COVID-19 Disease Duration and GIT Manifestations. A New Disease Severity Classification. An Egyptian Experience

Covid19 Clinical Trial

Official title:

Corona Virus (COVID-19) Disease Duration and Gastrointestinal Tract (GIT) Manifestations; Can be New Disease Severity Classification. A Pilot Egyptian Single National Center Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04554979
• Other study ID #: 1004
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: July 15, 2020

Study information

• Verified date: September 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present study conducted to correlate symptoms not only constitutional and respiratory, but GIT as a principle presentation, with laboratory markers and COVID-19 severe acute respiratory syndrome (SARS-COV2) disease outcomes, as the duration of symptoms varies substantially between patients; the investigators undertook this study to determine the optimal time to predict COVID-19 outcomes based on real-time experience.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Diarrhea

Intervention

Drug:
• Hydroxychloroquine Pill
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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (15)

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.

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.

8. Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. [published online ahead of print, 2020 Feb 7]. JAMA 2020;e201585. doi:10.1001/jama.2020.1585

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. — View Citation

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. — View Citation

Hoehl S, Rabenau H, Berger A, Kortenbusch M, Cinatl J, Bojkova D, Behrens P, Böddinghaus B, Götsch 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. — View Citation

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. — View Citation

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. — View Citation

Mo P, Xing Y, Xiao Y, Deng L, Zhao Q, Wang H, Xiong Y, Cheng Z, Gao S, Liang K, Luo M, Chen T, Song S, Ma Z, Chen X, Zheng R, Cao Q, Wang F, Zhang Y. Clinical characteristics of refractory COVID-19 pneumonia in Wuhan, China. Clin Infect Dis. 2020 Mar 16. pii: ciaa270. doi: 10.1093/cid/ciaa270. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 disease spectrum and duration	The investigators tried to correlate disease severity with disease duration	july 2020 to june 2020
Primary	GIT manifestations among COVID-19 patients	spectrum of GIT manifestations in COVID-19 patients was investigated	july 2020 to june 2020
Secondary	Non-communicable disease and COVID-19	The link between non-communicable disease (including diabetes, hypertension and Hypercholesterolemia) severity and COVID-19 prognosis	july 2020 to june 2020
Secondary	Seasonal change and COVID-19	the investigators studied the Impact of weather climate on COVID-19 presentations (higher incidence of diarrhea in COVID-19 patients in summer) and outcomes	july 2020 to june 2020
Secondary	Possible region specific classification for COVID-19 disease	The investigators tried to find new Egyptian classification fro COVID-19 disease severity	july 2020 to june 2020