COVID-19Early Phase 1NCT04329572
Efficacy and Safety of Hydroxychloroquine and Azithromycin for Patients With Moderate to Severe COVID-19
A Early Phase 1 study testing Hydroxychloroquine Sulfate and Azithromycin Tablets in people with COVID-19, run by Azidus Brasil at 1 site in Brazil.
Trial summary
This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D5) and azithromycin (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine Sulfate and Azithromycin Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Apr 2020to 30 Jun 2023
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent from patient or legal representative.
- Male or female, aged ≥ 18 years;
- Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
- At least one of the characteristic symptoms of COVID-19
- Hospitalized for up to 36h with non-invasive ventilation or up to 24h with invasive ventilation.
- Negative result for pregnancy test (if applicable).
Who cannot join
- Participating in another RCT in the past 12 months;
- Known allergy to HCQ or chloroquine
- Any contraindication to HTC or AZT, including retinopathy and prolonged QT,
- Severely reduced LV function
- Severely reduced renal function;
- Pregnancy or breast feeding
- Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus
This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D5) and azithromycin (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia.
Read the detailed description
This is an exploratory, open label, multi-center study to evaluate the efficacy of hydroxychloroquine (HCQ) (400 mg BID on D1 and 400 mg/day on D2 to D5) and azithromycin (AZT) (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia.
We aim to demonstrate decrease in hospital related complications among patients who are hospitalized with moderate or severe COVID-19 by treating them with HCQ and AZT on top of standard care compared to patients who receive standard care only.
Patients hospitalized with confirmed diagnosis of COVID-19 will receive the treatment.
Patients that do not fulfill the inclusion/exclusion criteria or that is not willing to participate in the study will be invited to consent the use of their data as part of a "control" group.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine Sulfate, Azithromycin Tablets
- 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 SulfateDrug
Also called Reuquinol
All patients included in the study will receive HCQ (400 mg BID on D1 and 400 mg/day on D2 to D5) for 5 days.
Azithromycin TabletsDrug
Also called Azithromycin
All patients included in the study will receive AZT 500 mg per day for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| HCQ + AZT | Experimental | All patients included in the study will receive HCQ (400 mg BID on D1 and 400 mg/day on D2 to D5) and AZT (500 mg/ 5 days) on top of standard care. Receives: Drug: Hydroxychloroquine Sulfate; Drug: Azithromycin Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability
Evaluation of change from baseline. Kaplan-meier method will be used.
Measured: 28 days
Secondary outcomes (5)
Viral load
Evaluation of change in viral load
Measured: Day 6
Change in Clinical Condition
Time for normalization of body temperature, respiratory rate and cough relief
Measured: 28 days
Evolution of Acute Respiratory Syndrome
Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;
Measured: 28 days
Hospital discharge
Time to be discharged from hospital
Measured: 28 days
Rate of mortality within 28-days
Evaluation of change in acute respiratory syndrome
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start23 Apr 2020
- Primary completion31 May 2020
- Study completion30 Jun 2023 (estimated)
Why it stopped: Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients included in the study will receive hydroxychloroquine (HCQ) 400 mg (BID/ 7 days) and azithromycin (AZT) (500 mg/ 5 days) on top of standard care. Patients that do not consent to participate or that do not fulfill eligibility criteria will be invited to participate as control group and will receive standard care only.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luciana Ferrara, Study director, Azidus Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329572
- Sponsor's protocol ID
- HIAPRE0320OR
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2020
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus
- ClinicalTrials.gov ID
- NCT04329572
- Acronym / sponsor ID
- HIAPRE0320OR
- Conditions
- COVID-19
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 1 Apr 2020 (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.
This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D5) and azithromycin (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia.
Detailed description
This is an exploratory, open label, multi-center study to evaluate the efficacy of hydroxychloroquine (HCQ) (400 mg BID on D1 and 400 mg/day on D2 to D5) and azithromycin (AZT) (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia.
We aim to demonstrate decrease in hospital related complications among patients who are hospitalized with moderate or severe COVID-19 by treating them with HCQ and AZT on top of standard care compared to patients who receive standard care only.
Patients hospitalized with confirmed diagnosis of COVID-19 will receive the treatment.
Patients that do not fulfill the inclusion/exclusion criteria or that is not willing to participate in the study will be invited to consent the use of their data as part of a "control" group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients included in the study will receive hydroxychloroquine (HCQ) 400 mg (BID/ 7 days) and azithromycin (AZT) (500 mg/ 5 days) on top of standard care. Patients that do not consent to participate or that do not fulfill eligibility criteria will be invited to participate as control group and will receive standard care only.
| Arm | Type | Receives |
|---|---|---|
| HCQ + AZT | Experimental | Drug: Hydroxychloroquine Sulfate, Drug: Azithromycin TabletsAll patients included in the study will receive HCQ (400 mg BID on D1 and 400 mg/day on D2 to D5) and AZT (500 mg/ 5 days) on top of standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent from patient or legal representative.
- Male or female, aged ≥ 18 years;
- Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
- At least one of the characteristic symptoms of COVID-19
- Hospitalized for up to 36h with non-invasive ventilation or up to 24h with invasive ventilation.
Key exclusion criteria (7 listed)
- Participating in another RCT in the past 12 months;
- Known allergy to HCQ or chloroquine
- Any contraindication to HTC or AZT, including retinopathy and prolonged QT,
- Severely reduced LV function
- Severely reduced renal function;
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 SulfateAlso: ReuquinolAll patients included in the study will receive HCQ (400 mg BID on D1 and 400 mg/day on D2 to D5) for 5 days. | Drug | HCQ + AZT |
| Azithromycin TabletsAlso: AzithromycinAll patients included in the study will receive AZT 500 mg per day for 5 days. | Drug | HCQ + AZT |
Primary outcome
Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability
Time frame: 28 days
Evaluation of change from baseline. Kaplan-meier method will be used.
5 secondary outcomes
Viral load
Time frame: Day 6
Change in Clinical Condition
Time frame: 28 days
Evolution of Acute Respiratory Syndrome
Time frame: 28 days
Hospital discharge
Time frame: 28 days
Rate of mortality within 28-days
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No. It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
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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.
Luciana Ferrara study director
Azidus Brasil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hydroxychloroquine Sulfate and Azithromycin Tablets in people with COVID-19, run by Azidus Brasil at 1 site in Brazil.
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 6 inclusion and 7 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: paused, as of the sponsor's last update on 7 Nov 2022. 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 Brazil. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability (time frame: 28 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 7 Nov 2022.