Clinical trial: Local Thermotherapy for Patients With Mild-to-moderate COVID-19 (NCT04363541)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment