Covid19Phase 2/3OmehecatlNCT04964583
Hidroxicloroquina With Azitromicina Versus Hidroxicloroquina and Placebo Int Patients With Mild COVID-19
A Phase 2/3 study testing Hydroxychloroquine with Azithromycin in people with Covid19, run by Coordinación de Investigación en Salud, Mexico at 3 sites in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19
- What is being tested?
- Hydroxychloroquine with Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 3 sitesMexico
- Study dates
- 20 Jan 2021to Aug 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites, 3 recruiting
- Recruiting
UMF 28
Benito Juárez, Mexico City, 03100
Ivonne A Roy, MD, 525522704760, ivonne3316@gmail.com
Magaly A Ortiz Zamora, MD
- Not yet recruiting
Fundación IMSS
Cuauhtémoc, Mexico City, 06600
Martha M Zapata Tarrés, MD, 5554184099
Marta M Zapata Tarrés, MD
- Recruiting
UMF 52
Cuautitlán Izcalli, State of Mexico, 54720
Moises Moreno, MD, 5565593877, sesby14@gmail.com
Miroslava Guzmán Rivas, MD
About this study
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
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.
Read more
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.
- Conditions
- Covid19
- Being tested
- Hydroxychloroquine with Azithromycin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine with AzithromycinDrug
Also called Azithromycin
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.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine with Azithromycin | Experimental | 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. Receives: Drug: Hydroxychloroquine with Azithromycin |
| Hydroxychloroquine | Active comparator | Hydroxychloroquine 200 mg, one tablet every 12 hours for ten days. Receives: Drug: Hydroxychloroquine with Azithromycin |
| Placebo | Placebo comparator | Placebo one tablet every 12 hours for ten days. Receives: Drug: Hydroxychloroquine with Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization
Being admitted for hospitalization
Measured: 15 days
Secondary outcomes (2)
Viral load
Measured by RT-PCR
Measured: 0 and 14 days
Clinical safety
any adverse event
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start20 Jan 2021
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Ultra Laboratorios SA. de CV.
- Responsible party
- Principal investigator, Rodolfo Rivas Ruiz, Coordinación de Investigación en Salud, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964583
- Sponsor's protocol ID
- 2020-785-138
- Acronym
- Omehecatl
- Status last verified
- Aug 2021
- First submitted
- 25 Jun 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Database with all non identifiable data will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04964583
- Acronym / sponsor ID
- Omehecatl / 2020-785-138
- Conditions
- Covid19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Ultra Laboratorios SA. de CV.
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine with Azithromycin | Experimental | Drug: Hydroxychloroquine with AzithromycinFixed 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 | Active comparator | Drug: Hydroxychloroquine with AzithromycinHydroxychloroquine 200 mg, one tablet every 12 hours for ten days. |
| Placebo | Placebo comparator | Drug: Hydroxychloroquine with AzithromycinPlacebo one tablet every 12 hours for ten days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine with AzithromycinAlso: AzithromycinFixed 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. | Drug | Hydroxychloroquine, Hydroxychloroquine with Azithromycin, Placebo |
Primary outcome
Hospitalization
Time frame: 15 days
Being admitted for hospitalization
2 secondary outcomes
Viral load
Time frame: 0 and 14 days
Clinical safety
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: Yes. Database with all non identifiable data will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hydroxychloroquine with Azithromycin in people with Covid19, run by Coordinación de Investigación en Salud, Mexico at 3 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.