Local Thermotherapy for Patients With Mild-to-moderate COVID-19

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Nacional de Perinatologia

About this trial

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.

Eligibility criteria

Qualifiers

Mild COVID-19: With or without mild pneumonia. Peripheral oxygen arterial saturation (SaO2) greater than or equal to 94% (90% in Mexico City and Guadalajara) at room air. Does not meet criteria of moderate, severe, or critical COVID-19.

Moderate COVID-19: Patient with pneumonia and risk factors for disease progression; meeting all the following: Shortness of breath, peripheral oxygen arterial saturation (SaO2) greater than or equal to 94% (90% in Mexico City and Guadalajara) with a maximum 3 L/min of supplementary oxygen, does not meet criteria for severe, or critical COVID-19.

Patient with less than or equal to 5 days from symptom onset

Participant understands the intervention and procedures and accepts randomization.

Disqualifiers

Suspected or confirmed pregnancy at evaluation

Severe decompensation of any of the patient's underlying diseases

Previous diagnosis of COVID-19 with complete resolution of symptoms for at least 2 days.

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.

Trial design

Treatments tested in this trial

  • Electric pad for human external pain therapy

Treatment groups

274 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Instituto Nacional de Perinatologia

Lead sponsor

Direccion General de Calidad y Educacion en Salud

Collaborator

Instituto Mexicano del Seguro Social

Collaborator

Hospital Regional de Alta Especialidad Juan Graham Tabasco

Collaborator

Hospital Dr. Ángel Leaño

Collaborator

National Polytechnic Institute, Mexico

Collaborator

Universidad Juárez Autónoma de Tabasco

Collaborator