Last reviewed · How we verify
NCT04944329: COLCOVID
Hip Fracture and COVID-19
trial testing Hip fracture surgery in SARS-CoV2 Infection in 73,661 participants. Completed in 31 December 2020.
31 December 2020
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Nīmes |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 73,661 |
| Start date | 1 March 2020 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across France |
Drugs / interventions tested
- Hip fracture surgery
Conditions studied
- SARS-CoV2 Infection — all drugs for SARS-CoV2 Infection →
- Hip Fractures — all drugs for Hip Fractures →
- Surgery — all drugs for Surgery →
Sponsor
Centre Hospitalier Universitaire de Nīmes
Who can join
65 and older, any sex, with SARS-CoV2 Infection or Hip Fractures. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hip fracture in the elderly is a worldwide public health issue and a medical challenge for early postoperative rehabilitation. More than 2 million people are treated annually with an annual incidence between 100 and 300/100,000 (USA, Europe, China), resulting in a cost of billion dollars and a strain on most surgical facilities. In this context, an early surgical management of patient with fracture within the first 24-48h has been shown to reduce morbidity, length of hospital stay and mortality. During the Covid-19 pandemics, a higher risk of 30-day mortality has been reported in patients with pre-operative SARS-CoV-2 infection diagnosed 0-2 weeks, 3-4 weeks and 5-6 weeks before surgery compared with patients who did not have a pre-operative SARS-CoV-2 infection. However, this risk seems to disappear in patients diagnosed with SARS-CoV-2 ≥ 7 weeks before surgery. These findings led to propose delayed elective surgery when the benefit-risk ratio was acceptable (cancer, cardiac surgeries). However, delaying surgery in COVID-19 patients (with high risk of immune and thrombotic disorders) with hip fracture could be questionable as the risk related to COVID-19 could be counteracted by the risk delayed surgery. For assessing the mortality risk related to hip fracture surgery associated with COVID-19, we decided to use the French national hospital discharge records database for comparing the 30-day postoperative mortality in patients with hip fracture and with or without an hospitalization for SARS-COV-2 infection in the 30 previous days before surgery.
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 NCT04944329
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Hip fracture surgery
Trials testing the same drug.
- NCT05060614 — Analyses of Cerebrospinalfluid in Patients With Delirium · recruiting
Other recruiting trials for SARS-CoV2 Infection
Currently open trials in the same condition.
- NCT05852873 — PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway · Phase 3 · active not recruiting
- NCT04910269 — Outpatient Treatment With Anti-Coronavirus Immunoglobulin · Phase 3 · recruiting
- NCT04830852 — Pediatric COVID Outcomes Study (PECOS) · active not recruiting
- NCT04844242 — MISC COVID-19 Study in Pediatric Population · recruiting
Other Centre Hospitalier Universitaire de Nīmes trials
Trials by the same sponsor.
- NCT07403474 — Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Ther · Phase 4 · not yet recruiting
- NCT07455981 — Work Organization and Gambling Addiction · not yet recruiting
- NCT07403500 — Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain. · NA · not yet recruiting
- NCT07342010 — Bicarbonate Addition to Lidocaine-Epinephrine in Surgery Under WALANT · Phase 4 · not yet recruiting
- NCT07305727 — A Radiomic MRI Predictive Model for Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer · recruiting
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 NCT04944329 (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 Centre Hospitalier Universitaire de Nīmes
- Last refreshed: 1 July 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/NCT04944329.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing