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1.
J Health Care Poor Underserved ; 33(1): 517-527, 2022.
Article in English | MEDLINE | ID: covidwho-1686068

ABSTRACT

In 2018, The University of Texas Health Science Center-Tyler and University of Texas Rio Grande Valley were invited to develop clinical research units for an existing Clinical and Translational Science Award (CTSA) consortium with the objective to equip medically underserved, economically disadvantaged communities and subsequently to deploy COVID-19 clinical trials in response to a public health emergency.


Subject(s)
Awards and Prizes , COVID-19 , Clinical Trials as Topic , Humans , Organizations , Rural Population , SARS-CoV-2 , Texas
2.
JAMA Intern Med ; 182(2): 115-126, 2022 02 01.
Article in English | MEDLINE | ID: covidwho-1567885

ABSTRACT

Importance: There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19. Objective: To determine the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen. Design, Setting, and Participants: CONTAIN COVID-19, a randomized, double-blind, placebo-controlled trial of CCP in hospitalized adults with COVID-19, was conducted at 21 US hospitals from April 17, 2020, to March 15, 2021. The trial enrolled 941 participants who were hospitalized for 3 or less days or presented 7 or less days after symptom onset and required noninvasive oxygen supplementation. Interventions: A unit of approximately 250 mL of CCP or equivalent volume of placebo (normal saline). Main Outcomes and Measures: The primary outcome was participant scores on the 11-point World Health Organization (WHO) Ordinal Scale for Clinical Improvement on day 14 after randomization; the secondary outcome was WHO scores determined on day 28. Subgroups were analyzed with respect to age, baseline WHO score, concomitant medications, symptom duration, CCP SARS-CoV-2 titer, baseline SARS-CoV-2 serostatus, and enrollment quarter. Outcomes were analyzed using a bayesian proportional cumulative odds model. Efficacy of CCP was defined as a cumulative adjusted odds ratio (cOR) less than 1 and a clinically meaningful effect as cOR less than 0.8. Results: Of 941 participants randomized (473 to placebo and 468 to CCP), 556 were men (59.1%); median age was 63 years (IQR, 52-73); 373 (39.6%) were Hispanic and 132 (14.0%) were non-Hispanic Black. The cOR for the primary outcome adjusted for site, baseline risk, WHO score, age, sex, and symptom duration was 0.94 (95% credible interval [CrI], 0.75-1.18) with posterior probability (P[cOR<1] = 72%); the cOR for the secondary adjusted outcome was 0.92 (95% CrI, 0.74-1.16; P[cOR<1] = 76%). Exploratory subgroup analyses suggested heterogeneity of treatment effect: at day 28, cORs were 0.72 (95% CrI, 0.46-1.13; P[cOR<1] = 93%) for participants enrolled in April-June 2020 and 0.65 (95% CrI, 0.41 to 1.02; P[cOR<1] = 97%) for those not receiving remdesivir and not receiving corticosteroids at randomization. Median CCP SARS-CoV-2 neutralizing titer used in April to June 2020 was 1:175 (IQR, 76-379). Any adverse events (excluding transfusion reactions) were reported for 39 (8.2%) placebo recipients and 44 (9.4%) CCP recipients (P = .57). Transfusion reactions occurred in 2 (0.4) placebo recipients and 8 (1.7) CCP recipients (P = .06). Conclusions and Relevance: In this trial, CCP did not meet the prespecified primary and secondary outcomes for CCP efficacy. However, high-titer CCP may have benefited participants early in the pandemic when remdesivir and corticosteroids were not in use. Trial Registration: ClinicalTrials.gov Identifier: NCT04364737.


Subject(s)
Blood Component Transfusion , COVID-19/therapy , Critical Illness/therapy , Adult , Aged , Double-Blind Method , Female , Hospitalization/statistics & numerical data , Humans , Immunization, Passive , Male , Middle Aged , Respiration, Artificial/statistics & numerical data , Treatment Outcome , United States
3.
Open forum infectious diseases ; 8(12), 2021.
Article in English | EuropePMC | ID: covidwho-1563852

ABSTRACT

Coronavirus disease 2019 (COVID-19) can become complicated by secondary invasive fungal infections (IFIs), stemming primarily from severe lung damage and immunologic deficits associated with the virus or immunomodulatory therapy. Other risk factors include poorly controlled diabetes, structural lung disease and/or other comorbidities, and fungal colonization. Opportunistic IFI following severe respiratory viral illness has been increasingly recognized, most notably with severe influenza. There have been many reports of fungal infections associated with COVID-19, initially predominated by pulmonary aspergillosis, but with recent emergence of mucormycosis, candidiasis, and endemic mycoses. These infections can be challenging to diagnose and are associated with poor outcomes. The reported incidence of IFI has varied, often related to heterogeneity in patient populations, surveillance protocols, and definitions used for classification of fungal infections. Herein, we review IFI complicating COVID-19 and address knowledge gaps related to epidemiology, diagnosis, and management of COVID-19–associated fungal infections.

4.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-292997

ABSTRACT

Soon after commencement of the SARS-CoV-2 disease outbreak of 2019 (COVID-19), it became evident that the receptor-binding domain of the viral spike protein is the target of neutralizing antibodies that comprise a critical element of protective immunity to the virus. This study addresses the relative lack of information regarding actual antibody concentrations in convalescent plasma samples from COVID-19 patients and extends these analyses to post-vaccination samples to estimate protective IgG antibody (Ab) levels. Both sample populations were similar and a protective Ab level of 7.5 μg/ml was determined, based on 95% of the normal distribution of the post-vaccination population. The results of this study have implications for future vaccine development, projection of protective efficacy duration, and understanding of the immune response to SARS-CoV-2 infection.

5.
Clin Infect Dis ; 73(4): 697-698, 2021 08 16.
Article in English | MEDLINE | ID: covidwho-1483403
6.
Transfusion ; 61(4): 1047-1052, 2021 04.
Article in English | MEDLINE | ID: covidwho-999171

ABSTRACT

BACKGROUND: Convalescent plasma is used as a treatment for COVID-19. Only limited data describe the efforts to recruit COVID-19 convalescent plasma (CCP) donors. We describe our experience engaging persons recovered from COVID-19 to donate CCP. STUDY DESIGN AND METHODS: We performed a retrospective analysis of the CCP recruitment for an 11-hospital health system in Houston, Texas. We sought CCP donations from: a) "volunteers" responding to advertisements in social media, press releases, and websites and b) "referred" individuals directed to the program or identified from hospitalization records. We determined the proportions of donor candidates who passed initial telephone health screening, who qualified after diagnostic testing, who presented to the regional CCP donation center, and who completed CCP donation. RESULTS: There were 900 CCP donor candidates, including 363 volunteers and 537 referred donors. Of 360 contacted volunteers, 186 (5.7%) were excluded by interview; 133 were referred for additional diagnostic screening, 97 completed donor antibody and antigen testing, and 87 were qualified for CCP donation, resulting in 35 CCP donations (9.7% of initial telephone contacts). Among 533 referred donors, 448 (84.1%) were excluded by interview, 71 were referred for additional screening, 48 completed donor antibody and antigen testing, and 40 were qualified for CCP donation, resulting in one CCP donation (0.2% of initial telephone contacts). CONCLUSION: In this community, screening of a high number of candidates yielded a limited number of CCP donations. These observations have important implications for CCP donor recruitment and community pandemic planning.


Subject(s)
Blood Donors , COVID-19/immunology , COVID-19/therapy , Convalescence , Donor Selection , Pandemics , SARS-CoV-2/immunology , Adult , Humans , Immunization, Passive , Male , Middle Aged , Retrospective Studies
7.
Lancet Infect Dis ; 21(6): e149-e162, 2021 06.
Article in English | MEDLINE | ID: covidwho-974782

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 causes direct damage to the airway epithelium, enabling aspergillus invasion. Reports of COVID-19-associated pulmonary aspergillosis have raised concerns about it worsening the disease course of COVID-19 and increasing mortality. Additionally, the first cases of COVID-19-associated pulmonary aspergillosis caused by azole-resistant aspergillus have been reported. This article constitutes a consensus statement on defining and managing COVID-19-associated pulmonary aspergillosis, prepared by experts and endorsed by medical mycology societies. COVID-19-associated pulmonary aspergillosis is proposed to be defined as possible, probable, or proven on the basis of sample validity and thus diagnostic certainty. Recommended first-line therapy is either voriconazole or isavuconazole. If azole resistance is a concern, then liposomal amphotericin B is the drug of choice. Our aim is to provide definitions for clinical research and up-to-date recommendations for clinical management of the diagnosis and treatment of COVID-19-associated pulmonary aspergillosis.


Subject(s)
Antifungal Agents/therapeutic use , COVID-19/complications , Coinfection/drug therapy , Pulmonary Aspergillosis/complications , Pulmonary Aspergillosis/drug therapy , Amphotericin B , Azoles/pharmacology , Humans , Nitriles , Pyridines , SARS-CoV-2 , Triazoles , Voriconazole/therapeutic use
8.
J Otolaryngol Head Neck Surg ; 49(1): 77, 2020 Oct 27.
Article in English | MEDLINE | ID: covidwho-895035

ABSTRACT

BACKGROUND: The COVID-19 pandemic has raised concerns of inadvertent SARS-CoV-2 transmission to healthcare workers during routine procedures of the aerodigestive tract in asymptomatic COVID-19 patients. Current efforts to mitigate this risk focus on Personal Protective Equipment, including high-efficiency filtration as well as other measures. Because the reservoir for SARS-CoV-2 shedding is in the nasopharynx and nasal and oral cavities, the application of viricidal agents to these surfaces may reduce virus burden. Numerous studies have confirmed that povidone-iodine inactivates many common respiratory viruses, including SARS-CoV-1. Povidone-iodine also has good profile for mucosal tolerance. Thus, we propose a prophylactic treatment protocol for the application of topical povidone-iodine to the upper aerodigestive tract. CONCLUSION: Such an approach represents a low-cost, low-morbidity measure that may reduce the risks associated with aerosol-generating procedures performed commonly in otorhinolaryngology operating rooms.


Subject(s)
Betacoronavirus , Coronavirus Infections/epidemiology , Disease Transmission, Infectious/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/epidemiology , Povidone-Iodine/administration & dosage , Adult , Aerosols , Anti-Infective Agents, Local/administration & dosage , COVID-19 , Coronavirus Infections/prevention & control , Humans , Mouth , Pneumonia, Viral/prevention & control , SARS-CoV-2
9.
Am J Infect Control ; 49(4): 508-511, 2021 04.
Article in English | MEDLINE | ID: covidwho-880384

ABSTRACT

The SARS-CoV2 pandemic has created extreme shortages of N95 mask necessitating the need for rapid development of reuse and reprocessing plans. Our aim was to create a process to recapture, reprocess, and redistribute N95 masks using hydrogen peroxide vapor as a real time disinfection method within a large hospital system. We were able to recapture and reprocess 29, 706 N95 masks using hydrogen peroxide vapor with approximately 25% loss due to damage.


Subject(s)
COVID-19/prevention & control , Equipment Reuse , Gases , Hydrogen Peroxide/pharmacology , N95 Respirators/standards , SARS-CoV-2 , Disinfectants/pharmacology , Disinfection/methods , Hospitals , Humans
10.
JCI Insight ; 5(18)2020 09 17.
Article in English | MEDLINE | ID: covidwho-717440

ABSTRACT

Evaluation of potential immunity against the novel severe acute respiratory syndrome (SARS) coronavirus that emerged in 2019 (SARS-CoV-2) is essential for health, as well as social and economic recovery. Generation of antibody response to SARS-CoV-2 (seroconversion) may inform on acquired immunity from prior exposure, and antibodies against the SARS-CoV-2 spike protein receptor binding domain (S-RBD) are speculated to neutralize virus infection. Some serology assays rely solely on SARS-CoV-2 nucleocapsid protein (N-protein) as the antibody detection antigen; however, whether such immune responses correlate with S-RBD response and COVID-19 immunity remains unknown. Here, we generated a quantitative serological ELISA using recombinant S-RBD and N-protein for the detection of circulating antibodies in 138 serial serum samples from 30 reverse transcription PCR-confirmed, SARS-CoV-2-hospitalized patients, as well as 464 healthy and non-COVID-19 serum samples that were collected between June 2017 and June 2020. Quantitative detection of IgG antibodies against the 2 different viral proteins showed a moderate correlation. Antibodies against N-protein were detected at a rate of 3.6% in healthy and non-COVID-19 sera collected during the pandemic in 2020, whereas 1.9% of these sera were positive for S-RBD. Approximately 86% of individuals positive for S-RBD-binding antibodies exhibited neutralizing capacity, but only 74% of N-protein-positive individuals exhibited neutralizing capacity. Collectively, our studies show that detection of N-protein-binding antibodies does not always correlate with presence of S-RBD-neutralizing antibodies and caution against the extensive use of N-protein-based serology testing for determination of potential COVID-19 immunity.


Subject(s)
Antibodies, Neutralizing , Antibodies, Viral , Betacoronavirus/physiology , Coronavirus Infections , Nucleocapsid/immunology , Pandemics , Pneumonia, Viral , Spike Glycoprotein, Coronavirus/immunology , Adaptive Immunity/immunology , Antibodies, Neutralizing/analysis , Antibodies, Neutralizing/immunology , Antibodies, Viral/analysis , Antibodies, Viral/blood , Betacoronavirus/isolation & purification , COVID-19 , COVID-19 Testing , Clinical Laboratory Techniques/methods , Coronavirus Infections/diagnosis , Coronavirus Infections/immunology , Coronavirus Infections/therapy , Coronavirus Infections/virology , Female , Humans , Male , Middle Aged , Outcome Assessment, Health Care , Pneumonia, Viral/immunology , Pneumonia, Viral/therapy , Pneumonia, Viral/virology , Protein Binding , SARS-CoV-2 , Sensitivity and Specificity , Seroconversion , Serologic Tests/methods
11.
Am J Infect Control ; 48(10): 1285, 2020 10.
Article in English | MEDLINE | ID: covidwho-601331

Subject(s)
Hospitals , Humans
12.
J Am Coll Emerg Physicians Open ; 2020 Jun 04.
Article in English | MEDLINE | ID: covidwho-377972

ABSTRACT

There is limited guidance on the use of helicopter medical personnel to facilitate care of critically ill COVID-19 patients. This manuscript describes the emergence of this novel virus, its mode of transmission, and the potential impacts on patient care in the unique environment of rotor wing aircraft. It details the development of clinical and operational guidelines for flight crew members. This allows other out-of-hospital clinicians to utilize our framework to augment or supplement their own for the current response effort to COVID-19. It further serves as a road map for future response to the care of high consequence infectious disease patients.

13.
J Am Coll Emerg Physicians Open ; 1(2): 92-94, 2020 Apr.
Article in English | MEDLINE | ID: covidwho-27131

ABSTRACT

In December 2019, a cluster of severe pneumonia cases of unknown cause was reported in Wuhan, Hubei province, China. A novel strain of coronavirus belonging to the same family of viruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) was identified. In February 2020, cases began being identified in the United States. We describe a sentinel COVID-19 patient in Houston, Texas, who first presented on March 1, 2020. The patient did not meet criteria for a Person Under Investigation (PUI) as recommended by the Centers for Disease Control and Prevention (CDC) at the time. This case has broad implications for emergency department screening and preparedness for COVID-19 and other future infectious diseases.

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