Hidroxicloroquina With Azitromicina Versus Hidroxicloroquina and Placebo Int Patients With Mild COVID-19 (Omehecatl)
Primary Purpose
Covid19
Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Hydroxychloroquine with Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Have given the signed informed consent form.
- Confirmed diagnosis of COVID-19 infection by PCR with mild symptoms.
- Patients who attend the primary care respiratory care module in the participating units and who have symptoms suggestive of COVID-19, who comply with the current operational definition.
- With or without comorbidities such as hypertension, controlled diabetes mellitus, cardiovascular or respiratory diseases.
- Controlled diabetes will be considered to be that which is evidenced by results of glycosylated hemoglobin less than 7% in the last 3 tables, whether it is reported in your beneficiary file or by external laboratory results.
- Electrocardiogram (ECG) normal or with variations without clinical relevance, with QT interval <450 ms.
- No contraindication to study drugs (history of hypersensitivity to study drugs, including macrolides, patients with renal failure (eGFR <40 mL / min) or on renal replacement therapy, patients with a history of retinopathy or macular degeneration.
Exclusion Criteria:
- Patients who are participating in studies with investigational drugs.
- Pregnancy or breastfeeding.
- Type 1 diabetes
- % Type II diabetes mellitus with glycated hemoglobin greater than 7%.
- Patients requiring hospitalization or assisted mechanical ventilation
- Cardiac disorders with cardiac conduction delay (QT segment ≥ 450 ms
Sites / Locations
- UMF 28Recruiting
- Fundación IMSS
- UMF 52Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Hydroxychloroquine with Azithromycin
Hydroxychloroquine
Placebo
Arm Description
Fixed combination of Hydroxychloroquine with Azithromycin 200 mg / 250 mg one tablet every 12 hours for five days and continue with Hydroxychloroquine 200 mg one tablet every 12 hours for 5 more days.
Hydroxychloroquine 200 mg, one tablet every 12 hours for ten days.
Placebo one tablet every 12 hours for ten days.
Outcomes
Primary Outcome Measures
Hospitalization
Being admitted for hospitalization
Secondary Outcome Measures
Viral load
Measured by RT-PCR
Clinical safety
any adverse event
Full Information
NCT ID
NCT04964583
First Posted
June 25, 2021
Last Updated
August 3, 2021
Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Ultra Laboratorios SA. de CV.
1. Study Identification
Unique Protocol Identification Number
NCT04964583
Brief Title
Hidroxicloroquina With Azitromicina Versus Hidroxicloroquina and Placebo Int Patients With Mild COVID-19
Acronym
Omehecatl
Official Title
Double-blind, Randomized, Prospective, Parallel Study to Demonstrate the Efficacy and Safety of Outpatient Treatment of the Fixed Combination of Hydroxychloroquine With Azithromycin Versus Hydroxychloroquine Treatment and Placebo Treatment in Patients Diagnosed With Mild COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Ultra Laboratorios SA. de CV.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chloroquine and hydroxychloroquine are two antimalarial drugs that are also used in autoimmune diseases. Chloroquine analogs have been shown to inhibit endosome acidification and exhibit nonspecific antiviral activity at high micromolar concentration in vitro against a wide range of emerging viruses (HIV, dengue, hepatitis C, chikungunya, influenza, Ebola, SARS, and MERS ). virus) and more recently COVID-19. On the other hand, azithromycin is a macrolide antibiotic indicated for infections caused by sensitive pathogens, but which in combination with Hydroxychloroquine has shown a synergistic effect against the SARS-CoV-2 virus.
International studies show the lack of beneficial effect in hospitalized or mechanically ventilated patients. Referring that because these medications reduce the in case of having a beneficial effect it would be in the early onset, to avoid inflammation (cytokine storm), and thus prevent hospitalizations.
The present study focuses on characterizing the possible synergy of the fixed combination of hydroxychloroquine associated with azithromycin in the treatment of Covid-19 from mild to moderate manifestations. Three treatment schemes are proposed with a 10-day follow-up, a) the fixed combination of Hydroxychloroquine / Azithromycin (combination of interest), b) Hydroxychloroquine (active comparison group) and c) non-active control group, using placebo. A group of patients between 18 and 75 years old is considered, who may or may not present other comorbidities. Follow-up will be carried out through quantification of viral load, evaluation of the systemic inflammatory state, changes in clinical manifestations and possible effect on the reduction of hospitalizations. Therefore, it is proposed to carry out the following project.
objective To determine the efficacy and safety of Hydroxychloroquine / Azithromycin fixed combination compared to Hydroxychloroquine or placebo in outpatients with Research design: Phase II, multicenter, prospective, randomized, parallel, longitudinal, double-blind study.
Medications to use Group 1. Fixed combination of Hydroxychloroquine with Azithromycin 200 mg / 250 mg one tablet every 12 hours for five days and continue with Hydroxychloroquine 200 mg one tablet every 12 hours for 5 more days.
Group 2. Hydroxychloroquine 200 mg, one tablet every 12 hours for ten days. Group 3. Placebo one tablet every 12 hours for ten days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydroxychloroquine with Azithromycin
Arm Type
Experimental
Arm Description
Fixed combination of Hydroxychloroquine with Azithromycin 200 mg / 250 mg one tablet every 12 hours for five days and continue with Hydroxychloroquine 200 mg one tablet every 12 hours for 5 more days.
Arm Title
Hydroxychloroquine
Arm Type
Active Comparator
Arm Description
Hydroxychloroquine 200 mg, one tablet every 12 hours for ten days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo one tablet every 12 hours for ten days.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine with Azithromycin
Other Intervention Name(s)
Azithromycin
Intervention Description
Fixed combination of Hydroxychloroquine with Azithromycin 200 mg / 250 mg one tablet every 12 hours for five days and continue with Hydroxychloroquine 200 mg one tablet every 12 hours for 5 more days.
Primary Outcome Measure Information:
Title
Hospitalization
Description
Being admitted for hospitalization
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Viral load
Description
Measured by RT-PCR
Time Frame
0 and 14 days
Title
Clinical safety
Description
any adverse event
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have given the signed informed consent form.
Confirmed diagnosis of COVID-19 infection by PCR with mild symptoms.
Patients who attend the primary care respiratory care module in the participating units and who have symptoms suggestive of COVID-19, who comply with the current operational definition.
With or without comorbidities such as hypertension, controlled diabetes mellitus, cardiovascular or respiratory diseases.
Controlled diabetes will be considered to be that which is evidenced by results of glycosylated hemoglobin less than 7% in the last 3 tables, whether it is reported in your beneficiary file or by external laboratory results.
Electrocardiogram (ECG) normal or with variations without clinical relevance, with QT interval <450 ms.
No contraindication to study drugs (history of hypersensitivity to study drugs, including macrolides, patients with renal failure (eGFR <40 mL / min) or on renal replacement therapy, patients with a history of retinopathy or macular degeneration.
Exclusion Criteria:
Patients who are participating in studies with investigational drugs.
Pregnancy or breastfeeding.
Type 1 diabetes
% Type II diabetes mellitus with glycated hemoglobin greater than 7%.
Patients requiring hospitalization or assisted mechanical ventilation
Cardiac disorders with cardiac conduction delay (QT segment ≥ 450 ms
Facility Information:
Facility Name
UMF 28
City
Benito Juárez
State/Province
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivonne A Roy, MD
Phone
525522704760
Email
ivonne3316@gmail.com
First Name & Middle Initial & Last Name & Degree
Magaly A Ortiz Zamora, MD
First Name & Middle Initial & Last Name & Degree
Lourdes G Navarro Susano, MD
First Name & Middle Initial & Last Name & Degree
Ivonne A Roy García, MD
Facility Name
Fundación IMSS
City
Cuauhtémoc
State/Province
Mexico City
ZIP/Postal Code
06600
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha M Zapata Tarrés, MD
Phone
5554184099
First Name & Middle Initial & Last Name & Degree
Marta M Zapata Tarrés, MD
First Name & Middle Initial & Last Name & Degree
Pedro Gutierrez Castrellón, MD
First Name & Middle Initial & Last Name & Degree
Romeo Rodríguez Suárez, MD
Facility Name
UMF 52
City
Cuautitlán Izcalli
State/Province
State Of Mexico
ZIP/Postal Code
54720
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moises Moreno, MD
Phone
5565593877
Email
sesby14@gmail.com
First Name & Middle Initial & Last Name & Degree
Miroslava Guzmán Rivas, MD
First Name & Middle Initial & Last Name & Degree
Moises Moreno Noguez, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Database with all non identifiable data will be available upon request.
IPD Sharing Time Frame
6 months
Learn more about this trial
Hidroxicloroquina With Azitromicina Versus Hidroxicloroquina and Placebo Int Patients With Mild COVID-19
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