COVID-19Phase 4AICNCT04359316
Azithromycin in Hospitalized COVID-19 Patients
A Phase 4 study testing Hydroxychloroquine and Azithromycin in people with COVID-19, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. 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 and Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 20 Apr 2020to 5 May 2020
- Phase
- Phase 4
- 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
- Age ≥ 18
- COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed).
- Tympanic Temperature of ≥37.5 AND at least one of the following: Cough, Sputum production, nasal discharge, myalgia, headache or fatigue) on admission.
- Time of onset of the symptoms should be acute ( Days ≤ 10).
- SpO2 ≤ 93%
- Respiratory Rate ≥ 22
Who cannot join
- Refusal to participate expressed by patient or legally authorized representative if they are present.
- Patients with prolonged QT or PR intervals, Second or Third Degree heart block and Arrhythmias.
- Patients using drugs with potential interaction with Azithromycin or Hydroxychloroquine.
- Pregnant or lactating women.
- History of alcohol or drug addiction in the past 5 years.
- Blood ALT/AST levels > 5 times the upper limit of normal on laboratory results.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences and Health Services
Tehran
About this study
Official title: Efficacy and Safety of Azithromycin Compared to the Base Therapeutic Regiment of Hydroxychloroquine in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial
The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
Read the detailed description
Chloroquine has been a broadly-utilized anti-malaria agent which back in 2006, had been proved to be a powerful wide-spectrum antiviral. Moreover, Chloroquine has the characteristics of anti-inflammatory and immune-modulatory by inhibiting the production of TNF-α along with IL-6. In the first half of February, a study illustrated puissant inhibition of SARS-CoV-2 by Chloroquine, when taking two 500-mg tablets of it by mouth per day; similar to some clinical studies in China through this outbreak. According to the news briefing of a study, it was indicated that chloroquine phosphate actually outdo the control treatment in inhibition of pneumonia exacerbation, improving lung imaging findings, and curtailing the disease course. Another study evaluated the possible doses of CQ and HCQ to find the optimized dose in treatment of COVID-19. They revealed that while within in-vitro settings Hydroxychloroquine is more potent than chloroquine. As a conclusion, they suggested a 800 mg daily dose of hydroxychloroquine, followed by an overall maintenance dose of 400 mg per day divided in two separate doses, which was three-fold more potent compared to the 500 mg twice daily administration of chloroquine in 5 days. The new study published in 16th March, pointed out that hydroxychloroquine was notably effectual in eradicating SARS-CoV-2 from the nasopharynx. Currently the evidence is quite inconclusive about the effectiveness or comparative effectiveness of either HCQ or CQ. Moreover, CQ has recently become scarce and even unavailable for ordering due to a huge demand for it, all because of a significant interest gained as a potential medicinal alternative for the management of COVID-19. In spite of all, the primary experience in China and France is propitious for the potential role of chloroquine, or alternatively hydroxychloroquine, for managing COVID-19.
The reported clinical benefits of the combination of hydroxychloroquine and azithromycin for patients with COVID-19 come either from media reports or nonrandomized trials with small numbers of participants (<100 patients). The documented benefit of hydroxychloroquine with or without azithromycin is very limited, especially in severe disease. While these medications, individually or in combination, may prove efficacious, these benefits need to be established with randomized clinical trials prior to widespread adoption of these treatments.
The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine, Azithromycin
- Keywords
- COVID-19, SARS-CoV-2, Novel Coronavirus, Hydroxychloroquine, Chloroquine, 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.
This Drug will be used in all arms as mandated by our governmental guidelines.
AzithromycinDrug
This will be drug only used in the intervention arm of our study, designed mainly to assess the additional efficacy and safety of Azithromycin in COVID-19 patients.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Experimental | Not described Receives: Drug: Hydroxychloroquine; Drug: Azithromycin |
| Hydroxychloroquine | Active comparator | Not described Receives: Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical improvement
Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R\&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.
Measured: From date of randomization until 14 days later.
Secondary outcomes (5)
Mortality
If the patient dies, we have reached an outcome.
Measured: From date of randomization until 14 days later.
SpO2 Improvement
Pulse-oxymetry
Measured: Days 1, 2, 3, 4, 5, 6, 7 and 14.
Incidence of new mechanical ventilation use
Incidence of new mechanical ventilation use (Rate)
Measured: From date of randomization until 14 days later.
Duration of hospitalization
Duration of hospitalization (Days)
Measured: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.
Cumulative incidence of serious adverse events
With incidence of any serious adverse effects, the outcome has happened.
Measured: Days 1, 2, 3, 4, 5, 6, 7 and 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start20 Apr 2020 (estimated)
- Primary completion3 May 2020 (estimated)
- Study completion5 May 2020 (estimated)
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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study is a randomized, double-blind, placebo-controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyed Sina Naghibi Irvani, MD, MPH, MBA, Senior Researcher., Shahid Beheshti University of Medical Sciences
- Investigators
- Mohammad Fathi, MD, Study chair, Shahid Beheshti University of Medical SciencesSasan Tavana, MD, Study director, Shahid Beheshti University of Medical SciencesNasser Malekpour Alamdari, MD, Principal investigator, Shahid Beheshti University of Medical SciencesMehran Lack, MD, Principal investigator, Shahid Beheshti University of Medical SciencesNader Markazi, MD, Principal investigator, Shahid Beheshti University of Medical SciencesSanaz Zargar Balaye Jam, MD, Principal investigator, Shahid Beheshti University of Medical SciencesSeyed Sina Naghibi Irvani, MD, MPH, MBA, Principal investigator, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359316
- Sponsor's protocol ID
- Azithromycin in COVID-19
- Acronym
- AIC
- Status last verified
- Apr 2020
- First submitted
- 18 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no further information.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Azithromycin Compared to the Base Therapeutic Regiment of Hydroxychloroquine in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial
- ClinicalTrials.gov ID
- NCT04359316
- Acronym / sponsor ID
- AIC / Azithromycin in COVID-19
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, Novel Coronavirus, Hydroxychloroquine, Chloroquine, Azithromycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Apr 2020 (estimated)
- Primary completion
- 3 May 2020 (estimated)
- Study completion
- 5 May 2020 (estimated)
- First posted
- 24 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.
The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
Detailed description
Chloroquine has been a broadly-utilized anti-malaria agent which back in 2006, had been proved to be a powerful wide-spectrum antiviral. Moreover, Chloroquine has the characteristics of anti-inflammatory and immune-modulatory by inhibiting the production of TNF-α along with IL-6. In the first half of February, a study illustrated puissant inhibition of SARS-CoV-2 by Chloroquine, when taking two 500-mg tablets of it by mouth per day; similar to some clinical studies in China through this outbreak. According to the news briefing of a study, it was indicated that chloroquine phosphate actually outdo the control treatment in inhibition of pneumonia exacerbation, improving lung imaging findings, and curtailing the disease course. Another study evaluated the possible doses of CQ and HCQ to find the optimized dose in treatment of COVID-19. They revealed that while within in-vitro settings Hydroxychloroquine is more potent than chloroquine. As a conclusion, they suggested a 800 mg daily dose of hydroxychloroquine, followed by an overall maintenance dose of 400 mg per day divided in two separate doses, which was three-fold more potent compared to the 500 mg twice daily administration of chloroquine in 5 days. The new study published in 16th March, pointed out that hydroxychloroquine was notably effectual in eradicating SARS-CoV-2 from the nasopharynx. Currently the evidence is quite inconclusive about the effectiveness or comparative effectiveness of either HCQ or CQ. Moreover, CQ has recently become scarce and even unavailable for ordering due to a huge demand for it, all because of a significant interest gained as a potential medicinal alternative for the management of COVID-19. In spite of all, the primary experience in China and France is propitious for the potential role of chloroquine, or alternatively hydroxychloroquine, for managing COVID-19.
The reported clinical benefits of the combination of hydroxychloroquine and azithromycin for patients with COVID-19 come either from media reports or nonrandomized trials with small numbers of participants (<100 patients). The documented benefit of hydroxychloroquine with or without azithromycin is very limited, especially in severe disease. While these medications, individually or in combination, may prove efficacious, these benefits need to be established with randomized clinical trials prior to widespread adoption of these treatments.
The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The present study is a randomized, double-blind, placebo-controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Experimental | Drug: Hydroxychloroquine, Drug: Azithromycin |
| Hydroxychloroquine | Active comparator | Drug: Hydroxychloroquine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18
- COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed).
- Tympanic Temperature of ≥37.5 AND at least one of the following: Cough, Sputum production, nasal discharge, myalgia, headache or fatigue) on admission.
- Time of onset of the symptoms should be acute ( Days ≤ 10).
- SpO2 ≤ 93%
Key exclusion criteria (6 listed)
- Refusal to participate expressed by patient or legally authorized representative if they are present.
- Patients with prolonged QT or PR intervals, Second or Third Degree heart block and Arrhythmias.
- Patients using drugs with potential interaction with Azithromycin or Hydroxychloroquine.
- Pregnant or lactating women.
- History of alcohol or drug addiction in the past 5 years.
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 |
|---|---|---|
| HydroxychloroquineThis Drug will be used in all arms as mandated by our governmental guidelines. | Drug | Azithromycin, Hydroxychloroquine |
| AzithromycinThis will be drug only used in the intervention arm of our study, designed mainly to assess the additional efficacy and safety of Azithromycin in COVID-19 patients. | Drug | Azithromycin |
Primary outcome
Time to clinical improvement
Time frame: From date of randomization until 14 days later.
Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R\&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.
5 secondary outcomes
Mortality
Time frame: From date of randomization until 14 days later.
SpO2 Improvement
Time frame: Days 1, 2, 3, 4, 5, 6, 7 and 14.
Incidence of new mechanical ventilation use
Time frame: From date of randomization until 14 days later.
Duration of hospitalization
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.
Cumulative incidence of serious adverse events
Time frame: Days 1, 2, 3, 4, 5, 6, 7 and 14.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: Undecided. There is no further information.
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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.
Mohammad Fathi, MD study chair
Shahid Beheshti University of Medical Sciences
Sasan Tavana, MD study director
Shahid Beheshti University of Medical Sciences
Nasser Malekpour Alamdari, MD principal investigator
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxychloroquine and Azithromycin in people with COVID-19, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 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 24 Apr 2020. 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 Iran. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Seyed Sina Naghibi Irvani, MD, MPH, MBA (09141182825, sina.irvani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical improvement (time frame: From date of randomization until 14 days later.). 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 24 Apr 2020.