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Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment

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ClinicalTrials.gov Identifier: NCT04673214
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 22, 2020
Sponsor:
Collaborator:
Coordinación de Investigación en Salud, Mexico
Information provided by (Responsible Party):
Gilberto Cruz Arteaga, Coordinación de Investigación en Salud, Mexico

Brief 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

Condition or disease Intervention/treatment Phase
Covid19 Drug: Azithromycin / Ivermectin / Ribaroxaban / Paracetamol Drug: Azithromycin / Ribaroxaban / Paracetamol Phase 3

Detailed Description:

Coronavirus disease (COVID-19) is caused by SARS-COV2 and represents the causative agent of a potential fatal disease generating a global public health problem. Person-to-person transmission of COVID-19 infection led to the isolation of patients who subsequently received a variety of treatments. Ivermectin treatment for safety is approved for human use by the FDA in parasitic and skin infections. Studies report the therapeutic safety of Ivermectin in humans with COVID-19, describing a 6.1-fold decrease in lethality compared to patients who did not use Ivermectin (1.4 vs. 8.5%, p <0.0001). In this sense, the WHO and PAHO encourage the use of unproven therapies in the context of a randomized clinical trial (RCT). Anticoagulants have reported up to 20% in the reduction of mortality (heparin), Ribaroxaban is effective with the inhibition of PAR1 / PAR2 / PAR4 receptors through the blocking of Factor Xa and the formation of thrombin, having anti-inflammatory effects, decreasing arteriosclerosis and platelet aggregation. There is a Telemedicine working method implemented by the OOAD of the North Federal District, which detects early signs and symptoms of possible complications and offers an early intervention treatment policy for first-level care beneficiaries. Under this method, a quasi-experimental study showed that there is a modification in the frequency of recovered patients of 80-90% in patients diagnosed with COVID-19 after an early intervention treatment with paracetamol, Ivermectin, Azithromycin, Ribaroxaban in patients with COVID -19 from UMF 13 during the period of July-August 2020. Therefore, it is necessary to carry out a randomized clinical trial to confirm this assertion.

Objective: To evaluate the percentage of patients with a diagnosis of COVID-19 who modify their clinical evolution under a comparative treatment of early intervention in beneficiaries of the U.M.F 13 and U.M.F 20 of the I.M.S.S., during the period of December 2020-January 2021.

Material and Methods: A randomized, single-blind, prospective, longitudinal and open experimental study in 62 patients with COVID-19 from UMF No. 13 and No. 20 from November to December 2020. Including 31 patients in group A (Azithromycin / Ivermectin / Ribaroxaban / Paracetamol) and 31 patients in group B (Azithromycin / Ribaroxaban / Paracetamol). With inclusion criteria over 18 years of age, have type 2 diabetes mellitus, Systemic Arterial Hypertension, Obesity or overweight, PCR confirmation of COVID-19. For the video call, the Family Medicine Units have Electronic Equipment Installation for Internet use. Exclusion criteria are patients with severe COVID-19 (they deserve immediate referral to second level of care, hospital). Elimination criteria are Prior informed consent, medication is given randomly to a COVID-19 patient, a follow-up video call will be made at home for 14 days, recording sex, age, education, date of disease onset, taking laboratories (hematic biometry, C-reactive protein, D-dimer, Ferritin, prothrombin time, thromboplastin time, lactic dehydrogenase) taken at the onset of the disease, taking as an outcome variable the modification of the clinical course (clinical symptoms such as headache, cough, fever, conjunctivitis , myalgias, arthralgias, rhinorrhea, odynophagia, anosmia, chest pain, dyspnea) when granting treatment in groups A and B.. Statistical differences will be evaluated using the Mann-Whitney U test with a power of 90% and a type I error rate of 1% for the variable of modification of the clinical course in treatment groups A and B. analysis will be performed in SPSS version 21.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
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).
Primary Purpose: Treatment
Official Title: Prognostic Modification in Patients With COVID-19 Under Early Intervention Treatment at U.M.F 13 and U.M.F 20
Actual Study Start Date : December 16, 2020
Estimated Primary Completion Date : February 2, 2021
Estimated Study Completion Date : February 12, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Triple therapy
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 500 mg tablets will take 1 tablet single dose the first day and then half tablet (250 mg) orally every 24 for 4 days, Ivermectin tablets of 200mcg which will be calculated according to your weight and dose, will be every 24 hours for 2 days and Rivaroxaban tablets of 10 mg will take 1 every 24 hours for 10 days
Drug: Azithromycin / Ivermectin / Ribaroxaban / Paracetamol
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
Other Name: with Ivermectin

Active Comparator: Double therapy
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 500 mg tablets will take 1 tablet single dose the first day and then half a tablet orally every 24 for 4 days and Rivaroxaban 10 mg tablets will take 1 every 24 hours for 10 days.
Drug: Azithromycin / Ribaroxaban / Paracetamol
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
Other Name: without Ivermectin




Primary Outcome Measures :
  1. Estimate clinical symptoms by days of follow-up in patients with COVID-19 under treatment with Azithromycin/Ivermectin/Ribaroxaban/Paracetamol vs. Azithromycin/Ribaroxaban/Paracetamol followed by video call for 14 days from U.M.F 13 and U.M.F 20 [ Time Frame: 14 days ]
    Assuming 25% efficacy in modifying the clinical course (Symptoms of fever, cough, headache, myalgia, odynophagia, anosmia, rhinorrhea, arthralgia, chest pain, dyspnea, conjunctivitis) of patients diagnosed with COVID-19 under treatment comparative of early intervention for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of 20%; We calculated a total of 62 patients with COVID-19, that is, 31 cases in group A with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol treatment and 31 in group B with Azithromycin / Ribaroxaban / Paracetamol treatment would be necessary for the analysis. Statistical differences will be evaluated using the Mann-Whitney U test. The analyzes will be performed in SPSS version 21


Secondary Outcome Measures :
  1. To assess adverse drug reactions by days of follow-up in patients with COVID-19 under treatment with Azithromycin/Ivermectin/Ribaroxaban /Paracetamol vs. Azithromycin /Ribaroxaban/Paracetamol followed by video call for 14 days from U.M.F 13 and U.M.F 20 [ Time Frame: 14 days ]
    Assuming a 25% efficacy in modifying the clinical course (adverse reactions) of patients diagnosed with COVID-19 under a comparative early intervention treatment for 14 days followed by video call, with a power of 90%, an error rate type I of 1% and loss to follow-up of 20%; We calculated a total of 62 patients with COVID-19, that is, 31 cases in group A with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol treatment and 31 in group B with Azithromycin / Ribaroxaban / Paracetamol treatment would be necessary for the analysis. Statistical differences will be evaluated using the Mann-Whitney U test. The analyzes will be performed in SPSS version 21



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673214


Contacts
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Contact: GILBERTO CR ARTEAGA, specialist 55 87 44 22 ext 15320 gilberto.cruz@imss.gob.mx
Contact: ALMA ITALIA GU MARTINEZ, specialist 55 61 27 00 ext 21315 italia.guerrero@imss.gob.mx

Locations
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Mexico
Alma Italia Guerrero Martinez Recruiting
Mexico, Distrito Federal, Mexico, 02000
Contact: GILBERTO CR ARTEAGA, SPECIALIST    55 87 44 22 ext 15320    gilberto.cruz@imss.gob.mx   
Contact: ALMA ITALIA GU MARTINEZ, SPECIALIST    55 61 27 00 ext 21315    italia.guerrero@imss.gob.mx   
Sponsors and Collaborators
Gilberto Cruz Arteaga
Coordinación de Investigación en Salud, Mexico
Investigators
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Principal Investigator: GILBERTO CR ARTEAGA, specialist MEXICAN SOCIAL SECURITY INSTITUTE
Additional Information:
Publications of Results:

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Responsible Party: Gilberto Cruz Arteaga, Clinical Coordinator of Health Education and Research, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT04673214    
Other Study ID Numbers: R-2020-785-176
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: SHARED VIA EMAIL IF OTHER RESEARCHERS REQUIRE IT

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acetaminophen
Azithromycin
Ivermectin
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents