Acute Respiratory Distress SyndromePhase 2AMBUCOVNCT04954040
Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19
A Phase 2 study testing Hydroxychloroquine Pill + Azithromycin Pill and SOC in people with Acute Respiratory Distress Syndrome and Covid19, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Multi-centered, randomized, open label clinical trial to study the safety and effectivity of hydroxychloroquine + azithromycin to treat COVID-19 symptoms in primary care patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Covid19
- What is being tested?
- Hydroxychloroquine Pill + Azithromycin Pill and SOC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2021to Dec 2021
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with positive semi-quantitative PCR and COVID19 symptoms (fever, cough, diarrhea, dyspnoea, loss of smell).
- Signed informed consent
Who cannot join
- Retinal degeneration.
- Congenital or acquired long QT syndrome.
- Advanced liver failure.
- Renal insufficiency (incompatible with creatinine clearance less than 50 mL /minute).
- Allergic to hydroxychloroquine or azithromycin.
- Serious interaction with the drugs used.
Show all 9Show fewer
- Pregnant or breastfeeding.
- Men and women in fertile and sexually active periods, who do not accept a highly effective contraceptive method.
- Inability to follow study procedures.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Centro de Salud Priego de Córdoba
Priego de Córdoba, Córdoba, 14800
Jesús Gallardo de Ávila, Doctor
About this study
Official title: Clinical Trial for the Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19
Multi-centered, randomized, open label clinical trial to study the safety and effectivity of hydroxychloroquine + azithromycin to treat COVID-19 symptoms in primary care patients.
Read the detailed description
In the patient group treated with hydroxychloroquine + azithromycin we expect to find a diminution of 20% or more regarding the evolution of acute respiratory syndrome, as opposed to patients who have not been treated with these medicines.
To date, there is no shown effective treatment regime for acute respiratory distress caused by COVID-19.
- Conditions
- Acute Respiratory Distress Syndrome, Covid19
- Being tested
- Hydroxychloroquine Pill + Azithromycin Pill, SOC
- Keywords
- acute respiratory syndrome, SARS-CoV-2, COVID19, hydroxychloroquine, azithromycin, COVID19 symptoms
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Pill + Azithromycin PillDrug
Hydroxychloroquine. 1st day 200mg 2-0-2; 2nd to 5th day 200mg 1-0-1 Azithromycin.
1st day 500m 0-1-0, 2nd to 5th day 250mg 0-1-0
SOCDrug
Acetaminophen or Metamizole. Antitussives if needed.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine + Azithromycin | Experimental | Hydroxychloroquine. 1st day 200mg 2-0-2; 2nd to 5th day 200mg 1-0-1 Azithromycin. 1st day 500m 0-1-0, 2nd to 5th day 250mg 0-1-0
Oral intake in all cases. Pills will be taken simultaneously. Receives: Drug: Hydroxychloroquine Pill + Azithromycin Pill |
| SOC (Standard of Care) | Active comparator | SOC for symptoms treatment
Acetaminophen or Metamizole, 1-1-1 Antitussives if needed Receives: Drug: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization
Measured: From randomization until patient's hospitalization happens, assessed up to 28 days.
ICU admission
Measured: From date of randomization until ICU admission as a result of COVID19, assessed up to 28 days.
Death
Measured: From randomization until death by any cause related to COVID19, assessed up to 28 days.
Secondary outcomes (1)
Clinical Evolution
Clinical evolution will be evaluated through the following symptoms: fever, cough, dyspnoea, diarrhea, loss of smell.
Measured: From randomization until healing, hospitalization or death. Symptoms will be evaluated every 24 hours for a minimum of 10 days and a maximum 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start10 Feb 2021
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954040
- Sponsor's protocol ID
- AMBUCOV
- Acronym
- AMBUCOV
- Status last verified
- Apr 2021
- First submitted
- 6 Jul 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after the study concludes and results are published
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19
- ClinicalTrials.gov ID
- NCT04954040
- Acronym / sponsor ID
- AMBUCOV / AMBUCOV
- Conditions
- Acute Respiratory Distress Syndrome, Covid19
- Keywords
- acute respiratory syndrome, SARS-CoV-2, COVID19, hydroxychloroquine, azithromycin, COVID19 symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 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.
Multi-centered, randomized, open label clinical trial to study the safety and effectivity of hydroxychloroquine + azithromycin to treat COVID-19 symptoms in primary care patients.
Detailed description
In the patient group treated with hydroxychloroquine + azithromycin we expect to find a diminution of 20% or more regarding the evolution of acute respiratory syndrome, as opposed to patients who have not been treated with these medicines.
To date, there is no shown effective treatment regime for acute respiratory distress caused by COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine + Azithromycin | Experimental | Drug: Hydroxychloroquine Pill + Azithromycin PillHydroxychloroquine. 1st day 200mg 2-0-2; 2nd to 5th day 200mg 1-0-1 Azithromycin. 1st day 500m 0-1-0, 2nd to 5th day 250mg 0-1-0 Oral intake in all cases. Pills will be taken simultaneously. |
| SOC (Standard of Care) | Active comparator | Drug: SOCSOC for symptoms treatment Acetaminophen or Metamizole, 1-1-1 Antitussives if needed |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with positive semi-quantitative PCR and COVID19 symptoms (fever, cough, diarrhea, dyspnoea, loss of smell).
- Signed informed consent
Key exclusion criteria (9 listed)
- Retinal degeneration.
- Congenital or acquired long QT syndrome.
- Advanced liver failure.
- Renal insufficiency (incompatible with creatinine clearance less than 50 mL /minute).
- Allergic to hydroxychloroquine or azithromycin.
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 Pill + Azithromycin PillHydroxychloroquine. 1st day 200mg 2-0-2; 2nd to 5th day 200mg 1-0-1 Azithromycin. 1st day 500m 0-1-0, 2nd to 5th day 250mg 0-1-0 | Drug | Hydroxychloroquine + Azithromycin |
| SOCAcetaminophen or Metamizole. Antitussives if needed. | Drug | SOC (Standard of Care) |
Primary outcome
Hospitalization
Time frame: From randomization until patient's hospitalization happens, assessed up to 28 days.
ICU admission
Time frame: From date of randomization until ICU admission as a result of COVID19, assessed up to 28 days.
Death
Time frame: From randomization until death by any cause related to COVID19, assessed up to 28 days.
1 secondary outcome
Clinical Evolution
Time frame: From randomization until healing, hospitalization or death. Symptoms will be evaluated every 24 hours for a minimum of 10 days and a maximum 28 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: Yes. Data will be shared after the study concludes and results are published
Related trials for Acute Respiratory Distress Syndrome
Recruiting
NAVA Use in Preterm Neonates With Respiratory Distress Syndrome
Preterm , Respiratory Distress Syndrome, Preterm Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine Pill + Azithromycin Pill and SOC in people with Acute Respiratory Distress Syndrome and Covid19, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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 2 inclusion and 9 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 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Contact Antonio Miguel Luque Pineda (+34 671 596 070, uicec@imibic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization (time frame: From randomization until patient's hospitalization happens, assessed up to 28 days.). The study lists 3 primary outcomes in all. 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 8 Jul 2021.