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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-27

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Considering the nature of the causative agent of COVID-19, a (+)ssRNA virus, the investigators propose the use of thermotherapy as a modality for viral containment, thereby preventing the progression of the infection to severe cases. The investigators consider applying the intervention with thermotherapy mainly as an adjuvant therapy in high-risk patients. The most accessible thermotherapy delivery method the investigators have identified is the use of an electric chest pad for its wide and known clinical use, including its recommended use for patients with arthritis. The intensity of temperature delivered by the electric cushion should be placed on the first level (lowest level), to avoid discomfort to the patient. The electric cushion provides a continuous hour of regulated heat, with enough penetration to raise the external temperature of the area to 40-42 ° C, a temperature range at which facilitation of elimination of the virus is expected.

Conditions

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COVID-19 Thermotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The application of an electric chest pad. The use of an electric cushion was chosen because it is designed to be used in human thermal therapy. The electric cushion provides continuous 90 minutes of regulated heat, with enough penetration to raise the external temperature of the area to 40-42 ° C.

It is a therapy designed to detain disease progression. It is not expected to have an effect on concomitant microorganisms such as bacteria or opportunists such as Candida albicans, so that when the concomitant infection is suspected, the antibiotic of choice should be given or continued, depending on the nature of the infection.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thermotherapy

Electric heat pad applied in the thorax for 90 minutes, twice daily, for 5 days.

\+ Usual in-hospital care

Group Type EXPERIMENTAL

Electric pad for human external pain therapy

Intervention Type DEVICE

An electric pad for local heat production will be put on the back of the patient for two hours

Control

Usual in-hospital care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient with symptoms of COVID-19 (fever, headache, cough, sore throat, myalgias, arthralgias, shortness of breath, anosmia, fatigue, diarrhea, vomit, or conjunctivitis) meeting criteria for mild or moderate COVID-19 according to the following criteria:

1. 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.
2. 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.
2. Patient with less than or equal to 5 days from symptom onset
3. Participant understands the intervention and procedures and accepts randomization.

Exclusion Criteria

1. Suspected or confirmed pregnancy at evaluation
2. Severe decompensation of any of the patient's underlying diseases
3. Previous diagnosis of COVID-19 with complete resolution of symptoms for at least 2 days.
4. Patients meeting criteria for severe or critical COVID-19 at evaluation:

1. 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.
2. Critical COVID-19 - Patient with ARDS, shock, multiorgan failure, or any other condition requiring admission to an intensive care unit.

Elimination Criteria:

1. Participant retires consent to participate in the study
2. Patient requiring ≥4 L/min of supplementary oxygen in the 24 hours of hospitalization (in the case that randomization occurred in the first 24 hours of hospitalization)
3. Two negative tests against SARS-CoV-2 (a sequential diagnostic strategy will be implemented to reduce losses due to false negative tests).
4. Patient that do not tolerate thermotherapy and requests to stop receiving the intervention.
5. Transfer to another medical unit in the first 5 days of inclusion in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Norma del Carmen Galindo-Sevilla

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norma del Carmen Galindo Sevilla, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Perinatología

Javier Mancilla-Galindo, MBBS

Role: STUDY_DIRECTOR

Instituto Nacional de Cardiología

Locations

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Hospital Dr. Ángel Leaño

Guadalajara, Jalisco, Mexico

Site Status RECRUITING

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

Villahermosa, Tabasco, Mexico

Site Status RECRUITING

Unidad Temporal Movil COVID-19 Autódromo Hermanos Rodríguez IMSS

Mexico City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Norma del Carmen Galindo Sevilla, PhD

Role: CONTACT

[email protected]

+525539968217

Javier Mancilla-Galindo, MBBS

Role: CONTACT

[email protected]

Facility Contacts

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Juan Pablo Cuellar Robledo, MD

Role: primary

Alfonso Gutiérrez Padilla, MD

Role: backup

Julio César Robledo Pascual, MD

Role: primary

[email protected]

Víctor Manuel Narváez Osorio, MD

Role: backup

[email protected]

Javier Michael García Acosta, MD

Role: primary

[email protected]

Yanira Saralee Nava Serrano, MD, MSc

Role: backup

[email protected]

References

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Liu J, Zhang X, Zhang F, Hong N, Wang G, Wang A, Wang L. 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. BMC Genomics. 2015 Nov 16;16:945. doi: 10.1186/s12864-015-2126-8.

Reference Type BACKGROUND

PMID: 26573813 (View on PubMed)

Wang MR, Cui ZH, Li JW, Hao XY, Zhao L, Wang QC. In vitro thermotherapy-based methods for plant virus eradication. Plant Methods. 2018 Oct 6;14:87. doi: 10.1186/s13007-018-0355-y. eCollection 2018.

Reference Type BACKGROUND

PMID: 30323856 (View on PubMed)

Zhu LL, Gao XH, Qi R, Hong Y, Li X, Wang X, McHepange UO, Zhang L, Wei H, Chen HD. Local hyperthermia could induce antiviral activity by endogenous interferon-dependent pathway in condyloma acuminata. Antiviral Res. 2010 Nov;88(2):187-92. doi: 10.1016/j.antiviral.2010.08.012. Epub 2010 Aug 24.

Reference Type BACKGROUND

PMID: 20797409 (View on PubMed)

Mancilla-Galindo J, Kammar-Garcia A, Mendoza-Gertrudis ML, Garcia Acosta JM, Nava Serrano YS, Santiago O, Torres Vasquez MB, Martinez Martinez D, Fernandez-Urrutia LA, Robledo Pascual JC, Narvaez Morales ID, Velasco-Medina AA, Mancilla-Ramirez J, Figueroa-Damian R, Galindo-Sevilla N. Regional moderate hyperthermia for mild-to-moderate COVID-19 (TherMoCoV study): a randomized controlled trial. Front Med (Lausanne). 2023 Dec 22;10:1256197. doi: 10.3389/fmed.2023.1256197. eCollection 2023.

Reference Type DERIVED

PMID: 38188344 (View on PubMed)

Other Identifiers

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U1111-1250-7416

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Thermotherapy

Electric pad for human external pain therapy

Control

Interventions

Electric pad for human external pain therapy

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Direccion General de Calidad y Educacion en Salud

Instituto Mexicano del Seguro Social

Hospital Regional de Alta Especialidad Juan Graham Tabasco

Hospital Dr. Ángel Leaño

National Polytechnic Institute, Mexico

Universidad Juárez Autónoma de Tabasco

Instituto Nacional de Perinatologia

Responsible Party

Norma del Carmen Galindo-Sevilla

Principal Investigators

Norma del Carmen Galindo Sevilla, PhD

Javier Mancilla-Galindo, MBBS

Locations

Hospital Dr. Ángel Leaño

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

Unidad Temporal Movil COVID-19 Autódromo Hermanos Rodríguez IMSS

Countries

Central Contacts

Norma del Carmen Galindo Sevilla, PhD

Javier Mancilla-Galindo, MBBS

Facility Contacts

Juan Pablo Cuellar Robledo, MD

Alfonso Gutiérrez Padilla, MD

Julio César Robledo Pascual, MD

Víctor Manuel Narváez Osorio, MD

Javier Michael García Acosta, MD

Yanira Saralee Nava Serrano, MD, MSc

References

Wang MR, Cui ZH, Li JW, Hao XY, Zhao L, Wang QC. In vitro thermotherapy-based methods for plant virus eradication. Plant Methods. 2018 Oct 6;14:87. doi: 10.1186/s13007-018-0355-y. eCollection 2018.

Zhu LL, Gao XH, Qi R, Hong Y, Li X, Wang X, McHepange UO, Zhang L, Wei H, Chen HD. Local hyperthermia could induce antiviral activity by endogenous interferon-dependent pathway in condyloma acuminata. Antiviral Res. 2010 Nov;88(2):187-92. doi: 10.1016/j.antiviral.2010.08.012. Epub 2010 Aug 24.

Other Identifiers

U1111-1250-7416