Sharing of Individual Patient-Level Data by Trialists of Randomized Clinical Trials of Pharmacological Treatments for COVID-19

Esmail, Laura; Kapp, Philipp; Assi, Rouba; Wood, Julie; Regan, Gabriela; Ravaud, Philippe; Boutron, Isabelle

doi:10.1001/jama.2023.4590

Cited by 11 publications

(5 citation statements)

References 7 publications

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“…During the pandemic, particularly during its early phase, an impressive amount of reports have been published, but often lacking rigorous methodology ( 359 ) and yielding contradictory or unreliable results. Furthermore, global data sharing and accessibility have been rather limited ( 360 ), which still leaves plenty of room for exploration and consolidation of current knowledge. Detailed mechanistic studies and longer term follow-up of PASC will tell us whether and to what extent metabolic alterations are persisting or fully reversible.…”

Section: Conclusion and Future Perspectivesmentioning

confidence: 99%

Diabetes Mellitus, Energy Metabolism, and COVID-19

Conte,

Cipponeri,

Roden

2023

Endocrine Reviews

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Obesity, diabetes mellitus (mostly type 2), and COVID-19 show mutual interactions because they are not only risk factors for both acute and chronic COVID-19 manifestations, but also because COVID-19 alters energy metabolism. Such metabolic alterations can lead to dysglycemia and long-lasting effects. Thus, the COVID-19 pandemic has the potential for a further rise of the diabetes pandemic. This review outlines how preexisting metabolic alterations spanning from excess visceral adipose tissue to hyperglycemia and overt diabetes may exacerbate COVID-19 severity. We also summarize the different effects of SARS-CoV-2 infection on the key organs and tissues orchestrating energy metabolism, including adipose tissue, liver, skeletal muscle, and pancreas. Last, we provide an integrative view of the metabolic derangements that occur during COVID-19. Altogether, this review allows for better understanding of the metabolic derangements occurring when a fire starts from a small flame, and thereby help reducing the impact of the COVID-19 pandemic.

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Section: Conclusion and Future Perspectivesmentioning

confidence: 99%

Diabetes Mellitus, Energy Metabolism, and COVID-19

Conte,

Cipponeri,

Roden

2023

Endocrine Reviews

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“…Our recommendations are complementary to others working in this space, for example, making electronic CRFs more findable, accessible, interoperable, and reusable (FAIR) to support better reuse of clinical research data 20 and auditing if planned data sharing aligns with post-publication reality 21 . A final advantage of defining a standard data model for atomic, individual patient-level data is that the code for transforming curated data into derived variables can be shared across participating sites and reused in multiple trials 22 .…”

Section: Discussionmentioning

confidence: 96%

Automatic Population of the Case Report Forms for an International Multifactorial Adaptive Platform Trial Amid the COVID-19 Pandemic

King,

Higgins,

et al. 2023

Preprint

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Objectives: To automatically populate the case report forms (CRFs) for an international, pragmatic, multifactorial, response-adaptive, Bayesian COVID-19 platform trial. Methods: The locations of focus included 27 hospitals and 2 large electronic health record (EHR) instances (1 Cerner Millennium and 1 Epic) that are part of the same health system in the United States. This paper describes our efforts to use EHR data to automatically populate four of the trial's forms: baseline, daily, discharge, and response-adaptive randomization. Results: Between April 2020 and May 2022, 417 patients from the UPMC health system were enrolled in the trial. A MySQL-based extract, transform, and load pipeline automatically populated 499 of 526 CRF variables. The populated forms were statistically and manually reviewed and then reported to the trial's international data coordinating center. Conclusions: We accomplished automatic population of CRFs in a large platform trial and made recommendations for improving this process for future trials.

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“…The development of drugs, whether approved or not, requires time and funding to determine the therapeutic target, the drug's toxicity, and how to use it properly. 52,53 It has been challenging to draw any consistently valid conclusions about the efficacy of drugs in the treatment of COVID-19 disease 54,55 ; so far the cure has not been achieved with the use of a single particular drug. 52,56 Therefore, it is very important to continue studying potential new therapeutic targets such as: drug repurposing strategies, pan-coronavirus drug targets, in vitro assays, mouse models against SARS-CoV-2 and next Strains.…”

Section: Discussionmentioning

confidence: 99%

Effect of Maraviroc and/or Favipiravir plus systemic steroids versus systemic steroids only on the viral load of adults with severe COVID-19: clinical trial

Medina,

Sanchez-Sandoval,

Barrón-Palma

et al. 2024

F1000Res

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Background Coronavirus disease 2019 (COVID-19) has created the need to evaluate drugs such as favipiravir (FPV), an antiviral inhibitor of RNA-dependent RNA-polymerase (RdRp), and Maraviroc (MVC), an antiretroviral that antagonizes the chemokine receptor CCR5, which could affect the modulation of inflammation and viral replication in the treatment of COVID-19. We sought to evaluate the effect of MVC and/or FPV plus systemic steroid (SS) vs. SS alone on the viral load and progression to critical disease. Methods Sixteen patients with severe COVID-19 were evaluated in three treatment arms: 1) SS only (n=6), 2) SS plus one test drug MVC or FPV (n=5), and 3) SS plus both test drugs (MVC and FPV, n=5). The viral load was determined for N, E, and RdRp viral genes. Results A significant decrease in viral load was observed in the three treatment groups, with a larger effect size in the group that combined SS with both test drugs. The E, N, and RdRp genes with Cohen’s d were 120%, 123%, and 50%, respectively. Conclusions The largest effect on viral load reduction, as measured by effect size, was observed in the combination treatment group; however, no statistical significance was found, and it did not prevent progression to critical illness.

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Sharing of Individual Patient-Level Data by Trialists of Randomized Clinical Trials of Pharmacological Treatments for COVID-19

Abstract: This study describes access to individual patient-level data from randomized clinical trials during the COVID-19 pandemic to determine whether the intent to share what was reported in the registry, publication, or preprint was consistent with actual data access.

Cited by 11 publications

References 7 publications

Diabetes Mellitus, Energy Metabolism, and COVID-19

Diabetes Mellitus, Energy Metabolism, and COVID-19

Automatic Population of the Case Report Forms for an International Multifactorial Adaptive Platform Trial Amid the COVID-19 Pandemic

Effect of Maraviroc and/or Favipiravir plus systemic steroids versus systemic steroids only on the viral load of adults with severe COVID-19: clinical trial

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