Status:
RECRUITING
Local Thermotherapy for Patients With Mild-to-moderate COVID-19
Lead Sponsor:
Instituto Nacional de Perinatologia
Collaborating Sponsors:
Direccion General de Calidad y Educacion en Salud
Instituto Mexicano del Seguro Social
Conditions:
COVID-19
Thermotherapy
Eligibility:
All Genders
18+ years
Phase:
NA
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, there...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT04363541
Start Date
August 27 2020
End Date
June 1 2022
Last Update
November 5 2020
Active Locations (3)
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1
Hospital Dr. Ángel Leaño
Guadalajara, Jalisco, Mexico, 45200
2
Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
Villahermosa, Tabasco, Mexico, 86126
3
Unidad Temporal Movil COVID-19 Autódromo Hermanos Rodríguez IMSS
Mexico City, Mexico, 08400