RCT 105 hospitalized patients with mild-to-moderate COVID-19, evaluating the efficacy and safety of local thermotherapy (heating pads applied to the chest for 90 minutes twice daily for 5 days) to prevent disease progression, compared to standard care alone. The thermotherapy was well-tolerated with no significant adverse events.
Reduction in NEWS-2 score was significantly faster with treatment. There was lower progression and mortality with treatment, without statistical significance. The study was underpowered due to early termination.
The temperature used may be too low. Lung temperature is expected to be lower than the external skin surface temperature measured on the thorax, due to heat diffusion and dissipation that occurs in transferring thermal energy across the tissue layers of skin, adipose, muscle, connective tissue and bone between the heating pad and the lung.
The treatment group had greater severity at baseline, NEWS-2 7 vs. 5, and PH-COVID-19 high-risk 7.5% vs. 0%.
Mortality numbers do not match - Figure 3 shows 10 control deaths at 28 days, while Table 3 shows 8. Percentages reported in Table 3 do not match the counts.
ICU numbers do not match the other data, for example in the control group 6 patients required invasive mechanical ventilation and 10 patients died, but only 3 patients were admitted to the ICU.
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risk of death, 43.3% lower, RR 0.57, p = 0.28, treatment 6 of 54 (11.1%), control 10 of 51 (19.6%), NNT 12, day 28.
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risk of death, 43.3% lower, RR 0.57, p = 0.48, treatment 3 of 54 (5.6%), control 5 of 51 (9.8%), NNT 24, day 14.
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risk of mechanical ventilation, 21.3% lower, RR 0.79, p = 0.76, treatment 5 of 54 (9.3%), control 6 of 51 (11.8%), NNT 40.
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risk of progression, 17.4% lower, RR 0.83, p = 0.67, treatment 14 of 54 (25.9%), control 16 of 51 (31.4%), NNT 18.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Mancilla-Galindo et al., 22 Dec 2023, Randomized Controlled Trial, Mexico, peer-reviewed, median age 53.0, 15 authors, study period 27 August, 2020 - 23 August, 2021, heating pad, trial
NCT04363541 (history) (TherMoCoV).
Contact:
ngalindosevilla@hotmail.com.
Regional moderate hyperthermia for mild-to-moderate COVID-19 (TherMoCoV study): a randomized controlled trial
Javier Mancilla-Galindo, Ashuin Kammar-García, María De Lourdes Mendoza-Gertrudis, Javier Michael García Acosta, Yanira Saralee Nava Serrano, Oscar Santiago, Miriam Berenice Torres Vásquez, Daniela Martínez Martínez, Liliana Aline Fernández-Urrutia, Julio César Robledo Pascual, Iván Daniel Narváez Morales, Andrea Aida Velasco-Medina, Javier Mancilla-Ramírez, Ricardo Figueroa-Damián, Norma Galindo-Sevilla
Frontiers in Medicine, doi:10.3389/fmed.2023.1256197
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-tomoderate 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.
Ethics statement The studies involving humans were approved by Dirección General de Calidad y Educación en Salud (CEI-DGCES/2020:03.1) and Instituto Nacional de Perinatología (2020-1- 19) . The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study.
Author contributions
Conflict of interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
Supplementary material The Supplementary material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fmed.2023.1256197/ full#supplementary-material
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