About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

274 Participants

are divided into 2 treatment groups

Group A: ThermotherapyExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

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

Time frame

28 days

Secondary outcomes

1

Mortality at day 15

Proportion of participants deceased by day 15 after enrollment

Time frame

15 days

2

Mortality at day 28

Proportion of participants deceased by day 28 after enrollment

Time frame

28 days

3

Time to progression to severe COVID-19

Days from symptom onset to progression to severe COVID-19

Time frame

Up to 33 days

4

Time to progression to critical COVID-19

Days from symptom onset to progression to critical COVID-19

Time frame

Up to 33 days

Other outcomes

1

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

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

2

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

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

3

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

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

4

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

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

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts