CLARITHROMYCIN IN COVID-19

ANTI-INFLAMMATORY CLARITHROMYCIN TO IMPROVE SARS-CoV-2 (COVID-19) INFECTION EARLY: THE ACHIEVE OPEN-LABEL NON-RANDOMIZED CLINICAL TRIAL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001882-36-GR

Enrollment

Registered

2020-04-30

Start date

2020-05-07

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Management of infection by SARS-CoV-2 (COVID-19) MedDRA version: 20.0 Level: LLT Classification code 10035738 Term: Pneumonia viral NOS System Organ Class: 100000004862

Interventions

Trade Name: Klaricid Product Name: Clarithromycin Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: • Age below 18 years • Denial of written informed consent • Presence of severe respiratory failure • Intake of any macrolide for the current episode of infection under study • Intake of hydroxychloroquine or chloroquine phosphate. • Oral or intravenous intake of corticosteroids defined as any more than 0.4mg/kg daily intake of equivalent prednisone for the last 3 days • 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 ECG =500 msec or history of known congenital long QT syndrome • Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: Recent information appearing from different countries suggest that treatment of 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.;Secondary Objective: Not applicable;Primary end point(s): This is defined on day 8 (EOT visit). This is a composite score since it is defined differently for patients with upper respiratory tract infection or lower respiratory tract infection by SARS-CoV-2. • For patients with an upper respiratory tract infection this is defined as no need for hospital admission in case of earlier discharge or as lack of progression into lower respiratory tract infection. • For patients with a lower respiratory tract infection this is defined as 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;Timepoint(s) of evaluation of this end point: Day 8	—

Measure

Time frame

Main Objective: Recent information appearing from different countries suggest that treatment of 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.;Secondary Objective: Not applicable;Primary end point(s): This is defined on day 8 (EOT visit). This is a composite score since it is defined differently for patients with upper respiratory tract infection or lower respiratory tract infection by SARS-CoV-2. • For patients with an upper respiratory tract infection this is defined as no need for hospital admission in case of earlier discharge or as lack of progression into lower respiratory tract infection. • For patients with a lower respiratory tract infection this is defined as 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;Timepoint(s) of evaluation of this end point: Day 8

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Secondary

Measure	Time frame
Secondary end point(s): • Comparison of the primary endpoint with historical comparators • Evaluation of the conditions composing the primary study endpoint on day 4 (visit 5) from start of treatment • Development of severe respiratory failure (TOC visit) • Hospital readmission until day 14 (TOC) defined as either need of re-hospitalization for discharged patients or any need for hospitalization of out-patients. • Change of viral load from baseline in respiratory secretions on days 4 and 7 • Change of function of monocytes, Th1 and Th2 at the EOT; this is also analyzed separately for patients with upper and with lower respiratory tract infection • Change of the serum levels of IL-6, IL-8 and hBD-2 defined as above at the EOT visit; this is also analyzed separately for patients with upper and with lower respiratory tract infection • Change of the IL-10/TNFa ratio defined as above at the EOT visit; this is also analyzed separately for patients with upper and with lower respiratory tract infection • Change of the concentrations of IL-1 and IL-6 at rhinopharynx on days 4 and EOT; this is also analyzed separately for patients with upper and with lower respiratory tract infection;Timepoint(s) of evaluation of this end point: Day 4 Day 8 Day 14	—

Measure

Time frame

Secondary end point(s): • Comparison of the primary endpoint with historical comparators • Evaluation of the conditions composing the primary study endpoint on day 4 (visit 5) from start of treatment • Development of severe respiratory failure (TOC visit) • Hospital readmission until day 14 (TOC) defined as either need of re-hospitalization for discharged patients or any need for hospitalization of out-patients. • Change of viral load from baseline in respiratory secretions on days 4 and 7 • Change of function of monocytes, Th1 and Th2 at the EOT; this is also analyzed separately for patients with upper and with lower respiratory tract infection • Change of the serum levels of IL-6, IL-8 and hBD-2 defined as above at the EOT visit; this is also analyzed separately for patients with upper and with lower respiratory tract infection • Change of the IL-10/TNFa ratio defined as above at the EOT visit; this is also analyzed separately for patients with upper and with lower respiratory tract infection • Change of the concentrations of IL-1 and IL-6 at rhinopharynx on days 4 and EOT; this is also analyzed separately for patients with upper and with lower respiratory tract infection;Timepoint(s) of evaluation of this end point: Day 4 Day 8 Day 14

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Countries

Greece

Contacts

Public ContactPresident of the Board

Hellenic Institute for the Study of Sepsis

insepsis@otenet.gr+302107480662

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026