Covid19
Conditions
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
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.
Interventions
DRUGAzithromycin / 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
DRUGAzithromycin / 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
Sponsors
Coordinación de Investigación en Salud, Mexico
Gilberto Cruz Arteaga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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).
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | 14 days | Statistical differences were evaluated using Student's t test for quantitative variables. In relation to the presence of the number of days with clinical symptoms of COVID-19 by double therapy vs. triple therapy. |
| Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS | 14 days | Statistical differences between clinical evolution vs therapeutic failure by type of treatment were evaluated using Pearson's Chi-square test as categorical variables. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | 14 days | Statistical differences were evaluated using Student's t test for quantitative variables. The average duration of days with clinical symptoms of COVID-19 under early intervention treatment by outcome in the improvement of the modification of the clinical evolution of symptoms vs. therapeutic failure. |
| Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | 14 days | Survival analysis. The time it takes for 50% of COVID-19 patients to improve symptoms during a 14-day follow-up with dual therapy vs. triple therapy |
Countries
Mexico
Participant flow
Recruitment details
Recruitment begins on December 16, 2020 in the Family Medicine Unit No.13 and in the Family Medicine Unit No.20 of the Mexican Institute of Social Security.
Pre-assignment details
There were no excluded patients.
Participants by arm
| Arm | Count |
|---|---|
| Double Therapy The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C. | 46 |
| Triple Therapy The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Ivermectin 6 mg tablets take as follows 2 TABLETS \<80 KG orally, 3 TABLETS between 80-110 kg orally, 4 TABLETS\> 110kg orally, every 24 hours for 2 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C. | 65 |
| Total | 111 |
Baseline characteristics
| Characteristic | Double Therapy | Total | Triple Therapy |
|---|---|---|---|
| Age 21-30 years | 8 Participants | 14 Participants | 6 Participants |
| Age 31-40 years | 12 Participants | 29 Participants | 17 Participants |
| Age 41-50 years | 14 Participants | 36 Participants | 22 Participants |
| Age 51-60 years | 7 Participants | 15 Participants | 8 Participants |
| Age 61-70 years | 5 Participants | 13 Participants | 8 Participants |
| Age ≥ 71 years | 0 Participants | 4 Participants | 4 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 4 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 107 Participants | 61 Participants |
| Civil Status Divorced | 1 Participants | 3 Participants | 2 Participants |
| Civil Status Free Union | 7 Participants | 12 Participants | 5 Participants |
| Civil Status Married | 25 Participants | 69 Participants | 44 Participants |
| Civil Status Single | 12 Participants | 25 Participants | 13 Participants |
| Civil Status Widower | 1 Participants | 2 Participants | 1 Participants |
| Education Degree | 21 Participants | 53 Participants | 32 Participants |
| Education High school | 3 Participants | 12 Participants | 9 Participants |
| Education Others | 3 Participants | 13 Participants | 10 Participants |
| Education Preparatory | 13 Participants | 22 Participants | 9 Participants |
| Education Primary | 2 Participants | 3 Participants | 1 Participants |
| Education Technical career | 4 Participants | 8 Participants | 4 Participants |
| Occupation Full time | 41 Participants | 81 Participants | 40 Participants |
| Occupation Housewife | 1 Participants | 5 Participants | 4 Participants |
| Occupation Part time | 2 Participants | 13 Participants | 11 Participants |
| Occupation Pensioner | 2 Participants | 11 Participants | 9 Participants |
| Occupation Unemployed | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Mestizo Mexicans | 46 participants | 111 participants | 65 participants |
| Region of Enrollment Mexico | 46 Participants | 111 Participants | 65 Participants |
| Sex: Female, Male Female | 24 Participants | 58 Participants | 34 Participants |
| Sex: Female, Male Male | 22 Participants | 53 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 46 | 2 / 65 |
| other Total, other adverse events | 39 / 46 | 49 / 65 |
| serious Total, serious adverse events | 0 / 46 | 0 / 65 |
Outcome results
Primary
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Statistical differences were evaluated using Student's t test for quantitative variables. In relation to the presence of the number of days with clinical symptoms of COVID-19 by double therapy vs. triple therapy.
Time frame: 14 days
Population: Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%; A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Dysnea at rest | 1 days | Standard Deviation 3.3 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Myalgia | 6 days | Standard Deviation 5.6 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Cough | 7 days | Standard Deviation 5.4 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Conjunctivitis | 2 days | Standard Deviation 4.1 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Headache | 6 days | Standard Deviation 5.2 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Chest pain | 5 days | Standard Deviation 5.6 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Fever | 2 days | Standard Deviation 3.4 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Dyspnea of movement | 2 days | Standard Deviation 4.1 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Anosmia | 5 days | Standard Deviation 5.8 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Major symptoms | 5 days | Standard Deviation 3.1 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Odynophagia | 5 days | Standard Deviation 4.8 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Minor symptoms | 3 days | Standard Deviation 2.7 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Rhinorrhea | 3 days | Standard Deviation 4.8 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | treatment start day | 4 days | Standard Deviation 1.9 |
| DOUBLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Diarrhea | 2 days | Standard Deviation 4 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | treatment start day | 4 days | Standard Deviation 1.6 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Headache | 5 days | Standard Deviation 4.9 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Myalgia | 5 days | Standard Deviation 5 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Dyspnea of movement | 2 days | Standard Deviation 3.9 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Cough | 7 days | Standard Deviation 5.6 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Rhinorrhea | 3 days | Standard Deviation 4.3 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Odynophagia | 5 days | Standard Deviation 5.4 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Diarrhea | 1 days | Standard Deviation 2.2 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Anosmia | 6 days | Standard Deviation 5.9 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Conjunctivitis | 1 days | Standard Deviation 2.9 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Chest pain | 4 days | Standard Deviation 4.8 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Dysnea at rest | 2 days | Standard Deviation 3.6 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Major symptoms | 5 days | Standard Deviation 3.4 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Minor symptoms | 3 days | Standard Deviation 2.5 |
| TRIPLE THERAPY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | Fever | 2 days | Standard Deviation 3.2 |
Comparison: Null Hypothesis: There will be no modification in the clinical evolution ≥ 25% of patients diagnosed with COVID-19 under an early intervention treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol for 14 days followed by video call from U.M.F 13 and U.M.F 20 from I.M.S.S., during the period of December 2020- February 2021, with a power of 90%, type I error rate 1% and loss to follow-up 20%.p-value: 0.05Chi-squared
Comparison: Assuming a difference of 2 days in the modification of the clinical course (symptoms of fever, cough, headache, myalgia, odynophagia, anosmia, rhinorrhea, arthralgia, chest pain, dyspnea, conjunctivitis) of patients diagnosed with COVID-19 in early intervention treatment vs. therapeutic failure, 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 the twenty%p-value: 0.05t-test, 2 sided
Primary
Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS
Statistical differences between clinical evolution vs therapeutic failure by type of treatment were evaluated using Pearson's Chi-square test as categorical variables.
Time frame: 14 days
Population: Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%; A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DOUBLE THERAPY | Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS | Number of Participants with Improvement in Clinical Evaluation | 44 Participants |
| DOUBLE THERAPY | Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS | Number of Participants with Therapeutic Failure | 2 Participants |
| TRIPLE THERAPY | Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS | Number of Participants with Improvement in Clinical Evaluation | 59 Participants |
| TRIPLE THERAPY | Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS | Number of Participants with Therapeutic Failure | 6 Participants |
Comparison: Assuming a difference in the percentage of effectiveness in the clinical modification and therapeutic failure of patients diagnosed with COVID-19 under treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed 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%p-value: 0.05Chi-squared
Other Pre-specified
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Statistical differences were evaluated using Student's t test for quantitative variables. The average duration of days with clinical symptoms of COVID-19 under early intervention treatment by outcome in the improvement of the modification of the clinical evolution of symptoms vs. therapeutic failure.
Time frame: 14 days
Population: Assuming a difference in days of effectiveness in clinical modification and therapeutic failure of patients diagnosed with COVID-19 in treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a potency 90%, a Type I error rate of 1%, and a loss to follow-up of 20%
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Fever | 2 Days | Standard Deviation 3.3 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Diarrhea | 2 Days | Standard Deviation 3.2 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Dyspnea of movement | 2 Days | Standard Deviation 4.1 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Cough | 7 Days | Standard Deviation 5.6 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Headache | 6 Days | Standard Deviation 5 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Rhinorrhea | 4 Days | Standard Deviation 4.6 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Odynophagia | 5 Days | Standard Deviation 5.2 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Myalgia | 6 Days | Standard Deviation 5.4 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Anosmia | 6 Days | Standard Deviation 6 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Conjunctivitis | 1 Days | Standard Deviation 3.6 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Chest Pain | 4 Days | Standard Deviation 5.2 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Dyspnea at Rest | 1 Days | Standard Deviation 3.5 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Major Symptoms | 5 Days | Standard Deviation 3.3 |
| DOUBLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Minor Symptoms | 3 Days | Standard Deviation 2.6 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Chest Pain | 1 Days | Standard Deviation 1.5 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Fever | 1 Days | Standard Deviation 1.7 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Myalgia | 5 Days | Standard Deviation 2 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Diarrhea | 1 Days | Standard Deviation 2.1 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Major Symptoms | 2 Days | Standard Deviation 1.5 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Dyspnea of movement | 3 Days | Standard Deviation 2.9 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Anosmia | 2 Days | Standard Deviation 2.3 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Cough | 4 Days | Standard Deviation 3.3 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Dyspnea at Rest | 3 Days | Standard Deviation 2.9 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Headache | 2 Days | Standard Deviation 2 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Conjunctivitis | 1 Days | Standard Deviation 1.4 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Rhinorrhea | 1 Days | Standard Deviation 1.4 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Minor Symptoms | 2 Days | Standard Deviation 1.2 |
| TRIPLE THERAPY | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | Odynophagia | 2 Days | Standard Deviation 3.2 |
Comparison: Assuming a difference in days of effectiveness in clinical modification and therapeutic failure of patients diagnosed with COVID-19 in treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a potency 90%, a Type I error rate of 1%, and a loss to follow-up of 20%p-value: 0.05t-test, 2 sided
Other Pre-specified
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Survival analysis. The time it takes for 50% of COVID-19 patients to improve symptoms during a 14-day follow-up with dual therapy vs. triple therapy
Time frame: 14 days
Population: Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%; A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DOUBLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Chest pain | 25 Participants |
| DOUBLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Rhinorrhea | 17 Participants |
| DOUBLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Dyspnea of movement | 14 Participants |
| DOUBLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Dyspnea at rest | 9 Participants |
| DOUBLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Cought | 16 Participants |
| DOUBLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Fever | 10 Participants |
| DOUBLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Headache | 6 Participants |
| DOUBLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Anosmia | 34 Participants |
| DOUBLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Conjunctivitis | 13 Participants |
| DOUBLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Diarrhea | 8 Participants |
| DOUBLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Myalgia | 23 Participants |
| DOUBLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Odynophagia | 26 Participants |
| TRIPLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Conjunctivitis | 8 Participants |
| TRIPLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Odynophagia | 35 Participants |
| TRIPLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Headache | 7 Participants |
| TRIPLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Chest pain | 33 Participants |
| TRIPLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Rhinorrhea | 16 Participants |
| TRIPLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Dyspnea of movement | 18 Participants |
| TRIPLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Myalgia | 35 Participants |
| TRIPLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Dyspnea at rest | 16 Participants |
| TRIPLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Anosmia | 33 Participants |
| TRIPLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Cought | 26 Participants |
| TRIPLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Diarrhea | 11 Participants |
| TRIPLE THERAPY | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | Fever | 7 Participants |
Comparison: Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%p-value: 0.05Wilcoxon (Gehan) statistical test