English | MEDLINE | ID: covidwho-1768967

ABSTRACT

BACKGROUND: Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain. METHODS: In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion. RESULTS: Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized. CONCLUSIONS: In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.).

2.
Transfusion ; 2022 Mar 29.
Article in English | MEDLINE | ID: covidwho-1765061

ABSTRACT

Convalescent plasma, collected from donors who have recovered from a pathogen of interest, has been used to treat infectious diseases, particularly in times of outbreak, when alternative therapies were unavailable. The COVID-19 pandemic revived interest in the use of convalescent plasma. Large observational studies and clinical trials that were executed during the pandemic provided insight into how to use convalescent plasma, whereby high levels of antibodies against the pathogen of interest and administration early within the time course of the disease are critical for optimal therapeutic effect. Several studies have shown outpatient administration of COVID-19 convalescent plasma (CCP) to be both safe and effective, preventing clinical progression in patients when administered within the first week of COVID-19. The United States Food and Drug Administration expanded its emergency use authorization (EUA) to allow for the administration of CCP in an outpatient setting in December 2021, at least for immunocompromised patients or those on immunosuppressive therapy. Outpatient transfusion of CCP and infusion of monoclonal antibody therapies for a highly transmissible infectious disease introduces nuanced challenges related to infection prevention. Drawing on our experiences with the clinical and research use of CCP, we describe the logistical considerations and workflow spanning procurement of qualified products, infrastructure, staffing, transfusion, and associated management of adverse events. The purpose of this description is to facilitate the efforts of others intent on establishing outpatient transfusion programs for CCP and other antibody-based therapies.

3.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-296989

ABSTRACT

BACKGROUND: The efficacy of SARS-CoV-2 convalescent plasma (CCP) for preventing infection in exposed, uninfected individuals is unknown. We hypothesized that CCP might prevent infection when administered before symptoms or laboratory evidence of infection. METHODS: This double-blinded, phase 2 randomized, controlled trial (RCT) compared the efficacy and safety of prophylactic high titer (≥1:320) CCP with standard plasma. Asymptomatic participants aged ≥18 years with close contact exposure to a person with confirmed COVID-19 in the previous 120 hours and negative SARS-CoV-2 test within 24 hours before transfusion were eligible. The primary outcome was development of SARS-CoV-2 infection. RESULTS: 180 participants were enrolled;87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021. Two were excluded for SARS-CoV-2 RT-PCR positivity at screening. Of the remaining 168 participants, 12/81 (14.8%) CCP and 13/87 (14.9%) control recipients developed SARS-CoV-2 infection;6 (7.4%) CCP and 7 (8%) control recipients developed COVID-19 (infection with symptoms). There were no COVID-19-related hospitalizations in CCP and 2 in control recipients. There were 28 adverse events in CCP and 58 in control recipients. Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25.3 vs. 25.2 days;p=0.49) and COVID-19 (26.3 vs. 25.9 days;p=0.35) were similar for both groups. CONCLUSION: In this trial, which enrolled persons with recent exposure to a person with confirmed COVID-19, high titer CCP as post-exposure prophylaxis appeared safe, but did not prevent SARS-CoV-2 infection. Trial Registration: Clinicaltrial.gov number NCT04323800 .

4.
J Acquir Immune Defic Syndr ; 89(1): 1-8, 2022 01 01.
Article in English | MEDLINE | ID: covidwho-1561815

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19) symptoms among people living with HIV (PLWH) are not well described. SETTING: Longitudinal survey within the MACS/WIHS Combined Cohort Study (MWCCS) of PLWH compared with similar HIV-seronegative (SN) individuals. METHODS: Telephone-administered survey of MWCCS participants at 13 clinical research sites across the United States addressing COVID-19 symptoms, SARS-CoV-2 testing, and pandemic impact on social distancing and antiretroviral therapy (ART) use. Primary data collection occurred during May (wave 1), June-July (wave 2), and August-September, 2020 (wave 3). RESULTS: One-third of MWCCS participants were tested for SARS-CoV-2 infection; 10% was tested ≥2 times. Similar proportions of PLWH and SN participants were tested, but SARS-CoV-2 positivity was higher among PLWH than among SN individuals (9.4% vs 4.8%, P = 0.003). Odds of SARS-CoV-2 positivity remained higher among PLWH after adjusting for age, sex, race/ethnicity, and study site (adjusted odds ratio = 2.0, 95% confidence interval = 1.2 to 3.2). SARS-CoV-2 positivity was not associated with CD4 cell counts among PLWH. Among SARS-CoV-2 positive participants, 9% had no symptoms, 7% had 1-2 mild symptoms, and 84% had ≥3 symptoms. Most of the (98%) participants reported physical distancing during all survey waves; self-reported ART adherence among PLWH was not adversely affected during the pandemic compared with the previous year (similar adherence in 89% of participants, improved in 9% of participants, and decreased in 2% of participants). CONCLUSIONS: Despite similar SARS-CoV-2 testing and physical distancing profiles by HIV serostatus among MWCCS participants, PLWH who reported SARS-CoV-2 testing were more likely to have a positive test result. Additional studies are needed to determine whether and why PLWH are at increased risk of SARS-CoV-2 infection.


Subject(s)
COVID-19/diagnosis , Fever/etiology , HIV Infections/complications , Pharyngitis/etiology , SARS-CoV-2/isolation & purification , Aged , CD4 Lymphocyte Count , COVID-19/epidemiology , COVID-19 Testing , Cohort Studies , Cough , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Longitudinal Studies , Male , Middle Aged , Prevalence
5.
Infect Dis Clin Pract (Baltim Md) ; 29(6): e448-e450, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1528217

ABSTRACT

We report on a case of delayed presentation of COVID-19 in a postpartum immunosuppressed patient with the confounding variable of cytomegalovirus viremia. This case highlights the importance of maintaining high suspicion for COVID-19 disease even with delayed onset of symptoms, as this diagnosis as important treatment and public health implications.

6.
HIV Res Clin Pract ; 21(5): 130-139, 2020 10.
Article in English | MEDLINE | ID: covidwho-933809

ABSTRACT

BACKGROUND: SARS-CoV-2 infection among People Living With HIV (PLWH) is not well-described. OBJECTIVE: To study COVID-19 symptoms and SARS-CoV-2 PCR-based swab testing among participants of the Multicenter AIDS Cohort Study (MACS) and Women's Interagency HIV Study (WIHS). METHODS: A telephone survey was collected April-June 30, 2020. Symptom and testing prevalence were explored. Multivariable logistic regression was used to examine the factors associated with SARS-CoV-2 positivity. RESULTS: The survey was completed by 3411 participants, including 2078 (61%) PLWH and 1333 HIV-seronegative (SN) participants from across the US. Thirteen percent (n = 441) were tested for SARS-CoV-2 infection (13.4% of PLWH vs 12.2% of SN). Among those tested, positivity was higher in PLWH than SN (11.2% vs 6.1%, p = 0.08). Reasons for not being tested included testing not being available (30% of participants) and not knowing where to get tested (16% of participants). Most symptoms reported since January 2020 were similar in PLWH and SN, including headache (23% vs. 24%), myalgias (19% vs 18%), shortness of breath (14% vs 13%), chills (12% vs 10%), fever (6% vs 6%) and loss of taste or smell (6% vs 7%). Among PLWH who tested positive for SARS-CoV-2 DNA, the most common symptoms were headache (71%), myalgia (68%), cough (68%) and chills (65%). In multivariable analysis among those tested, the odds of SARS-CoV-2 positivity were higher among PLWH than SN (aOR = 2.22 95%CI = 01.01-4.85, p = 0.046) and among those living with others versus living alone (aOR = 2.95 95%CI = 1.18-7.40). CONCLUSION: Prevalence and type of COVID-19 symptoms were similar in PLWH and SN. SARS-CoV-2 infection may be elevated among PLWH.


Subject(s)
COVID-19/physiopathology , COVID-19/virology , HIV Infections/physiopathology , HIV Infections/virology , Acquired Immunodeficiency Syndrome/epidemiology , Adult , Aged , Aged, 80 and over , Ageusia/epidemiology , Ageusia/virology , Anosmia/epidemiology , Anosmia/virology , COVID-19/epidemiology , Chills/epidemiology , Chills/virology , Coinfection , Cough/epidemiology , Cough/virology , Dyspnea/epidemiology , Dyspnea/virology , Female , Fever/epidemiology , Fever/virology , HIV Infections/epidemiology , Headache/epidemiology , Humans , Middle Aged , Prevalence , SARS-CoV-2/isolation & purification , United States/epidemiology
7.
JMIR Public Health Surveill ; 6(3): e19399, 2020 08 13.
Article in English | MEDLINE | ID: covidwho-713604

ABSTRACT

BACKGROUND: Since the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the number of cases of coronavirus disease (COVID-19) in the United States has exponentially increased. Identifying and monitoring individuals with COVID-19 and individuals who have been exposed to the disease is critical to prevent transmission. Traditional contact tracing mechanisms are not structured on the scale needed to address this pandemic. As businesses reopen, institutions and agencies not traditionally engaged in disease prevention are being tasked with ensuring public safety. Systems to support organizations facing these new challenges are critically needed. Most currently available symptom trackers use a direct-to-consumer approach and use personal identifiers, which raises privacy concerns. OBJECTIVE: Our aim was to develop a monitoring and reporting system for COVID-19 to support institutions conducting monitoring activities without compromising privacy. METHODS: Our multidisciplinary team designed a symptom tracking system after consultation with experts. The system was designed in the Georgetown University AvesTerra knowledge management environment, which supports data integration and synthesis to identify actionable events and maintain privacy. We conducted a beta test for functionality among consenting Georgetown University medical students. RESULTS: The symptom tracker system was designed based on guiding principles developed during peer consultations. Institutions are provided access to the system through an efficient onboarding process that uses clickwrap technology to document agreement to limited terms of use to rapidly enable free access. Institutions provide their constituents with a unique identifier to enter data through a web-based user interface to collect vetted symptoms as well as clinical and epidemiologic data. The website also provides individuals with educational information through links to the COVID-19 prevention recommendations from the US Centers for Disease Control and Prevention. Safety features include instructions for people with new or worsening symptoms to seek care. No personal identifiers are collected in the system. The reporter mechanism safeguards data access so that institutions can only access their own data, and it provides institutions with on-demand access to the data entered by their constituents, organized in summary reports that highlight actionable data. Development of the system began on March 15, 2020, and it was launched on March 20, 2020. In the beta test, 48 Georgetown University School of Medicine students or their social contacts entered data into the system from March 31 to April 5, 2020. One of the 48 users (2%) reported active COVID-19 infection and had no symptoms by the end of the monitoring period. No other participants reported symptoms. Only data with the unique entity identifier for our beta test were generated in our summary reports. CONCLUSIONS: This system harnesses insights into privacy and data sharing to avoid regulatory and legal hurdles to rapid adaption by entities tasked with maintaining public safety. Our pilot study demonstrated feasibility and ease of use. Refinements based on feedback from early adapters included release of a Spanish language version. These systems provide technological advances to complement the traditional contact tracing and digital tracing applications being implemented to limit SARS-CoV-2 transmission during reopening.


Subject(s)
Commerce/organization & administration , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Public Health Surveillance/methods , Safety , COVID-19 , Contact Tracing/economics , Coronavirus Infections/epidemiology , Feasibility Studies , Humans , Pilot Projects , Pneumonia, Viral/epidemiology , Privacy , Symptom Assessment , United States/epidemiology
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