Using heat therapy to treat mild-to-moderate COVID-19

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

This study is testing if using heat therapy with an electric pad can help high-risk patients with mild-to-moderate COVID-19 feel better and stop the virus from spreading in their bodies.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 274 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Instituto Nacional de Perinatologia (Government)
• Locations: 3 sites (Guadalajara, Jalisco and 2 other locations)
• Trial ID: NCT04363541 on ClinicalTrials.gov

What this trial studies

This study investigates the use of local thermotherapy as a treatment for patients with mild-to-moderate COVID-19. The approach involves applying regulated heat using an electric chest pad to raise the temperature of the affected area, which may help inhibit the replication of the SARS-CoV-2 virus. The intervention is aimed at high-risk patients and is intended to be used as an adjuvant therapy to prevent the progression of the disease. The study will assess the safety and efficacy of this method in alleviating symptoms and reducing viral load.

Who should consider this trial

Good fit: Ideal candidates include individuals with mild-to-moderate COVID-19 symptoms who have experienced symptoms for five days or less.

Not a fit: Patients with severe or critical COVID-19, or those who do not meet the inclusion criteria, are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel, non-invasive method to manage COVID-19 symptoms and reduce the severity of the disease.

How similar studies have performed: While the use of thermotherapy is a novel approach for treating COVID-19, similar methods have shown promise in other viral infections, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Guadalajara, Jalisco and 2 other locations

• Hospital Dr. Ángel Leaño — Guadalajara, Jalisco, Mexico (Recruiting)
• Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus" — Villahermosa, Tabasco, Mexico (Recruiting)
• Unidad Temporal Movil COVID-19 Autódromo Hermanos Rodríguez IMSS — Mexico City, Mexico (Recruiting)

Study contacts

• Principal investigator: Norma del Carmen Galindo Sevilla, PhD — Instituto Nacional de Perinatologia
• Study coordinator: Norma del Carmen Galindo Sevilla, PhD

Conditions COVID-19; Thermotherapy; SARS-CoV-2; Hyperthermia