Home | Therapy for COVID-19-Phase I-II
29 August 2020 - 9:58am by SSA23 March 2023 - 1:44pm by SSA
Changes to Recruitment status
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Recruiting
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Complete
Changes to Primary outcome(s)
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Disease progression (present or absent). Measurement time: Daily until 14th day.
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Disease progression (present or absent). Measurement time: Daily until 20th day or until patient outcome (cure or progression).
 
Patients treated at home. The progression will be present when hospitalization or death occurs.
 
Patients treated at home. The progression will be present when hospitalization or death occurs.
 
In hospitalized patients: The progression will be present when they are in the usual hospital floor and without a ventilator, progression is considered when there is death or admission to the Intensive Care Unit (ICU) or requiring mechanical ventilation.
 
In hospitalized patients: The progression will be present when they are in the usual hospital floor and without a ventilator, progression is considered when there is death or admission to the Intensive Care Unit (ICU) or requiring mechanical ventilation.
 
Patients enrolled in the trial after admission to the ICU or already on mechanical ventilation. The progression will be present when death occurred.
 
Patients enrolled in the trial after admission to the ICU or already on mechanical ventilation. The progression will be present when death occurred.
Changes to Key secondary outcomes
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Adverse Events-AE (Present or Absent. AE will be classified according to the "Common Terminology Criteria for Adverse Events (CTCAE) version 5). Measurement time: Daily until 14th day.
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Adverse Events-AE (Present or Absent. AE will be classified according to the "Common Terminology Criteria for Adverse Events (CTCAE) version 5). Measurement time: Daily until 20th day or until patient outcome (cure or death).
 
Change in laboratory test values (Dimero D, C-reactive protein, fibrinogen and erythrocyte sedimentation rate). Measurement time: Basal, at 2, 4, 6 and 14 days.
 
Change in laboratory test values (Dimero D, C-reactive protein, fibrinogen and erythrocyte sedimentation rate). Measurement time: Basal, at 2, 4, 6 and 14 days.
Changes to Intervention(s)
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Patients treated at home:
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Patients treated at home:
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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.
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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.
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Group II (experimental 2): Nebulization with Homeostec (5 ml) + Paracetamol (500 mg) + Homeostec (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.
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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.
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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.
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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.
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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
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Hospitalized patients (Includes patients on a regular floor or intensive care unit, with or without mechanical ventilation):
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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.
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Hospitalized patients (Includes patients on a regular floor or intensive care unit, with or without mechanical ventilation):
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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.
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Group IV (experimental 3): Homeostec (15 ml, with dose escalation) + Paracetamol (500 mg). The patient will receive 15 ml of Homeostec (pH neutral electrolyzed solution) intravenously loaded into a 20 ml syringe. The solution will be applied via a butterfly-type IV application catheter connected to the syringe, within 1 to 2 min once every 12 hours 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.
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Group V (control 2): 0.9% physiological solution (15 ml) + Paracetamol (500 mg). The patient will receive 15 ml of 0.9% Physiological Solution intravenously loaded into a 20 ml syringe. The solution will be applied via a butterfly-type IV application catheter connected to the syringe, within 1 to 2 min once every 12 hours for 7 days. In addition, you 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.
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Changes to Final enrolment number
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270
Changes to Study completion date
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2021-01-15T00:00:00
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2021-04-30T00:00:00
Changes to Date of first publication
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2021-12-01T00:00:00
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2020-09-10T00:00:00
Changes to Masking
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Single Blind
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Open
Changes to Target sample size
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100
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200
Changes to Record Verification Date
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2020/08/29
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2023/03/23
Changes to Next update date
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2021/08/29
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2024/03/23
Changes to Secondary sponsor
 
Medical School of the University of Colima, Mexico.
 
Medical School of the University of Colima, Mexico.
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COVID-19 respiratory care clinic INSABI N. 20 Poliforum/SEDENA Chiapas, Mexico
Changes to Results file
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sites/default/files/etm_22_3_10347_PDF (15).pdf
Changes to Url for Results File
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https://www.spandidos-publications.com/10.3892/etm.2021.10347
Revision of 23 March 2023 - 1:44pm: