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

NCT04363541 | Recruiting FDA Device

• 1 other identifier: U1111-1250-7416
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

SARS-CoV-2; Hyperthermia

Outcome Measures

Primary Outcomes (1)

• Progression of disease (composite outcome)

  Progression to any of the following: 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. 3. Death

  28 days

Secondary Outcomes (17)

• Mortality at day 15

  15 days

• Mortality at day 28

  28 days

• Time to progression to severe COVID-19

  Up to 33 days

• Time to progression to critical COVID-19

  Up to 33 days

• Hospitalization time

  Up to 33 days

Other Outcomes (11)

• Comparison of laboratory parameters with respect to baseline (units: 10^3/microliter)

  Days 1, 5, 15, and 28

• Comparison of laboratory parameters with respect to baseline (units: milligrams/deciliter)

  Days 1, 5, 15, and 28

• Comparison of laboratory parameters with respect to baseline (units: grams/deciliter)

  Days 1, 5, 15, and 28

Study Arms (2)

Thermotherapy

EXPERIMENTAL

Electric heat pad applied in the thorax for 90 minutes, twice daily, for 5 days. \+ Usual in-hospital care

Device: Electric pad for human external pain therapy

Control

NO INTERVENTION

Usual in-hospital care

Interventions

Electric pad for human external pain therapy DEVICE

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

Thermotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Suspected or confirmed pregnancy at evaluation
• Severe decompensation of any of the patient's underlying diseases
• Previous diagnosis of COVID-19 with complete resolution of symptoms for at least 2 days.
• Patients meeting criteria for severe or critical COVID-19 at evaluation:
• 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.
• Critical COVID-19 - Patient with ARDS, shock, multiorgan failure, or any other condition requiring admission to an intensive care unit.
• Elimination Criteria:
• Participant retires consent to participate in the study
• 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)
• Two negative tests against SARS-CoV-2 (a sequential diagnostic strategy will be implemented to reduce losses due to false negative tests).
• Patient that do not tolerate thermotherapy and requests to stop receiving the intervention.

Sponsors & Collaborators

• Instituto Nacional de Perinatologia: lead
• Direccion General de Calidad y Educacion en Salud: collaborator
• Instituto Mexicano del Seguro Social: collaborator
• Hospital Regional de Alta Especialidad Juan Graham Tabasco: collaborator
• Hospital Dr. Ángel Leaño: collaborator
• National Polytechnic Institute, Mexico: collaborator
• Universidad Juárez Autónoma de Tabasco: collaborator

Study Sites (3)

Hospital Dr. Ángel Leaño

Guadalajara, Jalisco, 45200, Mexico

RECRUITING

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

Villahermosa, Tabasco, 86126, Mexico

RECRUITING

Unidad Temporal Movil COVID-19 Autódromo Hermanos Rodríguez IMSS

Mexico City, 08400, Mexico

RECRUITING

Related Publications (4)

• 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.

  PMID: 26573813 BACKGROUND

• 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.

  PMID: 30323856 BACKGROUND

• 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.

  PMID: 20797409 BACKGROUND

• 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.

  PMID: 38188344 DERIVED

MeSH Terms

Conditions

COVID-19; Hyperthermia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Norma del Carmen Galindo Sevilla, PhD

  Instituto Nacional de Perinatología

  PRINCIPAL INVESTIGATOR

• Javier Mancilla-Galindo, MBBS

  Instituto Nacional de Cardiología

  STUDY DIRECTOR

Central Study Contacts

Norma del Carmen Galindo Sevilla, PhD

CONTACT

+525539968217; ngalindosevilla@gmail.com

Javier Mancilla-Galindo, MBBS

CONTACT

javimangal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: August 27, 2020
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

ME (3)