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

NCT04363541 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2020-11-05

No results posted yet for this study

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

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04363541 on ClinicalTrials.gov