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NCT04452617
Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19
trial in COVID-19 in 40 participants. Completed in 1 July 2020.
8 April 2020
Quick facts
| Lead sponsor | Institut Mutualiste Montsouris |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 19 March 2020 |
| Primary completion | 8 April 2020 |
| Estimated completion | 1 July 2020 |
| Sites | 1 location across France |
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
Institut Mutualiste Montsouris — full company profile →
Who can join
18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but few reports have assessed this combination therapy in critically ill COVID-19 patients. Many raised concerns regarding the potential cardiac toxicity of this association. The purpose of this monocenter retrospective observational study is to evaluate the safety of a short term treatment with hydroxychloroquine and azithromycin in critically ill patients admitted in ICU for severe COVID-19 with respiratory failure. The main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de pointes and cardiac arrest or sudden death, during the treatment period.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04452617
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Institut Mutualiste Montsouris trials
Trials by the same sponsor.
- NCT06982625 — Supra Inguinal Fascia Iliaca Block as Rescue Analgesia Following Total Hip Arthroplasty · NA · recruiting
- NCT06007274 — Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors · completed
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- NCT05799898 — Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors · recruiting
- NCT05301218 — CAlcified Lesion Intervention Planning Steered by OCT. · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04452617 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut Mutualiste Montsouris
- Last refreshed: 1 September 2020
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/NCT04452617.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing