COVID-19TherMoCoVNCT04363541
Local Thermotherapy for Patients With Mild-to-moderate COVID-19
A study testing Electric pad for human external pain therapy in people with COVID-19 and Thermotherapy, run by Instituto Nacional de Perinatologia at 3 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Thermotherapy
- What is being tested?
- Electric pad for human external pain therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 3 sitesMexico
- Study dates
- 27 Aug 2020to Jun 2022
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Javier Mancilla-Galindo, MBBS contact
Mexico3 sites, 3 recruiting
- Recruiting
Hospital Dr. Ángel Leaño
Guadalajara, Jalisco, 45200
Juan Pablo Cuellar Robledo, MD
Alfonso Gutiérrez Padilla, MD
- Recruiting
Unidad Temporal Movil COVID-19 Autódromo Hermanos Rodríguez IMSS
Mexico City, 08400
Javier Michael García Acosta, MD, michxal1@gmail.com
Yanira Saralee Nava Serrano, MD, MSc, male.sevilla.25@gmail.com
- Recruiting
Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
Villahermosa, Tabasco, 86126
Julio César Robledo Pascual, MD, jrobledopascual@yahoo.com
Víctor Manuel Narváez Osorio, MD, vnarvaezosorio@hotmail.com
About this study
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
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.
Read the 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.
- Conditions
- COVID-19, Thermotherapy
- Being tested
- Electric pad for human external pain therapy
- Keywords
- SARS-CoV-2, Hyperthermia
- Medical subject headings
- COVID-19, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric pad for human external pain therapyDevice
An electric pad for local heat production will be put on the back of the patient for two hours
| Study group | Role | What they receive |
|---|---|---|
| Thermotherapy | Experimental | Electric heat pad applied in the thorax for 90 minutes, twice daily, for 5 days.
+ Usual in-hospital care Receives: Device: Electric pad for human external pain therapy |
| Control | No intervention | Usual in-hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (17)
Mortality at day 15
Proportion of participants deceased by day 15 after enrollment
Measured: 15 days
Mortality at day 28
Proportion of participants deceased by day 28 after enrollment
Measured: 28 days
Time to progression to severe COVID-19
Days from symptom onset to progression to severe COVID-19
Measured: Up to 33 days
Time to progression to critical COVID-19
Days from symptom onset to progression to critical COVID-19
Measured: Up to 33 days
Hospitalization time
In-hospital stay in days
Measured: Up to 33 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
Measured: 15 days
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
Measured: 28 days
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
Measured: 28 days
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.
Measured: Days 1, 5, 15, and 28
Proportion of patients requiring invasive mechanical ventilation
Proportion of patients requiring invasive mechanical ventilation during the entire follow-up period
Measured: 28 days
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
Measured: 28 days
Time to requiring invasive mechanical ventilation
Days from symptom onset to progression to requiring invasive mechanical ventilation
Measured: Up to 33 days
Time to requiring admission to intensive care unit (ICU)
Days from symptom onset to requiring admission to intensive care unit (ICU)
Measured: Up to 33 days
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.
Measured: 28 days
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.
Measured: 28 days
Proportion of patients with adverse events according to causality
- Certain
- Probable
- Possible
- Uncertain
- Unclassifiable
Measured: 28 days
Proportion of patients tolerating the intervention (no comparison)
Proportion of patients tolerating the intervention (number of sessions and minutes per session).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start27 Aug 2020
- Primary completionApr 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia
- Sponsor type
- Other government
- 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
- Responsible party
- Principal investigator, Norma del Carmen Galindo-Sevilla, Instituto Nacional de Perinatologia
- Investigators
- Norma del Carmen Galindo Sevilla, PhD, Principal investigator, Instituto Nacional de PerinatologiaJavier Mancilla-Galindo, MBBS, Study director, Instituto Nacional de Cardiología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363541
- Sponsor's protocol ID
- U1111-1250-7416
- Acronym
- TherMoCoV
- Status last verified
- Nov 2020
- First submitted
- 23 Apr 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 26573813Wang 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.
PubMed 30323856Zhu 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.
PubMed 20797409Mancilla-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.
PubMed 38188344
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04363541
- Acronym / sponsor ID
- TherMoCoV / U1111-1250-7416
- Conditions
- COVID-19, Thermotherapy
- Keywords
- SARS-CoV-2, Hyperthermia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Instituto Nacional de PerinatologiaOther government
- 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
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Thermotherapy | Experimental | Device: Electric pad for human external pain therapyElectric heat pad applied in the thorax for 90 minutes, twice daily, for 5 days. + Usual in-hospital care |
| Control | No intervention | –Usual in-hospital care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Patient with less than or equal to 5 days from symptom onset
- Participant understands the intervention and procedures and accepts randomization.
Key exclusion criteria (12 listed)
- 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:
- Participant retires consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electric pad for human external pain therapyAn electric pad for local heat production will be put on the back of the patient for two hours | Device | Thermotherapy |
Primary outcome
Progression of disease (composite outcome)
Time frame: 28 days
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
17 secondary outcomes
Mortality at day 15
Time frame: 15 days
Mortality at day 28
Time frame: 28 days
Time to progression to severe COVID-19
Time frame: Up to 33 days
Time to progression to critical COVID-19
Time frame: Up to 33 days
Hospitalization time
Time frame: Up to 33 days
Percentage of participants at each clinical status in the Ordinal Scale at Day 15
Time frame: 15 days
Percentage of participants at each clinical status in the Ordinal Scale at Day 28
Time frame: 28 days
Time (days) to last requiring supplementary oxygen according to modality
Time frame: 28 days
Change in National Early Warning Score 2 (NEWS-2) with respect to baseline
Time frame: Days 1, 5, 15, and 28
Proportion of patients requiring invasive mechanical ventilation
Time frame: 28 days
Proportion of patients requiring admission to intensive care unit (ICU)
Time frame: 28 days
Time to requiring invasive mechanical ventilation
Time frame: Up to 33 days
Time to requiring admission to intensive care unit (ICU)
Time frame: Up to 33 days
Proportion of patients with adverse events according to outcome
Time frame: 28 days
Proportion of patients with adverse events according to severity
Time frame: 28 days
Proportion of patients with adverse events according to causality
Time frame: 28 days
Proportion of patients tolerating the intervention (no comparison)
Time frame: 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Background: PubMed 26573813Liu 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.
- Background: PubMed 30323856Wang 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.
- Background: PubMed 20797409Zhu 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.
- Derived from this study: PubMed 38188344Mancilla-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Javier Mancilla-Galindo, MBBS contact
Norma del Carmen Galindo Sevilla, PhD principal investigator
Instituto Nacional de Perinatologia
Javier Mancilla-Galindo, MBBS study director
Instituto Nacional de Cardiología
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric pad for human external pain therapy in people with COVID-19 and Thermotherapy, run by Instituto Nacional de Perinatologia at 3 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norma del Carmen Galindo Sevilla, PhD (+525539968217, ngalindosevilla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of disease (composite outcome) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04363541, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.