Observational Cohort of COVID-19 Patients at Raymond-Poincare

COVID-19 Clinical Trial

— COVID-RPC  

Official title:

Observational Cohort of COVID-19 Patients at Raymond-Poincare

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04364698
• Other study ID #: 20SBS-COVID-RPC
• Status: Recruiting
• Start date: May 7, 2020
• Est. completion date: June 2020

Study information

• Verified date: May 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Aurelien Dinh, MD
• Phone: +33 1 47 10 77 74
• Email: Aurelien.dinh[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The SARS-CoV-2 infection detected in China in December 2019 is responsible for the current COVID-19 pandemic affecting nearly 1.2 million people worldwide to date. Infection with this virus of the coronavirus family is causing a broad clinical spectrum, the main manifestation of which is an influenza-like condition associated with a pattern of severe hypoxemia pneumonia, and in some cases fatal. Little is known about this pathology, so we propose to carry out an observational cohort of patients treated in our hospital for an SARS-CoV-2 infection.

This cohort should make it possible to clinically, biologically and radiologically characterize the SARS-CoV-2 infections. We will also collect the therapeutic strategies implemented, their possible toxicity and the evolution of the patients.

Description:

COVID-19 is a virus belonging to the coronavirus family, which includes a large number of viruses that can cause a wide variety of diseases in humans. The SARS-CoV-2 virus that caused the current COVID-19 pandemic, although widely described in the literature, still has many grey areas. The main clinical manifestation is an influenza-like illness associated with respiratory tract infection that can lead to severe hypoxemic pneumonia with fatal outcomes in 2.3% of cases. The clinical spectrum is not yet very well known, as evidenced by the evidence of anosmia, agueusia, or recent skin manifestations, but also strong suspicion of possible neurological damage. Similarly, it is not yet very well established, apart from certain co-morbidities, which patients are likely to develop serious forms requiring admission to intensive care, as shown by the proportion of patients < 60 years of age admitted to intensive care for ARDS.

Moreover, the question of how to manage these patients still raises many questions, particularly about the type of molecules to be introduced and at what point in the history of the disease. Some of these molecules, such as the Lopinavir/Ritonavir combinations and the Hydroxychloroquine/ Azithromycin combination, are not free of complications, particularly cardiac complications requiring close monitoring by ECGs and repeated dosing, the effectiveness of which has not yet been clearly demonstrated.

In order to better understand this infection, we propose to set up a cohort of patients treated for CoV-2 SARS infection on our site.

Study scheme:

Longitudinal cohort study of patients with confirmed or strongly suspected CoV-2 SARS infection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patient = 18 years old

• SARS-CoV-2 infection confirmed by PCR or strongly suspected on compatible radio-clinical grounds during an epidemic period.

Exclusion criteria:

• Not able to express their opposition

• Patient under guardianship or curatorship

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
France	Department of Infectiology, Raymond Poincaré Hospital, APHP	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (6)

Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18. — View Citation

Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Dupont HT, Honoré S, Colson P, Chabrière E, La Scola B, Rolain JM, Brouqui P, Raoult D. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Mar 20:105949. doi: 10.1016/j.ijantimicag.2020.105949. [Epub ahead of print] — View Citation

Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 17;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. [Epub ahead of print] Chinese. — View Citation

Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26. Review. — View Citation

Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Feb 7. doi: 10.1001/jama.2020.1585. [Epub ahead of print] — View Citation

Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical, biological and radiological characteristics	Describe the clinical, biological and radiological characteristics of COVID-19 patients hospitalized in our center.	through study completion, an average of 1 month
Secondary	patients' journey description	Describe the patients' journey through our structure.	through study completion, an average of 1 month
Secondary	Treatments effects	Describe the clinical course of patients treated with the hydroxychloroquine/azithromycin combination in a compassionate context and the side effects observed.	through study completion, an average of 1 month