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

NCT04673214 | Completed Phase 3 Results DMC

• 1 other identifier: R-2020-785-176
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• 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.

  14 days

• 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.

  14 days

Other Outcomes (2)

• Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS

  14 days

• Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up

  14 days

Study Arms (2)

Triple therapy

EXPERIMENTAL

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

Double therapy

ACTIVE COMPARATOR

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

Interventions

Azithromycin / Ivermectin / Ribaroxaban / Paracetamol DRUG

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

Also known as: with Ivermectin

Triple therapy

Azithromycin / Ribaroxaban / Paracetamol DRUG

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

Also known as: without Ivermectin

Double therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilberto Cruz Arteaga: lead
• Coordinación de Investigación en Salud, Mexico: collaborator

Study Sites (1)

Alma Italia Guerrero Martinez

Mexico City, Mexico City, 02000, Mexico

Location

Related Publications (6)

• Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.

  PMID: 32205204 BACKGROUND

• Becattini C, Pace U, Rondelli F, Delrio P, Ceccarelli G, Boncompagni M, Graziosi L, Visona A, Chiari D, Avruscio G, Frasson S, Gussoni G, Biancafarina A, Camporese G, Donini A, Bucci AF, Agnelli G. Rivaroxaban for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer. Design of the PRO-LAPS II STUDY. Eur J Intern Med. 2020 Feb;72:53-59. doi: 10.1016/j.ejim.2019.11.015. Epub 2019 Dec 7.

  PMID: 31818628 BACKGROUND

• Khorana AA, Soff GA, Kakkar AK, Vadhan-Raj S, Riess H, Wun T, Streiff MB, Garcia DA, Liebman HA, Belani CP, O'Reilly EM, Patel JN, Yimer HA, Wildgoose P, Burton P, Vijapurkar U, Kaul S, Eikelboom J, McBane R, Bauer KA, Kuderer NM, Lyman GH; CASSINI Investigators. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. doi: 10.1056/NEJMoa1814630.

  PMID: 30786186 BACKGROUND

• Dugina TN, Kiseleva EV, Chistov IV, Umarova BA, Strukova SM. Receptors of the PAR family as a link between blood coagulation and inflammation. Biochemistry (Mosc). 2002 Jan;67(1):65-74. doi: 10.1023/a:1013952114485.

  PMID: 11841341 BACKGROUND

• Choudhary R, Sharma AK. Potential use of hydroxychloroquine, ivermectin and azithromycin drugs in fighting COVID-19: trends, scope and relevance. New Microbes New Infect. 2020 Apr 22;35:100684. doi: 10.1016/j.nmni.2020.100684. eCollection 2020 May.

  PMID: 32322397 BACKGROUND

• Arshad U, Pertinez H, Box H, Tatham L, Rajoli RKR, Curley P, Neary M, Sharp J, Liptrott NJ, Valentijn A, David C, Rannard SP, O'Neill PM, Aljayyoussi G, Pennington SH, Ward SA, Hill A, Back DJ, Khoo SH, Bray PG, Biagini GA, Owen A. Prioritization of Anti-SARS-Cov-2 Drug Repurposing Opportunities Based on Plasma and Target Site Concentrations Derived from their Established Human Pharmacokinetics. Clin Pharmacol Ther. 2020 Oct;108(4):775-790. doi: 10.1002/cpt.1909. Epub 2020 Jun 14.

  PMID: 32438446 BACKGROUND

Related Links

• Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial
• Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management

MeSH Terms

Conditions

COVID-19

Interventions

Azithromycin; Ivermectin; Acetaminophen

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. GILBERTO CRUZ ARTEAGA
• Organization: MEXICAN SOCIAL SECURITY INSTITUTE

gilberto.cruz@imss.gob.mx

55 87 44 22

Study Officials

• GILBERTO CR ARTEAGA, specialist

  MEXICAN SOCIAL SECURITY INSTITUTE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Coordinator of Health Education and Research

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 17, 2020
• Study Start: December 16, 2020
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: August 16, 2021
• Results First Posted: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)