The Clinical Course of COVID-19 in the Outpatient Setting: A Prospective Cohort Study

Blair, Paul W; Brown, Diane; Jang, Minyoung; Antar, Annukka A.R.; Keruly, Jeanne C.; Bachu, Vismaya S; Townsend, Jennifer; Tornheim, Jeffrey A.; Keller, Sara C.; Sauer, Lauren; Thomas, David L.; Manabe, Yukari C.; Cox, Andrea L.; Heaney, Chris D; Klein, Sabra L.; Mehta, Shruti H.; Mostafa, Heba H.; Pekosz, Andrew; Pisanic, Nora; Smith, L; Armstrong, Derek T; Azamfirei, Răzvan; Barnaba, Brittany; Charles, Curtisha; Church, Taylor R.; Dai, Weiwei; Fuchs, Joelle; Ganesan, Abhinaya; Hardick, Justin; Holden, Jeffrey; Johnstone, J; Kruczynski, Kate; Kusemiju, Oyinkansola; Lambrou, Anastasia S.; Li, Lucy; Littlefield, Kirsten; Montana, Manuela Plazas; Park, Han-Sol; Payton, Christine; Popper, Caroline; Prizzi, Michelle; Reuland, Carolyn; Sewell, Thelio T; Tuchler, Amanda; Ursin, Rebecca L.; Walch, Samantha N

doi:10.1093/ofid/ofab007

Cited by 56 publications

(71 citation statements)

References 26 publications

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“…B cells were obtained from participants with mild COVID-19 disease, those with moderate to severe disease, and from healthy COVID-19-negative controls (Table 1). Participants with mild COVID-19 disease who never required hospitalization or supplemental oxygen were identified in a previously described cohort of ambulatory patients (27). Symptoms in this cohort were tracked using a FLU-PRO score calculated from a participant survey, as previously described (27).…”

Section: Resultsmentioning

confidence: 99%

“…Participants with mild COVID-19 disease who never required hospitalization or supplemental oxygen were identified in a previously described cohort of ambulatory patients (27). Symptoms in this cohort were tracked using a FLU-PRO score calculated from a participant survey, as previously described (27). To ensure that participants with mild disease were included in this study, a group of 7 participants was selected with a median peak FLU-PRO score below the median peak score for the entire ambulatory cohort (FLU-PRO median of 0.09 [range 0.0-0.38] vs. 0.25 [0.0-1.63]).…”

Section: Resultsmentioning

confidence: 99%

“…The cells were incubated at 37°C for 4 days, visualized by staining with naphthol blue-black, and scored visually for cytopathic effect. A Reed and Muench calculation was used to determine TCID 50 per milliliter (27).…”

Section: Study Participantsmentioning

confidence: 99%

“…For serial dilutions of plasma on S-RBD-coated plates, plasma samples were prepared in 3-fold serial dilutions starting at 1:20 in PBST in 1% nonfat milk. Blocking solution was removed and 10 μL diluted plasma was added in dupli-described (27). Participants with moderate to severe COVID-19 were selected from a cohort of hospitalized patients (28), and matched with the mild participants based on time since onset of symptoms at the time of blood sampling.…”

Section: Measurement Of Endpoint Anti-s-rbd Igg Titermentioning

confidence: 99%

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Durable SARS-CoV-2 B cell immunity after mild or severe disease

Ogega¹,

Skinner²,

Blair³

et al. 2021

Journal of Clinical Investigation

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Study Participantsmentioning

confidence: 99%

Section: Measurement Of Endpoint Anti-s-rbd Igg Titermentioning

confidence: 99%

See 2 more Smart Citations

Durable SARS-CoV-2 B cell immunity after mild or severe disease

Ogega¹,

Skinner²,

Blair³

et al. 2021

Journal of Clinical Investigation

Self Cite

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“…To complement measures of short-term effects such as deaths or number of cases, we also noted the long-term impacts captured by the outpatient journey. Common symptoms often persist over a month (eg, fatigue, cough, headache, sore throat, or loss of smell) [7][8][9], and less frequent ones can be severe since COVID-19 involves many organs. Effects can involve the cardiovascular system in up to 20%-30% of patients who are hospitalized [10,11] (eg, cardiac injury, vascular dysfunction, or thrombosis), result in kidney injury [10] or pulmonary abnormalities [12], or lead to a deterioration in cognition due to cerebral microstructural changes [13].…”

Section: Introductionmentioning

confidence: 99%

Returning to a Normal Life via COVID-19 Vaccines in the United States: A Large-scale Agent-Based Simulation Study

Li¹,

Giabbanelli²

2021

JMIR Med Inform

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Background In 2020, COVID-19 has claimed more than 300,000 deaths in the United States alone. Although nonpharmaceutical interventions were implemented by federal and state governments in the United States, these efforts have failed to contain the virus. Following the Food and Drug Administration's approval of two COVID-19 vaccines, however, the hope for the return to normalcy has been renewed. This hope rests on an unprecedented nationwide vaccine campaign, which faces many logistical challenges and is also contingent on several factors whose values are currently unknown. Objective We study the effectiveness of a nationwide vaccine campaign in response to different vaccine efficacies, the willingness of the population to be vaccinated, and the daily vaccine capacity under two different federal plans. To characterize the possible outcomes most accurately, we also account for the interactions between nonpharmaceutical interventions and vaccines through 6 scenarios that capture a range of possible impacts from nonpharmaceutical interventions. Methods We used large-scale, cloud-based, agent-based simulations by implementing the vaccination campaign using COVASIM, an open-source agent-based model for COVID-19 that has been used in several peer-reviewed studies and accounts for individual heterogeneity and a multiplicity of contact networks. Several modifications to the parameters and simulation logic were made to better align the model with current evidence. We chose 6 nonpharmaceutical intervention scenarios and applied the vaccination intervention following both the plan proposed by Operation Warp Speed (former Trump administration) and the plan of one million vaccines per day, proposed by the Biden administration. We accounted for unknowns in vaccine efficacies and levels of population compliance by varying both parameters. For each experiment, the cumulative infection growth was fitted to a logistic growth model, and the carrying capacities and the growth rates were recorded. Results For both vaccination plans and all nonpharmaceutical intervention scenarios, the presence of the vaccine intervention considerably lowers the total number of infections when life returns to normal, even when the population compliance to vaccines is as low as 20%. We noted an unintended consequence; given the vaccine availability estimates under both federal plans and the focus on vaccinating individuals by age categories, a significant reduction in nonpharmaceutical interventions results in a counterintuitive situation in which higher vaccine compliance then leads to more total infections. Conclusions Although potent, vaccines alone cannot effectively end the pandemic given the current availability estimates and the adopted vaccination strategy. Nonpharmaceutical interventions need to continue and be enforced to ensure high compliance so that the rate of immunity established by vaccination outpaces that induced by infections.

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Reliability and Validity of an Instrument of COVID-19 Patient-Reported Symptoms in Outpatients

Rofail

Griffiths

Flore³

et al. 2022

JAMA Netw Open

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ImportancePatient-reported outcome instruments are key in assessing COVID-19–related symptoms and associated burden. However, a valid and reliable instrument to assess symptom severity and progression among outpatients with COVID-19 is not yet available.ObjectivesTo assess the extent to which the Symptoms Evolution of COVID-19 (SE-C19) instrument is valid, reliable, and able to detect symptom changes in outpatients with COVID-19, as well as to establish a definition of symptom resolution.Design, Setting, and ParticipantsIn this diagnostic/prognostic study, psychometric properties of SE-C19 were assessed in participants recruited into an ongoing, adaptive, phase 1/2/3, randomized, double-blind, placebo-controlled clinical trial, during 2020 to 2022. Adult outpatients with symptomatic COVID-19 were randomized 1:1:1 to receive 2.4 g or 8.0 g intravenous casirivimab and imdevimab or placebo, in outpatient centers at 114 sites, from 2 countries (US and Mexico).Main Outcomes and MeasuresReliability, validity, and sensitivity to change of the SE-C19 were assessed. SE-C19 and Patient Global Impression of Severity (PGIS) were administered daily from predose at day 1 to day 29.ResultsAnalysis was conducted on 657 adult outpatients (342 female patients [52.1%], 562 White patients [85.5%]), and 337 non-Hispanic patients [51.3%]. At baseline, patients reported a mean (SD) of 6.6 (3.9) symptoms (ie, rated as at least mild) with a mean (SD) of 3.8 (3.3) of these symptoms being rated as moderate or severe. Stable patients according to PGIS showed scores with intraclass correlation values indicating moderate-to-good test-retest reliability (ie, 0.50-0.90). At baseline, 20 item scores (87%) varied significantly across PGIS-defined groups, supporting the validity of the SE-C19. A symptom-resolution end point was defined after excluding the item sneezing due to its low ability to discriminate severity levels, and excluding confusion, rash, and vomiting, due to their low prevalence in this population. Symptom resolution required complete absence of all remaining items, except cough, fatigue, and headache, which could be mild or moderate in severity. A total of 19 of 23 items from the SE-C19 instrument were identified as valid and reliable to measure disease-related symptoms in outpatients with COVID-19.Conclusions and RelevanceThis study identified 19 items that are valid and reliable to measure disease-related symptoms in outpatients with COVID-19, and proposed a definition of symptom resolution for potential use in future clinical trials.

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The Clinical Course of COVID-19 in the Outpatient Setting: A Prospective Cohort Study

Cited by 56 publications

References 26 publications

Durable SARS-CoV-2 B cell immunity after mild or severe disease

Durable SARS-CoV-2 B cell immunity after mild or severe disease

Returning to a Normal Life via COVID-19 Vaccines in the United States: A Large-scale Agent-Based Simulation Study

Reliability and Validity of an Instrument of COVID-19 Patient-Reported Symptoms in Outpatients

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