NCT04398004 (ACHIEVE) is a Phase 2 clinical trial of Clarithromycin in COVID-19, sponsored by Hellenic Institute for the Study of Sepsis.

Who is sponsoring NCT04398004?

NCT04398004 is sponsored by Hellenic Institute for the Study of Sepsis.

What drugs are being tested in NCT04398004?

Interventions in NCT04398004: Clarithromycin.

What condition does NCT04398004 study?

NCT04398004 studies COVID-19, Virus Diseases, Corona Virus Infection.

Is NCT04398004 still recruiting?

NCT04398004 is currently completed. Last updated 11 January 2021.

Last reviewed 2021-01-11 · How we verify

NCT04398004: ACHIEVE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Anti-inflammatory Clarithromycin for Improving COVID-19 Infection Early

Completed Phase 2 Last updated 11 January 2021

What this trial tests

Phase 2 trial testing Clarithromycin in COVID-19 in 90 participants. Completed in 30 November 2020.

Timeline

6 May 2020

Primary endpoint
30 November 2020

30 November 2020

Quick facts

Lead sponsor	Hellenic Institute for the Study of Sepsis
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	90
Start date	6 May 2020
Primary completion	30 November 2020
Estimated completion	30 November 2020
Sites	9 locations across Greece

Drugs / interventions tested

Clarithromycin (clarithromycin) — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →
Virus Diseases — all drugs for Virus Diseases →
Corona Virus Infection — all drugs for Corona Virus Infection →

Sponsor

Hellenic Institute for the Study of Sepsis

Who can join

18 and older, any sex, with COVID-19 or Virus Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
Potential Anti-COVID-19 Therapeutics that Block the Early Stage of the Viral Life Cycle: Structures, Mechanisms, and Clinical Trials.
Al-Horani RA, Kar S, Aliter KF. · · 2020 · cited 35× · PMID 32718020 · DOI 10.3390/ijms21155224
Early Start of Oral Clarithromycin Is Associated with Better Outcome in COVID-19 of Moderate Severity: The ACHIEVE Open-Label Single-Arm Trial.
Tsiakos K, Tsakiris A, Tsibris G, Voutsinas PM, et al · · 2021 · cited 12× · PMID 34363189 · DOI 10.1007/s40121-021-00505-8
The Role of Macrolides for the Management of Community-Acquired Pneumonia and Pneumonia by the Novel Coronavirus SARS-CoV-2 (COVID-19): A Position Paper by Four Medical Societies from Greece.
Giamarellos-Bourboulis EJ, Daikos GL, Gargalianos P, Gogos C, et al · · 2021 · cited 2× · PMID 34137001 · DOI 10.1007/s40121-021-00471-1
Expanding Our Understanding of COVID-19 from Biomedical Literature Using Word Embedding.
Yang H, Sohn E. · · 2021 · cited 2× · PMID 33804131 · DOI 10.3390/ijerph18063005
The Role of Macrolides for the Management of Community-Acquired Pneumonia and Pneumonia by the Novel Coronavirus SARS-CoV-2 (COVID-19): A Position Paper by Four Medical Societies from Greece.
Giamarellos-Bourboulis EJ, Daikos GL, Gargalianos P, Gogos C, et al · · 2021 · PMID 34155472 · DOI 10.1007/s40121-021-00471-1
Early start of oral clarithromycin is associated with better outcome in COVID-19 of moderate severity: the ACHIEVE open-label trial
Tsiakos K, Tsakiris A, Tsibris G, Voutsinas P, et al · · 2020 · DOI 10.1101/2020.12.22.20248753

Verify or expand the search:

Other trials of Clarithromycin

Trials testing the same drug.

NCT07040787 — Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects · Phase 1 · completed
NCT07086937 — Efficacy of Nitazoxanide Based Therapy vs Standard Triple Therapy in H-pylori in Children · NA · completed
NCT06514274 — Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Era · Phase 4 · completed
NCT06551623 — Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin · Phase 1 · completed
NCT06576882 — 7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication · Phase 3 · completed

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other Hellenic Institute for the Study of Sepsis trials

Trials by the same sponsor.

NCT06608849 — The Incidence of Pulmonary, Cardiovascular and Renal System Non-communicable Complications Associated With the Post-acut · recruiting
NCT06601998 — Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19. · recruiting
NCT07073456 — Viscoelastic Coagulation for Early Sepsis Detection · recruiting
NCT06294600 — Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT) · Phase 3 · recruiting
NCT06141395 — NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04398004 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hellenic Institute for the Study of Sepsis
Last refreshed: 11 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04398004.

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