- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04916561
Detection of Covid-19 in Tissue Samples of Orthopedic Origin
Detection of Covid-19 in Tissue Samples of Orthopedic Origin: a Prospective Cohort Study
Background The presence of the Covid-19 virus has been detected in tissues of various origins: nasopharyngeal swabs, sputum, bronchoalveolar fluid, blood, stool and anal swabs. However, it does not appear that the virus is excreted in the urine. The REACTing group (Research & Action Emerging Infectious Diseases) has demonstrated the presence of the virus in the conjunctiva and pleural fluid. This detection was made possible by carrying out quantitative, real-time RT-PCR and sequencing of the viral genes, which are currently the benchmark for the diagnosis of COVID-19. However, it is not known at this time whether the Covid-19 virus is present in joint fluid or in bone.
However, some viruses have a particular bone tropism (Parvovirus B19, HHV6); others have joint tropism (parvovirus B19, HBV, HCV, rubella, HIV, HTLV-1). The presence in "orthopedic" tissues of the various coronaviruses (MERS, SARS, etc.) has never been evaluated in the past. However, cases of pulmonary contamination by coronavirus after bone marrow transplantation have been reported in the literature. A potential location at these levels could cause problems of different kinds.
Rationale First, and concretely, a possible direct transmission by these tissues. The current English and Spanish national recommendations in orthopedics show a controversy as to the risk of intraoperative contamination during medical procedures generating aerosols, in particular those involving instruments at high speed (saw blade, reamer, drill). This transmission could also be a problem during bone marrow transplants, from the iliac crests, for example.
Second, but hypothetically, Covid-19 could become quiescent at the level of the myelo-hematopoietic niches and reactivate at a distance, which could then explain the current interrogation on "absence of immunity" and cases of early revival in patients considered cured. This hypothesis is all the more likely since, always by analogy with Parvovirus B19 or HHV6, a recent alert on cases of myocarditis in children has been issued in Parisian pediatric hospitals and that treatment with tocilizumab, which blocks the action Interleukin 6 receptors, and initially used for joint manifestations of rheumatoid arthritis, appear promising.
Přehled studie
Detailní popis
- Objective: The objective is to determine if Covid-19 is present in bone and joint tissue from operative parts, extracted during routine procedures, in patients diagnosed with Covid + before the procedure.
- Methods: Sample form orthopedics procedure that is usually collected will be analysed for the detection of Covid-19
- Hypothesis: The presence of the virus in the blood suggests a variable amount of presence in the bone tissues, and to a lesser extent articular, of the weakness of their poor vascularity.
Nevertheless, if this is confirmed, understanding of the natural history of the disease would be greatly improved.In the absence of a virus, this would end the controversy about the possibility of contamination by accident from exposure to the block and modify the national recommendations for good orthopedic practices.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Paris, Francie, 75011
- Université de Paris
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- patients eligible for traumatology or orthopedics procedure.
- > 18 years-old with no upper age limit
- diagnosed Covid+ using RT-PCR during the past one month
Exclusion Criteria:
- Pregnant or lactating women or in age to procreate without contraceptive treatment
- History of mental illness or neurological deficit or adults lacking capacity to consent for themselves
- Prisoners or young offenders
- Persons who might not adequately understand verbal explanations or written information given in French, or who have special communication needs
- Subjects having been or being under an infectious or oncological intercurrent disorder
- Heart failure with risk of exercise angina or comorbidity(ies) significantly affecting patient function
- Any participants who are involved in current research or have recently been involved in any research prior to recruitment.
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
positive detection rate
Časové okno: immediately after surgery
|
rate of patients with possible detection of the virus in an orthopedic sample
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immediately after surgery
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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viremia
Časové okno: immediately after surgery
|
virus detection levels in the blood
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immediately after surgery
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Cedric Maillot, MD, APHP
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- CovidOS_2020
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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