Back to resultsLocal Thermotherapy for Patients With Mild-to-moderate COVID-19 (TherMoCoV)
Primary Purpose
COVID-19, Thermotherapy
Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Electric pad for human external pain therapy
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Hyperthermia
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
- Transfer to another medical unit in the first 5 days of inclusion in the study.
Sites / Locations
- Hospital Dr. Ángel LeañoRecruiting
- Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"Recruiting
- Unidad Temporal Movil COVID-19 Autódromo Hermanos Rodríguez IMSSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Thermotherapy
Control
Arm Description
Electric heat pad applied in the thorax for 90 minutes, twice daily, for 5 days. + Usual in-hospital care
Usual in-hospital care
Outcomes
Primary Outcome Measures
Progression of disease (composite outcome)
Progression to any of the following:
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.
Death
Secondary Outcome Measures
Mortality at day 15
Proportion of participants deceased by day 15 after enrollment
Mortality at day 28
Proportion of participants deceased by day 28 after enrollment
Time to progression to severe COVID-19
Days from symptom onset to progression to severe COVID-19
Time to progression to critical COVID-19
Days from symptom onset to progression to critical COVID-19
Hospitalization time
In-hospital stay in days
Percentage of participants at each clinical status in the Ordinal Scale at Day 15
Ordinal scale of 7 categories: 1) Not hospitalized, without limitations on daily activities; 2) Not hospitalized, with limitations on daily activities; 3) Hospitalized, not requiring supplementary oxygen; 4) Hospitalized, requiring low-flow supplementary oxygen; 5) Hospitalized, requiring supplementary oxygen with high-flow nasal cannula or non-invasive ventilation; 6) Hospitalized, under invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 7) Death
Percentage of participants at each clinical status in the Ordinal Scale at Day 28
Ordinal scale of 7 categories: 1) Not hospitalized, without limitations on daily activities; 2) Not hospitalized, with limitations on daily activities; 3) Hospitalized, not requiring supplementary oxygen; 4) Hospitalized, requiring low-flow supplementary oxygen; 5) Hospitalized, requiring supplementary oxygen with high-flow nasal cannula or non-invasive ventilation; 6) Hospitalized, under invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 7) Death
Time (days) to last requiring supplementary oxygen according to modality
Modalities: 1) Simple nasal cannula or face mask; 2) Face mask with reservoir; 3) High-flow nasal cannula; 4) Non-invasive mechanical ventilation; 5) Invasive mechanical ventilation
Change in National Early Warning Score 2 (NEWS-2) with respect to baseline
Change in the National Early Warning Score 2 (NEWS-2) with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
This score evaluates 7 parameters (respiratory rate, peripheral arterial oxygen saturation, supplementary oxygen requirements, systolic arterial blood pressure, heart rate, consciousness, and body temperature). Assigned values for every parameter may range from 0 to 3 points, except for supplementary oxygen for which possible values are 0 (not requiring supplementary oxygen) and 2 (requiring supplementary oxygen). The total sum of points for this score may range from 0 to 20 points. Higher scores reflect increasing clinical deterioration.
Proportion of patients requiring invasive mechanical ventilation
Proportion of patients requiring invasive mechanical ventilation during the entire follow-up period
Proportion of patients requiring admission to intensive care unit (ICU)
Proportion of patients requiring admission to intensive care unit (ICU) during the entire follow-up period
Time to requiring invasive mechanical ventilation
Days from symptom onset to progression to requiring invasive mechanical ventilation
Time to requiring admission to intensive care unit (ICU)
Days from symptom onset to requiring admission to intensive care unit (ICU)
Proportion of patients with adverse events according to outcome
Severe: Causes death of the patient, puts the patient's life at risk in the moment of occurrence, requires hospitalization or prolongs hospitalization, causes persistent or significant disability.
Non-severe adverse events: Do not meet the previously outlined criteria.
Proportion of patients with adverse events according to severity
Mild (Grade 1): Present with easily tolerated signs and symptoms, do not need specific treatment, do not prolong hospitalization, nor require suspension of the intervention
Moderate (Grade 2): Interfere with daily activities (school or work), do not directly threaten life, require specific pharmacological treatment, and do not necessarily require suspension of the intervention.
Severe (Grades 3, 4, and 5): Interfere with daily activities (school and work), require pharmacological treatment and suspension of the intervention.
Proportion of patients with adverse events according to causality
Certain
Probable
Possible
Uncertain
Unclassifiable
Proportion of patients tolerating the intervention (no comparison)
Proportion of patients tolerating the intervention (number of sessions and minutes per session).
Full Information
NCT ID
NCT04363541
First Posted
April 23, 2020
Last Updated
November 3, 2020
Sponsor
Instituto Nacional de Perinatologia
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT04363541
Brief Title
Local Thermotherapy for Patients With Mild-to-moderate COVID-19
Acronym
TherMoCoV
Official Title
A Multicenter, Open-label, Parallel-group, Randomized, Adaptive Trial to Evaluate Local Thermotherapy in Patients With Mild-to-moderate COVID-19, to Prevent Disease Progression
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Perinatologia
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Thermotherapy
Keywords
SARS-CoV-2, Hyperthermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
274 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thermotherapy
Arm Type
Experimental
Arm Description
Electric heat pad applied in the thorax for 90 minutes, twice daily, for 5 days.
+ Usual in-hospital care
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual in-hospital care
Intervention Type
Device
Intervention Name(s)
Electric pad for human external pain therapy
Intervention Description
An electric pad for local heat production will be put on the back of the patient for two hours
Primary Outcome Measure Information:
Title
Progression of disease (composite outcome)
Description
Progression to any of the following:
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.
Death
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Mortality at day 15
Description
Proportion of participants deceased by day 15 after enrollment
Time Frame
15 days
Title
Mortality at day 28
Description
Proportion of participants deceased by day 28 after enrollment
Time Frame
28 days
Title
Time to progression to severe COVID-19
Description
Days from symptom onset to progression to severe COVID-19
Time Frame
Up to 33 days
Title
Time to progression to critical COVID-19
Description
Days from symptom onset to progression to critical COVID-19
Time Frame
Up to 33 days
Title
Hospitalization time
Description
In-hospital stay in days
Time Frame
Up to 33 days
Title
Percentage of participants at each clinical status in the Ordinal Scale at Day 15
Description
Ordinal scale of 7 categories: 1) Not hospitalized, without limitations on daily activities; 2) Not hospitalized, with limitations on daily activities; 3) Hospitalized, not requiring supplementary oxygen; 4) Hospitalized, requiring low-flow supplementary oxygen; 5) Hospitalized, requiring supplementary oxygen with high-flow nasal cannula or non-invasive ventilation; 6) Hospitalized, under invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 7) Death
Time Frame
15 days
Title
Percentage of participants at each clinical status in the Ordinal Scale at Day 28
Description
Ordinal scale of 7 categories: 1) Not hospitalized, without limitations on daily activities; 2) Not hospitalized, with limitations on daily activities; 3) Hospitalized, not requiring supplementary oxygen; 4) Hospitalized, requiring low-flow supplementary oxygen; 5) Hospitalized, requiring supplementary oxygen with high-flow nasal cannula or non-invasive ventilation; 6) Hospitalized, under invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 7) Death
Time Frame
28 days
Title
Time (days) to last requiring supplementary oxygen according to modality
Description
Modalities: 1) Simple nasal cannula or face mask; 2) Face mask with reservoir; 3) High-flow nasal cannula; 4) Non-invasive mechanical ventilation; 5) Invasive mechanical ventilation
Time Frame
28 days
Title
Change in National Early Warning Score 2 (NEWS-2) with respect to baseline
Description
Change in the National Early Warning Score 2 (NEWS-2) with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
This score evaluates 7 parameters (respiratory rate, peripheral arterial oxygen saturation, supplementary oxygen requirements, systolic arterial blood pressure, heart rate, consciousness, and body temperature). Assigned values for every parameter may range from 0 to 3 points, except for supplementary oxygen for which possible values are 0 (not requiring supplementary oxygen) and 2 (requiring supplementary oxygen). The total sum of points for this score may range from 0 to 20 points. Higher scores reflect increasing clinical deterioration.
Time Frame
Days 1, 5, 15, and 28
Title
Proportion of patients requiring invasive mechanical ventilation
Description
Proportion of patients requiring invasive mechanical ventilation during the entire follow-up period
Time Frame
28 days
Title
Proportion of patients requiring admission to intensive care unit (ICU)
Description
Proportion of patients requiring admission to intensive care unit (ICU) during the entire follow-up period
Time Frame
28 days
Title
Time to requiring invasive mechanical ventilation
Description
Days from symptom onset to progression to requiring invasive mechanical ventilation
Time Frame
Up to 33 days
Title
Time to requiring admission to intensive care unit (ICU)
Description
Days from symptom onset to requiring admission to intensive care unit (ICU)
Time Frame
Up to 33 days
Title
Proportion of patients with adverse events according to outcome
Description
Severe: Causes death of the patient, puts the patient's life at risk in the moment of occurrence, requires hospitalization or prolongs hospitalization, causes persistent or significant disability.
Non-severe adverse events: Do not meet the previously outlined criteria.
Time Frame
28 days
Title
Proportion of patients with adverse events according to severity
Description
Mild (Grade 1): Present with easily tolerated signs and symptoms, do not need specific treatment, do not prolong hospitalization, nor require suspension of the intervention
Moderate (Grade 2): Interfere with daily activities (school or work), do not directly threaten life, require specific pharmacological treatment, and do not necessarily require suspension of the intervention.
Severe (Grades 3, 4, and 5): Interfere with daily activities (school and work), require pharmacological treatment and suspension of the intervention.
Time Frame
28 days
Title
Proportion of patients with adverse events according to causality
Description
Certain
Probable
Possible
Uncertain
Unclassifiable
Time Frame
28 days
Title
Proportion of patients tolerating the intervention (no comparison)
Description
Proportion of patients tolerating the intervention (number of sessions and minutes per session).
Time Frame
5 days
Other Pre-specified Outcome Measures:
Title
Comparison of laboratory parameters with respect to baseline (units: 10^3/microliter)
Description
Change in laboratory parameters with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
Parameters to be included are: total leucocytes, neutrophils, lymphocytes, monocytes, and platelets
Time Frame
Days 1, 5, 15, and 28
Title
Comparison of laboratory parameters with respect to baseline (units: milligrams/deciliter)
Description
Change in laboratory parameters with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
Parameters to be included are: glucose, urea, blood urea nitrogen, creatinine, total bilirubin, direct bilirubin, and indirect bilirubin.
Time Frame
Days 1, 5, 15, and 28
Title
Comparison of laboratory parameters with respect to baseline (units: grams/deciliter)
Description
Change in laboratory parameters with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
Parameters to be included are: hemoglobin, and albumin
Time Frame
Days 1, 5, 15, and 28
Title
Comparison of laboratory parameters with respect to baseline (units: milligrams/liter)
Description
Change in laboratory parameters with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
Parameters to be included are: C-reactive protein
Time Frame
Days 1, 5, 15, and 28
Title
Comparison of laboratory parameters with respect to baseline (units: nanograms/milliliter)
Description
Change in laboratory parameters with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
Parameters to be included are: D-dimer, and procalcitonin
Time Frame
Days 1, 5, 15, and 28
Title
Comparison of laboratory parameters with respect to baseline (units: International Units/liter)
Description
Change in laboratory parameters with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
Parameters to be included are: aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), and creatinine phosphokinase (CPK).
Time Frame
Days 1, 5, 15, and 28
Title
Comparison of laboratory parameters with respect to baseline (ratio: no units)
Description
Change in laboratory parameters with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
Parameters to be included are: neutrophil-to-lymphocyte ratio, and international normalized ratio (INR).
Time Frame
Days 1, 5, 15, and 28
Title
Comparison of laboratory parameters with respect to baseline (units: percent)
Description
Change in laboratory parameters with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
Parameters to be included are: hematocrit
Time Frame
Days 1, 5, 15, and 28
Title
Comparison of laboratory parameters with respect to baseline (units: seconds)
Description
Change in laboratory parameters with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
Parameters to be included are: prothrombin time (PT), and partial thromboplastin time (PTT)
Time Frame
Days 1, 5, 15, and 28
Title
Comparison of laboratory parameters with respect to baseline (units: millimeters/hour)
Description
Change in laboratory parameters with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
Parameters to be included are: erythrocyte sedimentation rate (ESR)
Time Frame
Days 1, 5, 15, and 28
Title
Comparison of cytokine levels with respect to baseline
Description
Change in cytokine levels with respect to baseline (Day 1), measured at day 5 for all patients, and days 15 & 28 only for patients that remain hospitalized.
Time Frame
Days 1, 5, 15, and 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Transfer to another medical unit in the first 5 days of inclusion in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Norma del Carmen Galindo Sevilla, PhD
Phone
+525539968217
Email
ngalindosevilla@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Mancilla-Galindo, MBBS
Email
javimangal@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norma del Carmen Galindo Sevilla, PhD
Organizational Affiliation
Instituto Nacional de Perinatología
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Mancilla-Galindo, MBBS
Organizational Affiliation
Instituto Nacional de Cardiología
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Dr. Ángel Leaño
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45200
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Pablo Cuellar Robledo, MD
First Name & Middle Initial & Last Name & Degree
Alfonso Gutiérrez Padilla, MD
First Name & Middle Initial & Last Name & Degree
Juan Pablo Cuellar Robledo, MD
First Name & Middle Initial & Last Name & Degree
Alfonso Gutiérrez Padilla, MD
Facility Name
Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
City
Villahermosa
State/Province
Tabasco
ZIP/Postal Code
86126
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio César Robledo Pascual, MD
Email
jrobledopascual@yahoo.com
First Name & Middle Initial & Last Name & Degree
Víctor Manuel Narváez Osorio, MD
Email
vnarvaezosorio@hotmail.com
First Name & Middle Initial & Last Name & Degree
Julio César Robledo Pascual, MD
First Name & Middle Initial & Last Name & Degree
Víctor Manuel Narváez Osorio, MD
First Name & Middle Initial & Last Name & Degree
Iván Daniel Narváez Morales, MBBS
Facility Name
Unidad Temporal Movil COVID-19 Autódromo Hermanos Rodríguez IMSS
City
Mexico City
ZIP/Postal Code
08400
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Michael García Acosta, MD
Email
michxal1@gmail.com
First Name & Middle Initial & Last Name & Degree
Yanira Saralee Nava Serrano, MD, MSc
Email
male.sevilla.25@gmail.com
First Name & Middle Initial & Last Name & Degree
Javier Michael García Acosta, MD
First Name & Middle Initial & Last Name & Degree
Yanira Saralee Nava Serrano, MD, MSc
First Name & Middle Initial & Last Name & Degree
Óscar Santiago Martínez, MSc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26573813
Citation
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.
Results Reference
background
PubMed Identifier
30323856
Citation
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.
Results Reference
background
PubMed Identifier
20797409
Citation
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.
Results Reference
background
Learn more about this trial
Local Thermotherapy for Patients With Mild-to-moderate COVID-19
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