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AzTrials

Covid19NCT05046509

The Clinical Manifestations of the Severe Acute Respiratory Syndrome, Coronavirus 2( SARS-Cov-2 ); Not Only Pulmonary

An observational study of Covid19, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A prospective observational study to identify different extrapulmonary clinical manifestations of SARS-CoV-2 and its correlations with the disease severity grades. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
How many people
445 participants
Where
1 siteEgypt
Study dates
1 Apr 2021to 5 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Data will be collected from outpatients and inpatients files.

Who may be able to join

  • Patients have been confirmed diagnosed with Covid-19 disease by PCR
  • Patients aged 18 years and above

Who cannot join

  • Patients aged below 18 years old.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University Hospital

    Asyut, 741111

Other trials in Egypt

About this study

Official title: The Clinical Manifestations of SARS-Cov-2 Disease; Not Only Pulmonary

A prospective observational study to identify different extrapulmonary clinical manifestations of SARS-CoV-2 and its correlations with the disease severity grades.

Read the detailed description

The current research in this area was retrospective trials; this study is a prospective one. Investigators will perform the extensive recording of extrapulmonary manifestations in adult patients of SARS-CoV-2 and their correlations with the disease severity grades.

Type of the study: a prospective observational study

Study Setting:

Data will be collected from outpatients and inpatients files and a questionnaire.

Sample Size Calculation:

Depending on the average monthly (40-50 cases) and type of the study :

-Investigators will use Steven K. Thompson equation 13 to calculate the size from the next formula

Population size =(752) Sample size = (414) Level of confidence: ( 95%) Error proportion: (0.05) Probability :(20 %) Study power: (80 %)

Conditions
Covid19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05046509
Study groupRoleWhat they receive
COVID_Patients* Patients have been confirmed diagnosed with Covid-19 disease by PCR * Patients aged 18 years and above

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who has one or more of the following extrapulmonary clinical manifestations of SARS-CoV-2 .

    Cardiovascular :

    • Coronary Artery Disease
    • Infarction (type 2)
    • Myocarditis
    • Arrhythmia
    • Cardiogenic shock
    • Heart failure

    Gastrointestinal :

    • Anorexia
    • Diarrhea
    • Bleeding
    • Digestive symptoms
    • Abnormal liver tests

    Neurological :

    • Headache
    • Impaired consciousness
    • acute ischemic stroke
    • Ataxia
    • Dizziness
    • Seizure
    • Taste impairment
    • Smell impairment
    • Vision impairment
    • Viral encephalitis
    • Depression

    Endocrinal:

    • Hypoglycemia
    • Ketoacidosis
    • Hyperglycemia
    • Thyrotoxicosis
    • Secondary Adrenal Insufficiency

    Hematological:

    • Leukocytosis
    • Leukopenia
    • Thrombocytopenia
    • Anemia
    • Lymphocytosis
    • D-dimer
    • Lactate dehydrogenase
    • Ferritin

    Renal :

    • Albuminuria
    • Hematuria
    • Blood urea nitrogen
    • Acute kidney injury

    Ophthalmologic :

    -Conjunctivitis

    Dermatologic :

    • Papulovesicular rash
    • Rosacea
    • Dryness
    • Erythema
    • Urticaria
    • Maculopapular exanthem morbilliform

    Measured: one year

Secondary outcomes (1)

  1. The correlations between the number of participants who has extrapulmonary manifestations and the severity grade of SARS-CoV-2.

    These correlations between the number of participants who has one or more of extrapulmonary manifestations and the severity of SARS-CoV-2, will be measured.

    There are four severity grades of SARS-CoV-2 according to WHO classifications (mild, moderate, severe and critical)

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start1 Apr 2021
  3. Primary completion5 Jun 2022
  4. Study completion5 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
445 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05046509
Sponsor's protocol ID
17101489
Status last verified
Jun 2022
First submitted
3 Sep 2021
Last updated
8 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Xiao F, Tang M, Zheng X, Liu Y, Li X, Shan H. Evidence for Gastrointestinal Infection of SARS-CoV-2. Gastroenterology. 2020 May;158(6):1831-1833.e3. doi: 10.1053/j.gastro.2020.02.055. Epub 2020 Mar 3. No abstract available.

    PubMed 32142773

  • Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.

    PubMed 32275288

  • Zhu L, She ZG, Cheng X, Qin JJ, Zhang XJ, Cai J, Lei F, Wang H, Xie J, Wang W, Li H, Zhang P, Song X, Chen X, Xiang M, Zhang C, Bai L, Xiang D, Chen MM, Liu Y, Yan Y, Liu M, Mao W, Zou J, Liu L, Chen G, Luo P, Xiao B, Zhang C, Zhang Z, Lu Z, Wang J, Lu H, Xia X, Wang D, Liao X, Peng G, Ye P, Yang J, Yuan Y, Huang X, Guo J, Zhang BH, Li H. Association of Blood Glucose Control and Outcomes in Patients with COVID-19 and Pre-existing Type 2 Diabetes. Cell Metab. 2020 Jun 2;31(6):1068-1077.e3. doi: 10.1016/j.cmet.2020.04.021. Epub 2020 May 1.

    PubMed 32369736

  • Li J, Gong X, Wang Z, Chen R, Li T, Zeng D, Li M. Clinical features of familial clustering in patients infected with 2019 novel coronavirus in Wuhan, China. Virus Res. 2020 Sep;286:198043. doi: 10.1016/j.virusres.2020.198043. Epub 2020 Jun 2.

    PubMed 32502551

  • Perico L, Benigni A, Remuzzi G. Should COVID-19 Concern Nephrologists? Why and to What Extent? The Emerging Impasse of Angiotensin Blockade. Nephron. 2020;144(5):213-221. doi: 10.1159/000507305. Epub 2020 Mar 23.

    PubMed 32203970

  • Patel S, Rauf A, Khan H, Abu-Izneid T. Renin-angiotensin-aldosterone (RAAS): The ubiquitous system for homeostasis and pathologies. Biomed Pharmacother. 2017 Oct;94:317-325. doi: 10.1016/j.biopha.2017.07.091. Epub 2017 Jul 31.

    PubMed 28772209

  • Lanza K, Perez LG, Costa LB, Cordeiro TM, Palmeira VA, Ribeiro VT, Simoes E Silva AC. Covid-19: the renin-angiotensin system imbalance hypothesis. Clin Sci (Lond). 2020 Jun 12;134(11):1259-1264. doi: 10.1042/CS20200492.

    PubMed 32507883

  • Gembardt F, Sterner-Kock A, Imboden H, Spalteholz M, Reibitz F, Schultheiss HP, Siems WE, Walther T. Organ-specific distribution of ACE2 mRNA and correlating peptidase activity in rodents. Peptides. 2005 Jul;26(7):1270-7. doi: 10.1016/j.peptides.2005.01.009. Epub 2005 Feb 16.

    PubMed 15949646

  • Xu H, Zhong L, Deng J, Peng J, Dan H, Zeng X, Li T, Chen Q. High expression of ACE2 receptor of 2019-nCoV on the epithelial cells of oral mucosa. Int J Oral Sci. 2020 Feb 24;12(1):8. doi: 10.1038/s41368-020-0074-x.

    PubMed 32094336

  • Zou X, Chen K, Zou J, Han P, Hao J, Han Z. Single-cell RNA-seq data analysis on the receptor ACE2 expression reveals the potential risk of different human organs vulnerable to 2019-nCoV infection. Front Med. 2020 Apr;14(2):185-192. doi: 10.1007/s11684-020-0754-0. Epub 2020 Mar 12.

    PubMed 32170560

  • Martinez-Rojas MA, Vega-Vega O, Bobadilla NA. Is the kidney a target of SARS-CoV-2? Am J Physiol Renal Physiol. 2020 Jun 1;318(6):F1454-F1462. doi: 10.1152/ajprenal.00160.2020. Epub 2020 May 15.

    PubMed 32412303

  • Carsetti R, Quintarelli C, Quinti I, Piano Mortari E, Zumla A, Ippolito G, Locatelli F. The immune system of children: the key to understanding SARS-CoV-2 susceptibility? Lancet Child Adolesc Health. 2020 Jun;4(6):414-416. doi: 10.1016/S2352-4642(20)30135-8. Epub 2020 May 6. No abstract available.

    PubMed 32458804

  • [13] Steven K Thomson sampling 2012 third edition P 59-60

  • 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.

    PubMed 32171076

  • Hirsch JS, Ng JH, Ross DW, Sharma P, Shah HH, Barnett RL, Hazzan AD, Fishbane S, Jhaveri KD; Northwell COVID-19 Research Consortium; Northwell Nephrology COVID-19 Research Consortium. Acute kidney injury in patients hospitalized with COVID-19. Kidney Int. 2020 Jul;98(1):209-218. doi: 10.1016/j.kint.2020.05.006. Epub 2020 May 16.

    PubMed 32416116

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who has one or more of the following extrapulmonary clinical manifestations of SARS-CoV-2 . (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05046509, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.

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