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      Regional moderate hyperthermia for mild-to-moderate COVID-19 (TherMoCoV study): a randomized controlled trial

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          Translated abstract

          Background

          To prevent COVID-19 progression, low-cost alternatives that are available to all patients are needed. Diverse forms of thermotherapy have been proposed to prevent progression to severe/critical COVID-19.

          Objective

          The aim of this study is to evaluate the efficacy and safety of local thermotherapy to prevent disease progression in hospitalized adult patients with mild-to-moderate COVID-19.

          Methods

          A multicenter, open-label, parallel-group, randomized, adaptive trial is used to evaluate the efficacy and safety of local thermotherapy to prevent disease progression in hospitalized adult patients with mild-to-moderate COVID-19. Eligible hospitalized adult patients with symptoms of COVID-19 with ≤5 days from symptom onset, meeting criteria for mild or moderate COVID-19, were randomly assigned to the intervention consisting of local thermotherapy via an electric heat pad in the thorax (target temperature range 39.5–42°C) continuously for 90 min, twice daily, for 5 days, or standard care. The main outcome was the proportion of patients who progressed to severe-to-critical COVID-19 or death. Patients were randomized in a 1:1 ratio through a centralized computer-generated sequence of minimization with a random component of 20%. Participants and medical staff were not blinded to the intervention.

          Results

          One-hundred and five participants (thermotherapy n = 54, control n = 51) with a median age of 53 (IQR: 41–64) years were included for analysis after the early cessation of recruitment due to the closure of all temporal COVID-19 units (target sample size = 274). The primary outcome of disease progression occurred in 31.4% (16/51) of patients in the control group vs. 25.9% (14/54) of those receiving thermotherapy (risk difference = 5.5%; 95%CI: −11.8–22.7, p = 0.54). Thermotherapy was well tolerated with a median total duration of thermotherapy of 900 (IQR: 877.5–900) min. Seven (13.7%) patients in the control group and seven (12.9%) in the thermotherapy group had at least one AE ( p = 0.9), none of which were causally attributed to the intervention. No statistically significant differences in serum cytokines (IL-1β, IL-6, IL-8, IL-10, IL-17, and IFN-γ) were observed between day 5 and baseline among groups.

          Conclusion

          Local thermotherapy was safe and well-tolerated. A non-statistically significant lower proportion of patients who experienced disease progression was found in the thermotherapy group compared to standard care. Local thermotherapy could be further studied as a strategy to prevent disease progression in ambulatory settings.

          Clinical Trial registration: www.clinicaltrials.gov, identifier: NCT04363541.

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          Most cited references38

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          Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention

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            A minimal common outcome measure set for COVID-19 clinical research

            Summary Clinical research is necessary for an effective response to an emerging infectious disease outbreak. However, research efforts are often hastily organised and done using various research tools, with the result that pooling data across studies is challenging. In response to the needs of the rapidly evolving COVID-19 outbreak, the Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme, the International Forum for Acute Care Trialists, and the International Severe Acute Respiratory and Emerging Infections Consortium have developed a minimum set of common outcome measures for studies of COVID-19. This set includes three elements: a measure of viral burden (quantitative PCR or cycle threshold), a measure of patient survival (mortality at hospital discharge or at 60 days), and a measure of patient progression through the health-care system by use of the WHO Clinical Progression Scale, which reflects patient trajectory and resource use over the course of clinical illness. We urge investigators to include these key data elements in ongoing and future studies to expedite the pooling of data during this immediate threat, and to hone a tool for future needs.
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              Mild or Moderate Covid-19

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                Author and article information

                Contributors
                URI : https://loop.frontiersin.org/people/1775491/overviewRole: Role: Role: Role: Role: Role: Role:
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                URI : https://loop.frontiersin.org/people/1144956/overviewRole: Role: Role:
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                URI : https://loop.frontiersin.org/people/2265643/overviewRole: Role: Role: Role: Role: Role: Role: Role: Role:
                Journal
                Front Med (Lausanne)
                Front Med (Lausanne)
                Front. Med.
                Frontiers in Medicine
                Frontiers Media S.A.
                2296-858X
                22 December 2023
                2023
                : 10
                : 1256197
                Affiliations
                [1] 1División de Posgrado, Facultad de Medicina, Universidad Nacional Autónoma de México , Mexico City, Mexico
                [2] 2Dirección de Investigación, Instituto Nacional de Geriatría , Mexico City, Mexico
                [3] 3Servicio de Alergia e Inmunología Clínica, Hospital General de México , Mexico City, Mexico
                [4] 4Sección de Estudios de Posgrado e Investigación, Escuela Superior de Medicina, Instituto Politécnico Nacional , Mexico City, Mexico
                [5] 5Unidad Temporal COVID-19 Autónomo Hermanos Rodríguez, Instituto Mexicano del Seguro Social , Mexico City, Mexico
                [6] 6Departamento de Infectología e Inmunología, Instituto Nacional de Perinatología , Mexico City, Mexico
                [7] 7St. Luke Medical School of Alliant International University , Mexico City, Mexico
                [8] 8Hospital Regional de Alta Especialidad “Dr. Juan Graham Casasus”, Secretaría de Salud , Villahermosa, Mexico
                [9] 9Hospital de la Mujer, Secretaría de Salud , Mexico City, Mexico
                Author notes

                Edited by: Deepak Y. Patil, National Institute of Virology (ICMR), India

                Reviewed by: Nasser M. Alorfi, Umm Al Qura University, Saudi Arabia; Seyed Aria Nejadghaderi, Tabriz University of Medical Sciences, Iranl; Ludovica Capitelli, University of Naples Federico II, Italy

                *Correspondence: Norma Galindo-Sevilla, ngalindosevilla@ 123456hotmail.com

                ORCID: Javier Mancilla-Galindo, http://orcid.org/0000-0002-0718-467X

                Ashuin Kammar-García, http://orcid.org/0000-0002-3875-0945

                María de Lourdes Mendoza-Gertrudis, http://orcid.org/0000-0002-3746-092X

                Andrea Aida Velasco-Medina, http://orcid.org/0000-0002-5215-1906

                Javier Mancilla-Ramírez, http://orcid.org/0000-0002-9236-8149

                Norma Galindo-Sevilla, http://orcid.org/0000-0002-6639-8475

                Article
                10.3389/fmed.2023.1256197
                10766786
                26f8ba78-41d2-43ab-834a-6fde99cef08e
                Copyright © 2023 Mancilla-Galindo, Kammar-García, Mendoza-Gertrudis, García Acosta, Nava Serrano, Santiago, Torres Vásquez, Martínez Martínez, Fernández-Urrutia, Robledo Pascual, Narváez Morales, Velasco-Medina, Mancilla-Ramírez, Figueroa-Damián and Galindo-Sevilla.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 10 July 2023
                : 28 November 2023
                Page count
                Figures: 5, Tables: 4, Equations: 0, References: 45, Pages: 14, Words: 9046
                Funding
                The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study was supported by Instituto Nacional de Perinatología ‘Isidro Espinosa de los Reyes’ under Grant INPer 2020-1-19 awarded to NG-S.
                Categories
                Medicine
                Clinical Trial
                Custom metadata
                Pulmonary Medicine

                thermotherapy,non-oncologic applications of hyperthermia,covid-19,sars-cov-2,hypoxemic respiratory failure

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