Local Thermotherapy for Patients With Mild-to-moderate COVID-19
NCT04363541 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274
Last updated 2020-11-05
Summary
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.
Conditions
- COVID-19
- Thermotherapy
Interventions
- DEVICE
-
Electric pad for human external pain therapy
An electric pad for local heat production will be put on the back of the patient for two hours
Sponsors & Collaborators
-
Direccion General de Calidad y Educacion en Salud
collaborator UNKNOWN -
Instituto Mexicano del Seguro Social
collaborator OTHER_GOV -
Hospital Regional de Alta Especialidad Juan Graham Tabasco
collaborator UNKNOWN -
Hospital Dr. Ángel Leaño
collaborator UNKNOWN -
National Polytechnic Institute, Mexico
collaborator OTHER -
Universidad Juárez Autónoma de Tabasco
collaborator OTHER -
Instituto Nacional de Perinatologia
lead OTHER_GOV
Principal Investigators
-
Norma del Carmen Galindo Sevilla, PhD · Instituto Nacional de Perinatología
-
Javier Mancilla-Galindo, MBBS · Instituto Nacional de Cardiología
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-27
- Primary Completion
- 2022-04-30
- Completion
- 2022-06-30
- FDA Device
- Yes
Countries
- Mexico
Study Locations
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