- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04554979
COVID-19 Disease Duration and GIT Manifestations. A New Disease Severity Classification. An Egyptian Experience
Corona Virus (COVID-19) Disease Duration and Gastrointestinal Tract (GIT) Manifestations; Can be New Disease Severity Classification. A Pilot Egyptian Single National Center Experience
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
This observational retrospective cohort single center national study was conducted on patients who tested positive COVID-19 infection by the polymerase chain reaction (PCR) of nasopharyngeal sample in the period from first June to the med of July 2020. Patients were recruited from Kasr Al-Aini School of medicine, COVID-19 out-patient clinic, Cairo University hospitals.
The diagnosis and classification of severity of COVID-19 infection were made according to the clinical management of COVID-19, released by the World Health Organization (WHO), mild and moderate case were recruited, the treatment protocol used was according to the Egyptian ministry of health treatment recommendations, which met in part the criteria that was later on published by the national institute of health, Mild and moderate cases once diagnosed by PCR received hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started till result of sputum culture and sensitivity. Steroids were initiated in hypoxic cases that required supplemental oxygen and in cases of persistent symptoms.
Any adult patient (age ≥18 years) suffering from mild or moderate COVID-19 infection was included in this study. While severe cases according to WHO classifications and patients aged less than18 were excluded from the study.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Cairo, Egypte
- Faculty of medicine cairo university
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Mild and moderate COVID-19 patients:
Exclusion Criteria:
- Age less than 18 years
- Severe COVID-19 patients: with dyspnea, hypoxia, or >50 percent lung involvement on imaging within 24 to 48 hours
- Critical COVID-19 patients: with respiratory failure, shock, or multiorgan dysfunction
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Rétrospective
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Group 1
Duration of COVID-19 symptoms less than 12 days
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hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases.
Also they received anticoagulants, vitamin c and zinc.
In case of secondary bacterial infection, empiric antibiotics are started
Autres noms:
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Group 2
Duration of COVID-19 symptoms equal or more than 12 days
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hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases.
Also they received anticoagulants, vitamin c and zinc.
In case of secondary bacterial infection, empiric antibiotics are started
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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COVID-19 disease spectrum and duration
Délai: july 2020 to june 2020
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The investigators tried to correlate disease severity with disease duration
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july 2020 to june 2020
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GIT manifestations among COVID-19 patients
Délai: july 2020 to june 2020
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spectrum of GIT manifestations in COVID-19 patients was investigated
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july 2020 to june 2020
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Non-communicable disease and COVID-19
Délai: july 2020 to june 2020
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The link between non-communicable disease (including diabetes, hypertension and Hypercholesterolemia) severity and COVID-19 prognosis
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july 2020 to june 2020
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Seasonal change and COVID-19
Délai: july 2020 to june 2020
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the investigators studied the Impact of weather climate on COVID-19 presentations (higher incidence of diarrhea in COVID-19 patients in summer) and outcomes
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july 2020 to june 2020
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Possible region specific classification for COVID-19 disease
Délai: july 2020 to june 2020
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The investigators tried to find new Egyptian classification fro COVID-19 disease severity
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july 2020 to june 2020
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mona M Hegazy, MD, Professor of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University
- Directeur d'études: Ahmed M Abdul Ghani, MD, Lecturer of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University
- Chaise d'étude: Rania M Lithy, MD, Lecturer of Endemic medicine and hepatogastroenterology. Faculty of medicine Cairo University
- Chaise d'étude: Hoda M abdel-Hamid, MD, Lecturer of Respiratory medicine. Faculty of medicine Cairo University
- Chaise d'étude: Mahmoud Wahba, MD, Lecturer of Internal Medicine Division of Gastroenterology, Kasr Alainy . Faculty of Medicine, Cairo University
- Chaise d'étude: Omar Ashoush, MD, Lecturer of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University
- Chaise d'étude: Mohamed Tharwat Hegazy, MD, Lecturer of Internal Medicine Department, Rheumatology and Clinical Immunology unit, Faculty of Medicine, Cairo University
Publications et liens utiles
Publications générales
- Pan L, Mu M, Yang P, Sun Y, Wang R, Yan J, Li P, Hu B, Wang J, Hu C, Jin Y, Niu X, Ping R, Du Y, Li T, Xu G, Hu Q, Tu L. Clinical Characteristics of COVID-19 Patients With Digestive Symptoms in Hubei, China: A Descriptive, Cross-Sectional, Multicenter Study. Am J Gastroenterol. 2020 May;115(5):766-773. doi: 10.14309/ajg.0000000000000620.
- Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- 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 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
- Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
- 1.World Health Organization. Novel coronavirus (2019-nCoV): situation report-40. Available at: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200229-sitrep-40-covid-19.pdf. Accessed 29 February 2020.
- Hoehl S, Rabenau H, Berger A, Kortenbusch M, Cinatl J, Bojkova D, Behrens P, Boddinghaus B, Gotsch U, Naujoks F, Neumann P, Schork J, Tiarks-Jungk P, Walczok A, Eickmann M, Vehreschild MJGT, Kann G, Wolf T, Gottschalk R, Ciesek S. Evidence of SARS-CoV-2 Infection in Returning Travelers from Wuhan, China. N Engl J Med. 2020 Mar 26;382(13):1278-1280. doi: 10.1056/NEJMc2001899. Epub 2020 Feb 18. No abstract available.
- Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.
- Jin X, Lian JS, Hu JH, Gao J, Zheng L, Zhang YM, Hao SR, Jia HY, Cai H, Zhang XL, Yu GD, Xu KJ, Wang XY, Gu JQ, Zhang SY, Ye CY, Jin CL, Lu YF, Yu X, Yu XP, Huang JR, Xu KL, Ni Q, Yu CB, Zhu B, Li YT, Liu J, Zhao H, Zhang X, Yu L, Guo YZ, Su JW, Tao JJ, Lang GJ, Wu XX, Wu WR, Qv TT, Xiang DR, Yi P, Shi D, Chen Y, Ren Y, Qiu YQ, Li LJ, Sheng J, Yang Y. Epidemiological, clinical and virological characteristics of 74 cases of coronavirus-infected disease 2019 (COVID-19) with gastrointestinal symptoms. Gut. 2020 Jun;69(6):1002-1009. doi: 10.1136/gutjnl-2020-320926. Epub 2020 Mar 24.
- 9. Mo P, Xing Y, Xiao Y, et al. Clinical characteristics of refractory COVID-19 pneumonia in Wuhan, China. [published online ahead of print, 2020 Mar 16]. Clin Infect Dis 2020:ciaa270. doi:10.1093/ 54. cid/ciaa270
- D'Amico F, Baumgart DC, Danese S, Peyrin-Biroulet L. Diarrhea During COVID-19 Infection: Pathogenesis, Epidemiology, Prevention, and Management. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1663-1672. doi: 10.1016/j.cgh.2020.04.001. Epub 2020 Apr 8.
- Tian S, Chang Z, Wang Y, Wu M, Zhang W, Zhou G, Zou X, Tian H, Xiao T, Xing J, Chen J, Han J, Ning K, Wu T. Clinical Characteristics and Reasons for Differences in Duration From Symptom Onset to Release From Quarantine Among Patients With COVID-19 in Liaocheng, China. Front Med (Lausanne). 2020 May 12;7:210. doi: 10.3389/fmed.2020.00210. eCollection 2020.
- Lu Y, Li Y, Deng W, Liu M, He Y, Huang L, Lv M, Li J, Du H. Symptomatic Infection is Associated with Prolonged Duration of Viral Shedding in Mild Coronavirus Disease 2019: A Retrospective Study of 110 Children in Wuhan. Pediatr Infect Dis J. 2020 Jul;39(7):e95-e99. doi: 10.1097/INF.0000000000002729.
- 13. World Health Organization. Clinical management of COVID-19: interim guidance. 2020, p.62.
- 14. National Egyptian Institutes of Health. Coronavirus Disease (COVID-19) Treatment Guidelines. 2020.
- World Medical Association Inc. Declaration of Helsinki. Ethical principles for medical research involving human subjects. J Indian Med Assoc. 2009 Jun;107(6):403-5. No abstract available.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections à coronavirus
- Infections à Coronaviridae
- Infections à Nidovirales
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Pneumonie virale
- Pneumonie
- Maladies pulmonaires
- Signes et symptômes digestifs
- COVID-19 [feminine]
- Diarrhée
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Inhibiteurs d'enzymes
- Agents antirhumatismaux
- Agents antiprotozoaires
- Agents antiparasitaires
- Antipaludéens
- Agents antibactériens
- Hydroxychloroquine
- Anticoagulants
Autres numéros d'identification d'étude
- 1004
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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