COVID-19Phase 2ACHIEVENCT04398004
Anti-inflammatory Clarithromycin for Improving COVID-19 Infection Early
A Phase 2 study testing Clarithromycin in people with COVID-19 and Virus Diseases, run by Hellenic Institute for the Study of Sepsis at 9 sites in Greece.
Trial summary
Recent information appearing from different countries suggest that treatment of Coronavirus disease 2019 (COVID-19) with hydroxychloroquine or with a combination of hydroxychloroquine and azithromycin has either an indifferent effect on viral replication or substantial cardiotoxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Virus Diseases, Corona Virus Infection
- What is being tested?
- Clarithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 9 sitesGreece
- Study dates
- 6 May 2020to 30 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Male of female gender
- Written informed consent provided by the patients or by a first-degree relative in case of patients unable to consent
- In case of women, unwillingness to remain pregnant during the study period achieved either by their partner using condom or by themselves using oral contraceptives.
- Confirmed infection by SARS-CoV-2 virus
- Infection of the upper respiratory tract or of the lower respiratory tract
Who cannot join
- Age below 18 years
- Denial of written informed consent
- Intake of any macrolide for the current episode of infection under study
- Intake of hydroxychloroquine or chloroquine phosphate.
- Presence of severe respiratory failure
- Oral or intravenous intake of corticosteroids defined as any more than 0.4mg/kg daily intake of equivalent prednisone for the last 15 days
Show all 10Show fewer
- Neutropenia defined as an absolute neutrophil count below 1,000/mm3
- Presence of any contraindications for the study drugs as stated in local label information
- QTc interval at rest electrocardiogram ≥500 msec or history of known congenital long QT syndrome
- Pregnancy or lactation
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Greece9 sites
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
Alexandroupoli, 68100
1st University Department of Internal Medicine, LAIKO General Hospital of Athens
Athens, 11527
2nd University Department of Internal Medicine, IPPOKRATEION General Hospital of Athens
Athens, 11527
3rd University Department of Internal Medicine, General Hospital of Chest Diseases of Athens I SOTIRIA
Athens, 11527
1st Department of Internal Medicine, General University Hospital of Ioannina
Ioannina, 45500
COVID-19 Department, General Hospital of Attica SISMANOGLEIO-AMALIA FLEMING
Marousi, Athens, 15126
2nd Department of Internal Medicine, General Hospital of Nikaia
Piraeus, Attica, 18454
2nd Department of Internal Medicine, General Hospital of Piraeus "Tzaneio"
Piraeus, 18536
1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki
Thessaloniki, 54621
About this study
Official title: Anti-inflammatory Clarithromycin to Improve SARS-CoV-2 (COVID-19) Infection Early: The ACHIEVE Open-label Non-randomized Clinical Trial
Recent information appearing from different countries suggest that treatment of Coronavirus disease 2019 (COVID-19) with hydroxychloroquine or with a combination of hydroxychloroquine and azithromycin has either an indifferent effect on viral replication or substantial cardiotoxicity. This is a clinical trial aiming to prove that addition of oral clarithromycin to treatment regimen of COVID-19 is associated with early clinical improvement and attenuation of the high inflammatory burden of the host. The study will not comprise a placebo-comparator group since this is considered inappropriate in an era of a pandemic with substantial global mortality.
Read the detailed description
Humanity is experiencing since December 2019 a new pandemic by the novel SARS Coronavirus-19 (SARS-CoV-2). As of March 25 2020 418,099 documented case were reported worldwide; 18,608 patients died. The analysis of the clinical characteristics of these patients showed that the natural course of this disease, known with the acronym COVID-19, is several times unpredictable. Most patients who develop pneumonia do not have worrying symptoms although their chest X-ray or chest computed tomography may be positive for diffuse infiltrates. Suddenly a certain proportion of these patients deteriorate into severe respiratory failure; this usually takes place between the 5th and the 10th day of illness and arrives without any preceding symptom. Published evidence suggests that this is due to the sudden arrival of an acute pro-inflammatory reaction of the host. With this in mind, it is reasonable to make the assumption than the early treatment with an agent that can efficiently modulate the host response and prevent sudden hyper-inflammatory reaction may prevent the development of severe respiratory failure (SRF).
The new guidelines published by the American Thoracic Society in 2019 clearly suggest that the management of community-acquired pneumonia (CAP) should rely on the combination of β-lactam antibiotics with macrolides. This position statement is pretty much influenced by the retrospective analyses of observational studies and of their meta-analyses in showing that the addition of a macrolide improves survival from severe CAP. Since patients leave in an era of antimicrobial resistance, it is profound that survival benefit is linked to the anti-inflammatory properties of the macrolide class of antibiotics. These properties are not only limited to the attenuation of the production of pro-inflammatory mediators but they involve the enhancement of pathogen clearance.
With this in mind, a small open-label trial among patients with COVID-19 showed better viral containment as assessed by the persistence of the virus in respiratory secretions, when patients were treated with a combination of azithromycin and hydroxychloroquine. However, the clinical benefit coming from this study has not yet been published. Contrary to azithromycin, clinical evidence suggests that clarithromycin is associated with substantial clinical benefit among critically ill patients. Two randomized clinical studies in a total of 800 patients with sepsis have shown 28-day survival benefit among the most severe cases. One of these studies enrolled patients with sepsis and ventilator-associated pneumonia; among 100 patients allocated to placebo treatment 40% survived until day 90; this was 57% among clarithromycin-treated patients.
In recent publication coming from the research network of the Hellenic Sepsis Study Group (HSSG) 130 patients with CAP were treated with a combination of β-lactam and clarithromycin. These patients were compared with 130 patients treated with a combination of β-lactam and azithromycin. Groups were well-matched for severity and comorbidities; 28-day mortality was 20.8% and 33.8% respectively.
Based on the above analysis, it seems likely that treatment of patients with COVID-19 with oral clarithromycin will substantially increase their anti-inflammatory properties and decrease the chances for development of severe respiratory failure.
As stated above, the efficacy of the treatment combination of hydroxychloroquine with azithromycin is based on results coming from only six patients. Since the publication of these data other, yet unpublished, reports have appeared in the internet challenging the treatment efficacy of this combination. These results show that treatment with hydroxychloroquine either single or in combination with azithromycin have either an indifferent effect on viral replication or even a deleterious effect on the patient due to cardiotoxicity. With this in mind it is obvious that macrolide treatment in COVID-19 patients many of which have coronary heart disease and chronic heart failure as comorbidities should be administered without hydroxychloroquine.
- Conditions
- COVID-19, Virus Diseases, Corona Virus Infection
- Being tested
- Clarithromycin
- Keywords
- COVID-19, SARS-CoV-2, Clarithromycin, Hydroxychloroquine
- Medical subject headings
- COVID-19, Virus Diseases, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
Also called Klaricid
Treatment with 500 mg Clarithromycin orally twice daily for seven days
| Study group | Role | What they receive |
|---|---|---|
| Clarithromycin arm | Experimental | Treatment will last for seven days. Every patient will receive one tablet of 500 mg of clarithromycin every 12 hours. It is explicitly stated that all other treatment is allowed with the only exclusion the parallel intake of a) any other drug of the macrolide class of antibiotics; and/or b) hydroxychloroquine or chloroquine phosphate. Drugs contraindicated with the intake of clarithromycin are also not allowed, as they are described in the local label information. Receives: Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome negative for two parameters(hospital admission/disease progression)
This is defined on day 8 (End of Treatment - EOT). Patients with upper respiratory tract infection by SARS-CoV-2 meet the study primary endpoint if they were not admitted to hospital or their symptoms did not progress to lower respiratory tract infection.
Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint.
Measured: Day 1 to Day 8
At least 50% change of the score of respiratory symptoms from the baseline
This is defined on day 8 (EOT visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the primary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain.
Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measured: Day 1 to Day 8
Secondary outcomes (16)
Comparison of two parameters with historical comparators from Hellenic Sepsis Study Group Database
Evaluation of need of hospitalization, SARS-CoV-2 infection progression from upper to lower respiratory tract infection, between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database
Measured: Day 1 to Day 8
Comparison of the score of respiratory symptoms with historical comparators from Hellenic Sepsis Study Group Database
Respiratory score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database.
This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain.Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measured: Day 1 to Day 8
Clinical outcome negative for two parameters(hospital admission/disease progression) on day 4
Comparison of clinical data (need of hospitalization, the infection progression of SARS-CoV-2 from upper to lower respiratory tract infections) in enrolled patients between baseline and study visit day 4 Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint.
Measured: Day 4
At least 50% change of the score of respiratory symptoms from the baseline on day 4
This is defined on day 4 (5th visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the secondary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain.
Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measured: Day 4
Range of development of severe respiratory failure
Evaluation of range of enrolled patients who develop severe respiratory failure between baseline and day 14 (TOC VISIT). Severe respiratory failure is defined by presence of all of the following
- pO2/FiO2 less than 150
- Need for mechanical or non-mechanical ventilation (CPAP)
Measured: Day 1 to Day 14
Range of hospital readmission until day 14
Evaluation of hospital readmission until day 14 (TOC VISIT) from enrollment defined as either need of re-hospitalization for discharged patients or any need for hospitalization of out-patients.
Measured: Day 1 to Day 14
Change of viral load in respiratory secretions from baseline on day 8
Comparison of Real Time - Polymerase Chain Reaction (RT-PCR) results for SARS-CoV-2 viral load in rhinopharyngeal samples of enrolled patients at days 1, 4 and 8
Measured: Day 1 to Day 8
Change of function of monocytes at days 1 and 8
Change of cytokine production of monocytes in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; monocytes will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of TNFα. This will be analyzed separately for patients with upper and with lower respiratory tract infection
Measured: Day 1 to Day 8
Change of function of Th1 cells at days 1 and 8
Change of cytokine production of Th1 cells in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; Th1 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IFNγ. This will be analyzed separately for patients with upper and with lower respiratory tract infection.
Measured: Day 1 to Day 8
Change of function of Th2 cells at days 1 and 8
Change of cytokine production of Th2 cells in enrolled patients with lower respiratory tract infection at days 1 and 8 (EOT) visit; Th2 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IL6. This will be analyzed separately for patients with upper and with lower respiratory tract infection.
Measured: Day 1 to Day 8
Change of serum interleukin-6 (IL-6) cytokine levels between days 1 and 8
Change of the serum levels of interleukin-6 (IL-6) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measured: Day 1 to day 8
Change of serum interleukin-8 (IL-8) cytokine levels between days 1 and 8
Change of the serum levels of interleukin-8 (IL-8) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measured: Day 1 to day 8
Change of serum human beta defensin-2 (hBD-2) between days 1 and 8
Change of the serum levels of human beta defensin-2 (hBD-2) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measured: Day 1 to day 8
Change of cytokine levels interleukin-6 (IL-6) at the rhinopharynx between days 1,4 and 8
Change of rhinopharynx levels of interleukin-6 (IL-6) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measured: Day 1 to day 8
Change of interleukin-1 (IL-1) cytokine levels at the rhinopharynx between days 1,4 and 8
Change of rhinopharynx levels of interleukin-1 (IL-1) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measured: Day 1 to day 8
Change of the IL-10/TNFα ratio between days 1 and 8
Comparison of the Interleukin-10/Tumor Necrosis Factor α (IL-10/TNFα) ratio in enrolled patients at days 1 and 8; this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measured: Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start6 May 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment with clarithromycin
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Institute for the Study of Sepsis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garyfallia Poulakou, MD, PhD, Principal investigator, National Kapodistrian University of Athens, Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398004
- Sponsor's protocol ID
- ACHIEVE
- Other IDs
- 2020-001882-36
- Acronym
- ACHIEVE
- Status last verified
- Jan 2021
- First submitted
- 17 May 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsiakos K, Tsakiris A, Tsibris G, Voutsinas PM, Panagopoulos P, Kosmidou M, Petrakis V, Gravvani A, Gkavogianni T, Klouras E, Katrini K, Koufargyris P, Rapti I, Karageorgos A, Vrentzos E, Damoulari C, Zarkada V, Sidiropoulou C, Artemi S, Ioannidis A, Papapostolou A, Michelakis E, Georgiopoulou M, Myrodia DM, Tsiamalos P, Syrigos K, Chrysos G, Nitsotolis T, Milionis H, Poulakou G, Giamarellos-Bourboulis EJ. Early Start of Oral Clarithromycin Is Associated with Better Outcome in COVID-19 of Moderate Severity: The ACHIEVE Open-Label Single-Arm Trial. Infect Dis Ther. 2021 Dec;10(4):2333-2351. doi: 10.1007/s40121-021-00505-8. Epub 2021 Aug 6.
PubMed 34363189
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Clarithromycin to Improve SARS-CoV-2 (COVID-19) Infection Early: The ACHIEVE Open-label Non-randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04398004
- Acronym / sponsor ID
- ACHIEVE / ACHIEVE
- Conditions
- COVID-19, Virus Diseases, Corona Virus Infection
- Keywords
- COVID-19, SARS-CoV-2, Clarithromycin, Hydroxychloroquine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hellenic Institute for the Study of SepsisUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 21 May 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.
Recent information appearing from different countries suggest that treatment of Coronavirus disease 2019 (COVID-19) with hydroxychloroquine or with a combination of hydroxychloroquine and azithromycin has either an indifferent effect on viral replication or substantial cardiotoxicity. This is a clinical trial aiming to prove that addition of oral clarithromycin to treatment regimen of COVID-19 is associated with early clinical improvement and attenuation of the high inflammatory burden of the host. The study will not comprise a placebo-comparator group since this is considered inappropriate in an era of a pandemic with substantial global mortality.
Detailed description
Humanity is experiencing since December 2019 a new pandemic by the novel SARS Coronavirus-19 (SARS-CoV-2). As of March 25 2020 418,099 documented case were reported worldwide; 18,608 patients died. The analysis of the clinical characteristics of these patients showed that the natural course of this disease, known with the acronym COVID-19, is several times unpredictable. Most patients who develop pneumonia do not have worrying symptoms although their chest X-ray or chest computed tomography may be positive for diffuse infiltrates. Suddenly a certain proportion of these patients deteriorate into severe respiratory failure; this usually takes place between the 5th and the 10th day of illness and arrives without any preceding symptom. Published evidence suggests that this is due to the sudden arrival of an acute pro-inflammatory reaction of the host. With this in mind, it is reasonable to make the assumption than the early treatment with an agent that can efficiently modulate the host response and prevent sudden hyper-inflammatory reaction may prevent the development of severe respiratory failure (SRF).
The new guidelines published by the American Thoracic Society in 2019 clearly suggest that the management of community-acquired pneumonia (CAP) should rely on the combination of β-lactam antibiotics with macrolides. This position statement is pretty much influenced by the retrospective analyses of observational studies and of their meta-analyses in showing that the addition of a macrolide improves survival from severe CAP. Since patients leave in an era of antimicrobial resistance, it is profound that survival benefit is linked to the anti-inflammatory properties of the macrolide class of antibiotics. These properties are not only limited to the attenuation of the production of pro-inflammatory mediators but they involve the enhancement of pathogen clearance.
With this in mind, a small open-label trial among patients with COVID-19 showed better viral containment as assessed by the persistence of the virus in respiratory secretions, when patients were treated with a combination of azithromycin and hydroxychloroquine. However, the clinical benefit coming from this study has not yet been published. Contrary to azithromycin, clinical evidence suggests that clarithromycin is associated with substantial clinical benefit among critically ill patients. Two randomized clinical studies in a total of 800 patients with sepsis have shown 28-day survival benefit among the most severe cases. One of these studies enrolled patients with sepsis and ventilator-associated pneumonia; among 100 patients allocated to placebo treatment 40% survived until day 90; this was 57% among clarithromycin-treated patients.
In recent publication coming from the research network of the Hellenic Sepsis Study Group (HSSG) 130 patients with CAP were treated with a combination of β-lactam and clarithromycin. These patients were compared with 130 patients treated with a combination of β-lactam and azithromycin. Groups were well-matched for severity and comorbidities; 28-day mortality was 20.8% and 33.8% respectively.
Based on the above analysis, it seems likely that treatment of patients with COVID-19 with oral clarithromycin will substantially increase their anti-inflammatory properties and decrease the chances for development of severe respiratory failure.
As stated above, the efficacy of the treatment combination of hydroxychloroquine with azithromycin is based on results coming from only six patients. Since the publication of these data other, yet unpublished, reports have appeared in the internet challenging the treatment efficacy of this combination. These results show that treatment with hydroxychloroquine either single or in combination with azithromycin have either an indifferent effect on viral replication or even a deleterious effect on the patient due to cardiotoxicity. With this in mind it is obvious that macrolide treatment in COVID-19 patients many of which have coronary heart disease and chronic heart failure as comorbidities should be administered without hydroxychloroquine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment with clarithromycin
| Arm | Type | Receives |
|---|---|---|
| Clarithromycin arm | Experimental | Drug: ClarithromycinTreatment will last for seven days. Every patient will receive one tablet of 500 mg of clarithromycin every 12 hours. It is explicitly stated that all other treatment is allowed with the only exclusion the parallel intake of a) any other drug of the macrolide class of antibiotics; and/or b) hydroxychloroquine or chloroquine phosphate. Drugs contraindicated with the intake of clarithromycin are also not allowed, as they are described in the local label information. |
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 years
- Male of female gender
- Written informed consent provided by the patients or by a first-degree relative in case of patients unable to consent
- In case of women, unwillingness to remain pregnant during the study period achieved either by their partner using condom or by themselves using oral contraceptives.
- Confirmed infection by SARS-CoV-2 virus
Key exclusion criteria (10 listed)
- Age below 18 years
- Denial of written informed consent
- Intake of any macrolide for the current episode of infection under study
- Intake of hydroxychloroquine or chloroquine phosphate.
- Presence of severe respiratory failure
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 |
|---|---|---|
| ClarithromycinAlso: KlaricidTreatment with 500 mg Clarithromycin orally twice daily for seven days | Drug | Clarithromycin arm |
Primary outcome
Clinical outcome negative for two parameters(hospital admission/disease progression)
Time frame: Day 1 to Day 8
This is defined on day 8 (End of Treatment - EOT). Patients with upper respiratory tract infection by SARS-CoV-2 meet the study primary endpoint if they were not admitted to hospital or their symptoms did not progress to lower respiratory tract infection. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint.
At least 50% change of the score of respiratory symptoms from the baseline
Time frame: Day 1 to Day 8
This is defined on day 8 (EOT visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the primary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
16 secondary outcomes
Comparison of two parameters with historical comparators from Hellenic Sepsis Study Group Database
Time frame: Day 1 to Day 8
Comparison of the score of respiratory symptoms with historical comparators from Hellenic Sepsis Study Group Database
Time frame: Day 1 to Day 8
Clinical outcome negative for two parameters(hospital admission/disease progression) on day 4
Time frame: Day 4
At least 50% change of the score of respiratory symptoms from the baseline on day 4
Time frame: Day 4
Range of development of severe respiratory failure
Time frame: Day 1 to Day 14
Range of hospital readmission until day 14
Time frame: Day 1 to Day 14
Change of viral load in respiratory secretions from baseline on day 8
Time frame: Day 1 to Day 8
Change of function of monocytes at days 1 and 8
Time frame: Day 1 to Day 8
Change of function of Th1 cells at days 1 and 8
Time frame: Day 1 to Day 8
Change of function of Th2 cells at days 1 and 8
Time frame: Day 1 to Day 8
Change of serum interleukin-6 (IL-6) cytokine levels between days 1 and 8
Time frame: Day 1 to day 8
Change of serum interleukin-8 (IL-8) cytokine levels between days 1 and 8
Time frame: Day 1 to day 8
Change of serum human beta defensin-2 (hBD-2) between days 1 and 8
Time frame: Day 1 to day 8
Change of cytokine levels interleukin-6 (IL-6) at the rhinopharynx between days 1,4 and 8
Time frame: Day 1 to day 8
Change of interleukin-1 (IL-1) cytokine levels at the rhinopharynx between days 1,4 and 8
Time frame: Day 1 to day 8
Change of the IL-10/TNFα ratio between days 1 and 8
Time frame: Day 1 to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Derived from this study: PubMed 34363189Tsiakos K, Tsakiris A, Tsibris G, Voutsinas PM, Panagopoulos P, Kosmidou M, Petrakis V, Gravvani A, Gkavogianni T, Klouras E, Katrini K, Koufargyris P, Rapti I, Karageorgos A, Vrentzos E, Damoulari C, Zarkada V, Sidiropoulou C, Artemi S, Ioannidis A, Papapostolou A, Michelakis E, Georgiopoulou M, Myrodia DM, Tsiamalos P, Syrigos K, Chrysos G, Nitsotolis T, Milionis H, Poulakou G, Giamarellos-Bourboulis EJ. Early Start of Oral Clarithromycin Is Associated with Better Outcome in COVID-19 of Moderate Severity: The ACHIEVE Open-Label Single-Arm Trial. Infect Dis Ther. 2021 Dec;10(4):2333-2351. doi: 10.1007/s40121-021-00505-8. Epub 2021 Aug 6.
- Individual participant dataSharing planned: No
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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.
Garyfallia Poulakou, MD, PhD principal investigator
National Kapodistrian University of Athens, Medical School
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clarithromycin in people with COVID-19 and Virus Diseases, run by Hellenic Institute for the Study of Sepsis at 9 sites in Greece.
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 10 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: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical outcome negative for two parameters(hospital admission/disease progression) (time frame: Day 1 to Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398004, which also lists 1 linked publication.
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 11 Jan 2021.