Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment
Condition: Covid19
MeSH terms: COVID-19
Intervention: Azithromycin / Ivermectin / Ribaroxaban / Paracetamol; Azithromycin / Ribaroxaban / Paracetamol
Intervention description: In the patient with the presence of COVID-19 confirmed by the PCR-COVID-19 positive test, the drug is randomly assigned to belong to group A of Azithromycin / Ivermectin / Ribaroxaban / Paracetamol to be followed for 14 days by video call (approximately 15 to 20 min per day) to the patient and the presence or absence of clinical symptoms, adverse reactions being recorded daily; In the patient with the presence of COVID-19 confirmed by the PCR-COVID-19 positive test, the drug is randomly assigned to belong to group B of Azithromycin / Ribaroxaban / Paracetamol, to be followed for 14 days by video call (approximately 15 to 20 min per day) to the patient and the presence or absence of clinical symptoms, adverse reactions being recorded daily
Intervention MeSH terms: Acetaminophen; Azithromycin; Ivermectin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups of patients with COVID-19 will be integrated, a Group A taking the following medications: Paracetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C, Azithromycin tablets of 500 mg will take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days, Ivermectin tablets of 200mcg which will be calculated according to your weight and dose, it will be every 24 hours for 2 days and Rivaroxaban 10 mg tablets will take 1 every 24 hours for 10 days and a Group B will take Paracetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C, Azithromycin tablets of 500 mg will take 1 single dose tablet on the first day and then half a tablet orally every 24 hours for 4 days and Rivaroxaban 10 mg tablets will take 1 every 24 hours for 10 days.
Masking: Single (Participant)
Masking description: For the conformation of the groups, random numbers generated by lottery will be used in which the patient will take a piece of paper as he arrives and will have the number of the group to which he will be assigned. With a type of block randomization, A (Azithromycin, paracetamol, Ivermectin, and Ribaroxaban) and B (paracetamol, Azithromycin, and Ribaroxaban).
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The present study is designed for patients with mild COVID-19 phase, to demonstrate if there
      is a modification in the clinical evolution greater than or equal to 25% in their symptoms,
      implemented in two groups of patients under an early intervention treatment, a group ( A)
      will receive Azithromycin / Ivermectin / Ribaroxaban / Paracetamol and another group (B) will
      receive Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients Eligible for Family Medicine Unit No.20 and Family Medicine Unit No.13
             belonging to the North DF of the IMSS.

          -  Male and female patients

          -  Patients over 18 years of age.

          -  Patients with compliance with the operational definition COVID-19 and confirmatory
             test of P.C.R. positive within the first days of the illness (that are evaluated in
             first level of medical attention).

          -  Patients with comorbidities such as Type 2 Diabetes Mellitus, Systemic Arterial
             Hypertension, Overweight or Obesity.

          -  That they agree to sign an informed consent

             - Related to Video Call:

          -  That the Family Medicine Unit No.20 and the Family Medicine Unit No.13 belonging to
             the North DF of the IMSS have the Installation of Electronic Equipment for Internet
             use

        Exclusion Criteria:

          -  Severe COVID-19 patients (Ameriten sent immediately to second level of care, hospital)
             Patients with any Personal Pathological History of Hematological Diseases. • Patients
             allergic to macrolides (Azithromycin) and Ivermectin.