Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04363541

Local Thermotherapy to Prevent Progression in Patients With Mild-to-moderate COVID-19: A Randomized, Open-label Trial

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

274

Participants Needed

3

Research Sites

8 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

Researchers are evaluating the use of local thermotherapy as a treatment to help control mild-to-moderate COVID-19, caused by the SARS-CoV-2 virus. This virus is a positive-sense single-stranded RNA virus responsible for a global pandemic with varying fatality rates. Raising the temperature on affected areas may inhibit viral replication by producing small interfering RNAs that block viral transcription. Thermotherapy has been previously used to target RNA viruses, cancer cells, and parasitic infections, which supports its potential use against COVID-19 to reduce viral load and aid the immune response. The study compares two groups: one receiving usual hospital care plus an electric heat pad applied to the chest for 90 minutes twice daily over 5 days, and the other receiving usual hospital care alone. The heat pad raises the skin temperature to 40-42 0C, a range expected to facilitate virus elimination without causing discomfort. The electric cushion is a commercially available device widely used for muscle pain and arthritis treatment. Participants will undergo evaluations over 28 days to monitor disease progression and other health outcomes such as mortality, time to severe or critical COVID-19, hospitalization duration, oxygen requirement, and adverse events. Clinical status will be assessed using scales like the National Early Warning Score 2 (NEWS-2), and safety and tolerance of the thermotherapy will be tracked. The trial is randomized and open-label, with follow-up visits occurring at multiple time points during and after the treatment period.

CONDITIONS

Brief 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...

  • Adults aged 18 years or older
  • Symptoms of mild or moderate COVID-19, including fever, cough, shortness of breath, or other listed symptoms
  • Mild COVID-19: Peripheral oxygen saturation (SaO2) ≥94% (≥90% in Mexico City and Guadalajara) without severe disease
  • Moderate COVID-19: Pneumonia with risk factors, SaO2 ≥94% (≥90% in Mexico City and Guadalajara) on up to 3 L/min supplemental oxygen, no severe or critical disease
  • Symptoms started 5 days or less before enrollment
  • Ability to understand and accept randomization and procedures
Not Eligible

You will not qualify if you...

  • Suspected or confirmed pregnancy
  • Severe worsening of any underlying diseases
  • Previous COVID-19 diagnosis with full symptom resolution for at least 2 days
  • Severe COVID-19: tachypnea ≥30 breaths/min, SaO2 ≤93% (≤89% in Mexico City and Guadalajara) with up to 3 L/min oxygen, or PaO2/FiO2 ratio <300
  • Critical COVID-19: Acute respiratory distress syndrome, shock, multiorgan failure, or ICU admission required
  • Withdrawal of consent
  • Need for ≥4 L/min supplemental oxygen within first 24 hours of hospitalization
  • Two negative tests for SARS-CoV-2
  • Intolerance to thermotherapy requiring intervention stop
  • Transfer to another medical unit within first 5 days of study inclusion

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 5 days

Participants receive local thermotherapy using an electric heat pad applied on the thorax for 90 minutes, twice daily, for 5 days, in addition to usual in-hospital care.

Daily visits during treatment period

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

J

Javier Mancilla-Galindo, MBBS

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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Published Research Related To This Trial

Identification and characterization of microRNAs from in vitro-grown pear shoots infected with Apple stem grooving virus in response to high temperature using small RNA sequencing.

Juan Liu, XueJiao Zhang, FangPeng Zhang...

https://pubmed.ncbi.nlm.nih.gov/26573813

Regional moderate hyperthermia for mild-to-moderate COVID-19 (TherMoCoV study): a randomized controlled trial.

Javier Mancilla-Galindo, Ashuin Kammar-García, María de Lourdes Mendoza-Gertrudis...

https://pubmed.ncbi.nlm.nih.gov/38188344