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Development and Validation of a Treatment Benefit Index to Identify Hospitalized Patients With COVID-19 Who May
Hyung Park1, Thaddeus Tarpey1, Mengling Liu1,2
1Division of Biostatistics, Department of Population Health, New York University Grossman School of Medicine, New York.
Insights
A new Treatment Benefit Index (TBI) predicts which COVID-19 patients benefit most from convalescent plasma (CCP). This tool helps guide personalized treatment decisions during pandemics.
Area of Science:
- Infectious Diseases
- Clinical Medicine
- Public Health
Background:
- Identifying patients likely to benefit from COVID-19 convalescent plasma (CCP) is crucial for public health.
- Predictive tools are needed to optimize CCP treatment allocation.
Purpose of the Study:
- To develop a Treatment Benefit Index (TBI) predicting relative benefit from CCP versus no CCP in hospitalized COVID-19 patients.
- To utilize baseline characteristics for personalized treatment benefit prediction.
Main Methods:
- A prognostic study using pooled patient data from 8 randomized clinical trials (COMPILE study).
- Developed a TBI using a proportional odds model on 2287 patients, validated on 4 external datasets.
- Utilized World Health Organization (WHO) 11-point ordinal scale as the primary outcome measure.
Main Results:
- The TBI identified patient groups with expected large (B1), moderate (B2), or no/harmful (B3) benefit from CCP.
- Patients with comorbidities, blood type A/AB, and early-stage COVID-19 showed greatest benefit.
- Conversely, those without comorbidities and advanced disease risked harm from CCP.
Conclusions:
- The CCP TBI is a simple, validated tool for quantifying individual patient benefit from CCP.
- This precision medicine approach can guide treatment recommendations and optimize resource allocation during pandemics.
Importance:
Identifying which patients with COVID-19 are likely to benefit from COVID-19 convalescent plasma (CCP) treatment may have a large public health impact.
Objective:
To develop an index for predicting the expected relative treatment benefit from CCP compared with treatment without CCP for patients hospitalized for COVID-19 using patients' baseline characteristics.
Design, Setting, And Participants:
This prognostic study used data from the COMPILE study, ie, a meta-analysis of pooled individual patient data from 8 randomized clinical trials (RCTs) evaluating CCP vs control in adults hospitalized for COVID-19 who were not receiving mechanical ventilation at randomization. A combination of baseline characteristics, termed the treatment benefit index (TBI), was developed based on 2287 patients in COMPILE using a proportional odds model, with baseline characteristics selected via cross-validation. The TBI was externally validated on 4 external data sets: the Expanded Access Program (1896 participants), a study conducted under Emergency Use Authorization (210 participants), and 2 RCTs (with 80 and 309 participants).
Exposure:
Receipt of CCP.
Main Outcomes And Measures:
World Health Organization (WHO) 11-point ordinal COVID-19 clinical status scale and 2 derivatives of it (ie, WHO score of 7-10, indicating mechanical ventilation to death, and WHO score of 10, indicating death) at day 14 and day 28 after randomization. Day 14 WHO 11-point ordinal scale was used as the primary outcome to develop the TBI.
Results:
A total of 2287 patients were included in the derivation cohort, with a mean (SD) age of 60.3 (15.2) years and 815 (35.6%) women. The TBI provided a continuous gradation of benefit, and, for clinical utility, it was operationalized into groups of expected large clinical benefit (B1; 629 participants in the derivation cohort [27.5%]), moderate benefit (B2; 953 [41.7%]), and potential harm or no benefit (B3; 705 [30.8%]). Patients with preexisting conditions (diabetes, cardiovascular and pulmonary diseases), with blood type A or AB, and at an early COVID-19 stage (low baseline WHO scores) were expected to benefit most, while those without preexisting conditions and at more advanced stages of COVID-19 could potentially be harmed. In the derivation cohort, odds ratios for worse outcome, where smaller odds ratios indicate larger benefit from CCP, were 0.69 (95% credible interval [CrI], 0.48-1.06) for B1, 0.82 (95% CrI, 0.61-1.11) for B2, and 1.58 (95% CrI, 1.14-2.17) for B3. Testing on 4 external datasets supported the validation of the derived TBIs.
Conclusions And Relevance:
The findings of this study suggest that the CCP TBI is a simple tool that can quantify the relative benefit from CCP treatment for an individual patient hospitalized with COVID-19 that can be used to guide treatment recommendations. The TBI precision medicine approach could be especially helpful in a pandemic.
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