Phase 3
N=114
Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04673214 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. — 7; 7; 2; 2 days — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Azithromycin / Ivermectin / Ribaroxaban / Paracetamol (Drug); Azithromycin / Ribaroxaban / Paracetamol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilberto Cruz Arteaga
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. |
7; 7; 2; 2; 6; 5 | 0.05 |
| 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 |
44; 59; 2; 6 | 0.05 |
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.
Data sourced from ClinicalTrials.gov (NCT04673214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.