The etiological agent of the current pandemic is a (+)ssRNA virus. SARS-CoV-2 is infecting thousands of people in the world with a fatality rate that varies from 0.1 to 5% in affected countries, thereby causing enormous economic losses. Few antibiotics have shown any efficacy in their combat, but have not yet proven adequate to stop the spread of the disease, nor are there any approved vaccines at the moment. From experiments in plants ongoing infections by RNA viruses, using thermotherapy, which is the application of heat at a temperature between 35-43 °C, the investigators know that raising the temperature affects the transcription of viral proteins due to the formation of small RNA molecules that interrupt the replication process by grouping in specific regions of the RNA molecule, preventing and inhibiting transcription. These small molecules are called small interfering RNAs (siRNAs). This feature has been used through thermotherapy in humans to combat the rapid replication of cells (i.e. cancer cells), attack cells infected by RNA viruses, and in the treatment of some parasitic infections.There are various commercially available devices for thermotherapy use in humans; they are mainly being used to ease muscle pain. They work by increasing the temperature in the range recommended for thermotherapy in humans 39-43 ° C. Therefore, the investigators consider this treatment modality can be used to aid in the elimination of SARS-CoV-2 from the human body, decreasing viral load, which could allow the immune system time for its control and elimination.
Considering the nature of the causative agent of COVID-19, a (+)ssRNA virus, the investigators propose the use of thermotherapy as a modality for viral containment, thereby preventing the progression of the infection to severe cases. The investigators consider applying the intervention with thermotherapy mainly as an adjuvant therapy in high-risk patients. The most accessible thermotherapy delivery method the investigators have identified is the use of an electric chest pad for its wide and known clinical use, including its recommended use for patients with arthritis. The intensity of temperature delivered by the electric cushion should be placed on the first level (lowest level), to avoid discomfort to the patient. The electric cushion provides a continuous hour of regulated heat, with enough penetration to raise the external temperature of the area to 40-42 ° C, a temperature range at which facilitation of elimination of the virus is expected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
274
An electric pad for local heat production will be put on the back of the patient for two hours
Hospital Dr. Ángel Leaño
Guadalajara, Jalisco, Mexico
RECRUITINGHospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
Villahermosa, Tabasco, Mexico
RECRUITINGUnidad Temporal Movil COVID-19 Autódromo Hermanos Rodríguez IMSS
Mexico City, Mexico
RECRUITINGProgression of disease (composite outcome)
Progression to any of the following: 1. Severe COVID-19 - Patient with ≥1 of the following: tachypnea (≥30 breaths per minute), peripheral oxygen arterial saturation (SaO2) less than or equal to 93% (89% in Mexico City and Guadalajara) with a maximum 3 L/min of supplementary oxygen (patients requiring ≥4 L/min will be considered to have progressed to severe COVID-19), or PaO2/FiO2 ratio \<300. 2. Critical COVID-19 - Patient with ARDS, shock, multiorgan failure, or any other condition requiring admission to an intensive care unit. 3. Death
Time frame: 28 days
Mortality at day 15
Proportion of participants deceased by day 15 after enrollment
Time frame: 15 days
Mortality at day 28
Proportion of participants deceased by day 28 after enrollment
Time frame: 28 days
Time to progression to severe COVID-19
Days from symptom onset to progression to severe COVID-19
Time frame: Up to 33 days
Time to progression to critical COVID-19
Days from symptom onset to progression to critical COVID-19
Time frame: Up to 33 days
Hospitalization time
In-hospital stay in days
Time frame: Up to 33 days
Percentage of participants at each clinical status in the Ordinal Scale at Day 15
Ordinal scale of 7 categories: 1) Not hospitalized, without limitations on daily activities; 2) Not hospitalized, with limitations on daily activities; 3) Hospitalized, not requiring supplementary oxygen; 4) Hospitalized, requiring low-flow supplementary oxygen; 5) Hospitalized, requiring supplementary oxygen with high-flow nasal cannula or non-invasive ventilation; 6) Hospitalized, under invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 7) Death
Time frame: 15 days
Percentage of participants at each clinical status in the Ordinal Scale at Day 28
Ordinal scale of 7 categories: 1) Not hospitalized, without limitations on daily activities; 2) Not hospitalized, with limitations on daily activities; 3) Hospitalized, not requiring supplementary oxygen; 4) Hospitalized, requiring low-flow supplementary oxygen; 5) Hospitalized, requiring supplementary oxygen with high-flow nasal cannula or non-invasive ventilation; 6) Hospitalized, under invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 7) Death
Time frame: 28 days
Time (days) to last requiring supplementary oxygen according to modality
Modalities: 1) Simple nasal cannula or face mask; 2) Face mask with reservoir; 3) High-flow nasal cannula; 4) Non-invasive mechanical ventilation; 5) Invasive mechanical ventilation
Time frame: 28 days
Change in National Early Warning Score 2 (NEWS-2) with respect to baseline
Change in the National Early Warning Score 2 (NEWS-2) with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 \& 28 only for patients that remain hospitalized. This score evaluates 7 parameters (respiratory rate, peripheral arterial oxygen saturation, supplementary oxygen requirements, systolic arterial blood pressure, heart rate, consciousness, and body temperature). Assigned values for every parameter may range from 0 to 3 points, except for supplementary oxygen for which possible values are 0 (not requiring supplementary oxygen) and 2 (requiring supplementary oxygen). The total sum of points for this score may range from 0 to 20 points. Higher scores reflect increasing clinical deterioration.
Time frame: Days 1, 5, 15, and 28
Proportion of patients requiring invasive mechanical ventilation
Proportion of patients requiring invasive mechanical ventilation during the entire follow-up period
Time frame: 28 days
Proportion of patients requiring admission to intensive care unit (ICU)
Proportion of patients requiring admission to intensive care unit (ICU) during the entire follow-up period
Time frame: 28 days
Time to requiring invasive mechanical ventilation
Days from symptom onset to progression to requiring invasive mechanical ventilation
Time frame: Up to 33 days
Time to requiring admission to intensive care unit (ICU)
Days from symptom onset to requiring admission to intensive care unit (ICU)
Time frame: Up to 33 days
Proportion of patients with adverse events according to outcome
* Severe: Causes death of the patient, puts the patient's life at risk in the moment of occurrence, requires hospitalization or prolongs hospitalization, causes persistent or significant disability. * Non-severe adverse events: Do not meet the previously outlined criteria.
Time frame: 28 days
Proportion of patients with adverse events according to severity
* Mild (Grade 1): Present with easily tolerated signs and symptoms, do not need specific treatment, do not prolong hospitalization, nor require suspension of the intervention * Moderate (Grade 2): Interfere with daily activities (school or work), do not directly threaten life, require specific pharmacological treatment, and do not necessarily require suspension of the intervention. * Severe (Grades 3, 4, and 5): Interfere with daily activities (school and work), require pharmacological treatment and suspension of the intervention.
Time frame: 28 days
Proportion of patients with adverse events according to causality
* Certain * Probable * Possible * Uncertain * Unclassifiable
Time frame: 28 days
Proportion of patients tolerating the intervention (no comparison)
Proportion of patients tolerating the intervention (number of sessions and minutes per session).
Time frame: 5 days
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