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researchsquare; 2023.


Objective: Determine whether the tomographic characteristics of patients with COVID-19 pneumonia at the hospital admission and the initial tomographic severity score (TSS) as well as some laboratory tests or clinical characteristics predict mortality. Methods: Retrospective analytical study that included patients with a clinical diagnosis of SARSCoV2 virus infection, performed by reverse transcriptase polymerase chain reaction (RT-PCR), serologic reactive test (IgM/IgG) and/or thoracic computed tomography (CT). Patients were divided into two groups: recovered and deceased. Two radiologists (blind evaluators) described the tomographic findings. TSS, clinical and laboratory parameters in relation to mortality were analyzed. Mortality predictions were made by binary logistic regression. Results: Hypertension was the most frequent associated disease, the most common clinical presentation included cough, discomfort, fever, and dyspnea. The ground glass opacity pattern was the most frequent, followed by consolidation and distortion of the architecture; however, they were not associated with higher mortality. The pattern of pleural effusion and bronchial dilation showed a significant difference from mortality (p <0.05). The binary logistic regression model showed that a moderate and high TSS (≥ 8), as well as a higher degree of lymphopenia, history of asthma and age were associated with an increased risk of death (p< 0.05). Conclusions: TSS is useful in the initial and comprehensive diagnostic evaluation of COVID-19 pneumonia, in conjunction with markers such as lymphopenia that can predict a poor short-term outcome. A high TSS score is a predictor of mortality.

Dyspnea , Asthma , Fever , Pleural Effusion , Pneumonia , Hypertension , Tumor Virus Infections , Lymphopenia , COVID-19
medrxiv; 2022.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2022.09.22.22280247


Background: We investigated whether abatacept, a selective costimulation modulator, provides additional benefit when added to standard-of-care for patients hospitalized with Covid-19. Methods: We conducted a master protocol to investigate immunomodulators for potential benefit treating patients hospitalized with Covid-19 and report results for abatacept. Intravenous abatacept (one-time dose 10 mg/kg, maximum dose 1000 mg) plus standard of care (SOC) was compared with shared placebo plus SOC. Primary outcome was time-to-recovery by day 28. Key secondary endpoints included 28-day mortality. Results: Between October 16, 2020 and December 31, 2021, a total of 1019 participants received study treatment (509 abatacept; 510 shared placebo), constituting the modified intention-to-treat cohort. Participants had a mean age 54.8 (SD 14.6) years, 60.5% were male, 44.2% Hispanic/Latino and 13.7% Black. No statistically significant difference for the primary endpoint of time-to-recovery was found with a recovery-rate-ratio of 1.14 (95% CI 1.00-1.29; p=0.057) compared with placebo. We observed a substantial improvement in 28-day all-cause mortality with abatacept versus placebo (11.0% vs. 15.1%; odds ratio [OR] 0.62 [95% CI 0.41-0.94]), leading to 38% lower odds of dying. Improvement in mortality occurred for participants requiring oxygen/noninvasive ventilation at randomization. Subgroup analysis identified the strongest effect in those with baseline C-reactive protein >75mg/L. We found no statistically significant differences in adverse events, with safety composite index slightly favoring abatacept. Rates of secondary infections were similar (16.1% for abatacept; 14.3% for placebo). Conclusions: Addition of single-dose intravenous abatacept to standard-of-care demonstrated no statistically significant change in time-to-recovery, but improved 28-day mortality. Trial registration: (NCT04593940).

medrxiv; 2022.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2022.09.22.22280245


BackgroundImmune dysregulation contributes to poorer outcomes in severe Covid-19. Immunomodulators targeting various pathways have improved outcomes. We investigated whether infliximab provides benefit over standard of care. MethodsWe conducted a master protocol investigating immunomodulators for potential benefit in treatment of participants hospitalized with Covid-19 pneumonia. We report results for infliximab (single dose infusion) versus shared placebo both with standard of care. Primary outcome was time to recovery by day 29 (28 days after randomization). Key secondary endpoints included 14-day clinical status and 28-day mortality. ResultsA total of 1033 participants received study drug (517 infliximab, 516 placebo). Mean age was 54.8 years, 60.3% were male, 48.6% Hispanic or Latino, and 14% Black. No statistically significant difference in the primary endpoint was seen with infliximab compared with placebo (recovery rate ratio 1.13, 95% CI 0.99-1.29; p=0.063). Median (IQR) time to recovery was 8 days (7, 9) for infliximab and 9 days (8, 10) for placebo. Participants assigned to infliximab were more likely to have an improved clinical status at day 14 (OR 1.32, 95% CI 1.05-1.66). Twenty-eight-day mortality was 10.1% with infliximab versus 14.5% with placebo, with 41% lower odds of dying in those receiving infliximab (OR 0.59, 95% CI 0.39-0.90). No differences in risk of serious adverse events including secondary infections. ConclusionsInfliximab did not demonstrate statistically significant improvement in time to recovery. It was associated with improved 14-day clinical status and substantial reduction in 28- day mortality compared with standard of care. Trial (NCT04593940).

Pneumonia , COVID-19