NCT04347512: TEACHCOVID

EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA

Withdrawn Phase 3 Last updated 4 June 2020

What this trial tests

Phase 3 trial testing Hydroxychloroquine and azithromycin treatment arm. in Sars-CoV-2, Community-Acquired Pneumonia,COVID-19. Withdrawn.

Timeline

2 June 2020

Primary endpoint
2 June 2020

2 June 2020

Quick facts

Lead sponsor	University Hospital, Strasbourg, France
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	2 June 2020
Primary completion	2 June 2020
Estimated completion	2 June 2020

Drugs / interventions tested

• Hydroxychloroquine and azithromycin treatment arm. — full drug profile →
• Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →
• Control arm

Conditions studied

• Sars-CoV-2, Community-Acquired Pneumonia,COVID-19 — all drugs for Sars-CoV-2, Community-Acquired Pneumonia,COVID-19 →

Sponsor

University Hospital, Strasbourg, France

Who can join

18 and older, any sex, with Sars-CoV-2, Community-Acquired Pneumonia,COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Since end of December, a new coronavirus, close to the 2002 SARS coronavirus, cause serious pneumonias throughout world. There is currently no strong evidence of an efficient specific treatment. Hydroxychloroquine is an old chloroquine-derived drug, prescribed for auto-immune disorders. It has shown efficacy against Sars-CoV-2 in vitro. Some studies showed that Hydroxychloroquine might improve the clinical status of Sars-CoV-2 infected patients. Azithromycin is a macrolide antibiotic, with immunomodulatory properties. Adding Azithromycin to a hydroxychloroquine-based treatment showed an apparent accelerated viral clearance in infected patients. This study wants to evaluate the clinical impact of adding Azithromycin to Hydroxychloroquine in the treatment of Sars-CoV-2 pneumonia

Publications & conference data

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

1. Macrolides and viral infections: focus on azithromycin in COVID-19 pathology.
   Pani A, Lauriola M, Romandini A, Scaglione F. · · 2020 · cited 73× · PMID 32534189 · DOI 10.1016/j.ijantimicag.2020.106053
2. Widely available lysosome targeting agents should be considered as potential therapy for COVID-19.
   Homolak J, Kodvanj I. · · 2020 · cited 54× · PMID 32522674 · DOI 10.1016/j.ijantimicag.2020.106044
3. Hydroxychloroquine in COVID-19: Potential Mechanism of Action Against SARS-CoV-2.
   Satarker S, Ahuja T, Banerjee M, E VB, et al · · 2020 · cited 50× · PMID 32864299 · DOI 10.1007/s40495-020-00231-8
4. SARS-CoV-2 Treatment Approaches: Numerous Options, No Certainty for a Versatile Virus.
   Iacob S, Iacob DG. · · 2020 · cited 27× · PMID 32982720 · DOI 10.3389/fphar.2020.01224
5. Inhaled hydroxychloroquine to improve efficacy and reduce harm in the treatment of COVID-19.
   Kavanagh O, Marie Healy A, Dayton F, Robinson S, et al · · 2020 · cited 26× · PMID 33017904 · DOI 10.1016/j.mehy.2020.110110
6. Current status and strategic possibilities on potential use of combinational drug therapy against COVID-19 caused by SARS-CoV-2.
   Siddiqui AJ, Jahan S, Ashraf SA, Alreshidi M, et al · · 2021 · cited 25× · PMID 32752944 · DOI 10.1080/07391102.2020.1802345
7. Rationale of a loading dose initiation for hydroxychloroquine treatment in COVID-19 infection in the DisCoVeRy trial.
   Lê MP, Peiffer-Smadja N, Guedj J, Néant N, et al · · 2020 · cited 21× · PMID 32473020 · DOI 10.1093/jac/dkaa191
8. Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.
   Mathioudakis AG, Fally M, Hashad R, Kouta A, et al · · 2020 · cited 14× · PMID 33333777 · DOI 10.3390/life10120350