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 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.

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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

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

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