Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04363541

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

Led by Instituto Nacional de Perinatologia · Updated on 2020-11-05

274

Participants Needed

3

Research Sites

91 weeks

Total Duration

On this page

Sponsors

I

Instituto Nacional de Perinatologia

Lead Sponsor

D

Direccion General de Calidad y Educacion en Salud

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient has symptoms of COVID-19 such as fever, headache, cough, sore throat, muscle or joint pain, shortness of breath, loss of smell, fatigue, diarrhea, vomiting, or conjunctivitis
  • Patient meets criteria for mild or moderate COVID-19 with specific oxygen saturation levels
  • Patient has had symptoms for 5 days or less
  • Patient understands the intervention, procedures, and accepts randomization
Not Eligible

You will not qualify if you...

  • Patient is pregnant or suspected to be pregnant
  • Severe worsening of any underlying diseases
  • Previous COVID-19 diagnosis with full symptom resolution for at least 2 days
  • Patient meets criteria for severe or critical COVID-19 at evaluation
  • Patient requires more than 3 liters per minute of supplementary oxygen or has severe respiratory distress
  • Patient withdraws consent
  • Patient requires more than 4 liters per minute of supplementary oxygen within 24 hours of hospitalization
  • Two negative SARS-CoV-2 tests
  • Patient cannot tolerate thermotherapy and requests to stop
  • Patient transferred to another medical unit within 5 days of inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Hospital Dr. Ángel Leaño

Guadalajara, Jalisco, Mexico, 45200

Actively Recruiting

2

Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"

Villahermosa, Tabasco, Mexico, 86126

Actively Recruiting

3

Unidad Temporal Movil COVID-19 Autódromo Hermanos Rodríguez IMSS

Mexico City, Mexico, 08400

Actively Recruiting

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Research Team

N

Norma del Carmen Galindo Sevilla, PhD

CONTACT

J

Javier Mancilla-Galindo, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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