Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Health condition(s) code:
Coronavirus Infections
SARS Virus
Coronaviridae Infections
Betacoronavirus
Health condition keyword:
Intervention(s):
Patients treated at home:
Group I (experimental 1): Nebulization with Homeostec (5 ml) + Paracetamol (500 mg). The patient will receive a bottle with 5 ml of Homeostec (electrolysed solution with neutral pH), which will be placed in the nebulizer container. The patient will receive sprays for 15 min, four times a day for 7 days. In addition, you can take Paracetamol 500 mg (orally) every 6 hours. Other medications may be added at the discretion of the treating physician as deemed necessary for the patient.
Group II (experimental 2): Nebulization with Homeostec (5 ml) + Paracetamol (500 mg) + Homeostec intravenously (15 ml, with dose escalation). The patient will receive a bottle with 5 ml of Homeostec (neutral pH electrolyzed solution), which will be placed in the nebulizer container. The patient will receive sprays for 15 min, four times a day for 7 days. Additionally, 15 ml of Homeostec will be administered intravenously loaded in a 20 ml syringe. The solution will be applied to an arm vein using a butterfly-type IV application catheter connected to the syringe, in a period of 1 to 2 min, once every 24 hours for 7 days, by research personnel who will visit the patient in his home. The initial intravenous dose of 15ml per day will have successive increments, before reaching dose-limiting toxicity, or until a dose was found that prevented disease progression. In addition, you can take Paracetamol 500 mg (orally) every 6 hours. Other medications may be added at the discretion of the treating physician as deemed necessary for the patient.
Group III (control 1, usual medical care): Paracetamol (500 mg). The patient will receive Paracetamol 500 mg (orally) every 6 hours. Other medications may be added at the discretion of the treating physician as deemed necessary for the patient. For group I and II: If there is nausea, vomiting and / or diarrhea, 30 ml of oral Homeostec is added, 4 times a day, for as long as symptoms lasted, plus 2 more days after symptoms disappeared. In patients with oropharyngeal ulcerations (causing intense throat pain), the indication is to gargle with 10 ml of Homeostec, 6 times a day, and swallow the solution after gargling with it. This is done for the number of days necessary for the pain to decrease.
Hospitalized patients (Includes patients on a regular floor or intensive care unit, with or without mechanical ventilation):
Group IV (experimental 3): Homeostec intravenously (maximum dose achieved in dose escalation in patients treated at home) + usual medical care. The patient will receive Homeostec (pH neutral electrolyzed solution) intravenously. The solution will be applied for 14 days, or until improvement, progression or toxicity. Other medications may be added at the discretion of the treating physician as deemed necessary for the patient.
Group V (control 2): 0.9% physiological solution (placebo, same amount of solution applied to group IV) l) + usual medical care. The patient will receive 0.9% Physiological Solution intravenously. The solution will be applied for 14 days, or until improvement, progression or toxicity. Other medications may be added at the discretion of the treating physician as deemed necessary for the patient.
Intervention code:
Saline Solution
Acetaminophen
Tablets
Administration, Intravenous
Administration, Oral
Administration, Inhalation