NCT05398731

Brief Summary

  1. 1.To determine the risk of COVID -19 in patients who use ACEI and ARBS
  2. 2.To determine the Effect of ACEI and ARBS on COVID -19 infection .
  3. 3.To determine the Severity of COVID -19 in patients who use ACEI and ARBS .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 7, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

May 19, 2022

Last Update Submit

June 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • determine the risk of COVID -19 in patients who use ACEI and ARBS

    determine the risk of COVID -19 in patients who use ACEI and ARBS

    from begining of Covid_19 pandemic up till now

Secondary Outcomes (1)

  • determine the morbidity and Severity of COVID -19 in patients who use ACEI and ARBS

    from begining of Covid_19 pandemic up till now

Study Arms (4)

patients received ACEI

patient who use ACEI ( Duration, type of response, and the time period between the begining of and the emergence of symptoms of COVID-19)

Other: Covid_19

patients received ARBs

patient who use ARBs ( Duration, type of response, and the time period between the begining of and the emergence of symptoms of COVID-19)

Other: Covid_19

other antihypertensive drugs

patient who use other antihypertensive drugs(for example ca channel blockers and Beta blockers) ( Duration, type of response, and the time period between the begining of and the emergence of symptoms of COVID-19)

Other: Covid_19

non hypertensive group

Non hypertensive persons with matched age and sex

Other: Covid_19

Interventions

Duration, type of response, and the time period between the begining of drug and the emergence of symptoms of COVID-19

Also known as: ARBs, ca channel blockers, Beta blockers
non hypertensive groupother antihypertensive drugspatients received ACEIpatients received ARBs

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

questionnaire with 5 Domain: 1. Personal and demographic data, socioeconomic status. and other co comorbid diseases. 2. Included patients(groups) 3. Adherence of the patients to precautions against SARS-COV2. 4. SARS-CoV-2 infection: 5. Post COVID- 19 symptoms. 6. any investigation with the pt

You may qualify if:

  • Age \>18 years old.
  • patients who use ACEI
  • patients who use ARBs
  • patients who use other antihypertensive drugs(for example ca channel blockers or Beta blockers)
  • Non hypertensive persons with matched age and sex

You may not qualify if:

  • \< 18 years old.
  • Pregnant or breast-feeding patients.
  • Patients with autoimmune disease.
  • Patients with multi organ failure, active cancer, renal insufficiency or chronic kidney disease.
  • Patients received immunosuppressive drugs.
  • Immune compromised patients.
  • Patients with obstructive lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Fehr AR, Perlman S. Coronaviruses: an overview of their replication and pathogenesis. Methods Mol Biol. 2015;1282:1-23. doi: 10.1007/978-1-4939-2438-7_1.

    PMID: 25720466BACKGROUND
  • Wang H, Yang P, Liu K, Guo F, Zhang Y, Zhang G, Jiang C. SARS coronavirus entry into host cells through a novel clathrin- and caveolae-independent endocytic pathway. Cell Res. 2008 Feb;18(2):290-301. doi: 10.1038/cr.2008.15.

    PMID: 18227861BACKGROUND
  • Byrd, James Brian; Ram, C. Venkata S.; Lerma, Edgar V. 2019

    BACKGROUND
  • Peng Zhang, Lihua Zhu, Jingjing Cai, Fang Lei, Juan-Juan Qin, Jing Xie, Ye-Mao Liu, Yan-Ci Zhao, Xuewei Huang, Lijin Lin, Meng Xia, Ming-Ming Chen, Xu Cheng, Xiao Zhang, Deliang Guo, Yuanyuan Peng, Yan-Xiao Ji, Jing Chen, Zhi-Gang She, Yibin Wang, Qingbo Xu, Renfu Tan, Haitao Wang, Jun Lin, Pengcheng Luo, Shouzhi Fu, Hongbin Cai, Ping Ye, Bing Xiao, Weiming Mao, Liming Liu, Youqin Yan, Mingyu Liu, Manhua Chen, Xiao-Jing Zhang, Xinghuan Wang, Rhian M. Touyz, Jiahong Xia, Bing-Hong Zhang, Xiaodong Huang, Yufeng Yuan, Rohit Loomba, Peter P. Liu, and Hongliang Li.April 2020

    BACKGROUND
  • Bombardini T, Picano E. Angiotensin-Converting Enzyme 2 as the Molecular Bridge Between Epidemiologic and Clinical Features of COVID-19. Can J Cardiol. 2020 May;36(5):784.e1-784.e2. doi: 10.1016/j.cjca.2020.03.026. Epub 2020 Mar 29. No abstract available.

    PMID: 32299780BACKGROUND
  • Reynolds HR, Adhikari S, Pulgarin C, Troxel AB, Iturrate E, Johnson SB, Hausvater A, Newman JD, Berger JS, Bangalore S, Katz SD, Fishman GI, Kunichoff D, Chen Y, Ogedegbe G, Hochman JS. Renin-Angiotensin-Aldosterone System Inhibitors and Risk of Covid-19. N Engl J Med. 2020 Jun 18;382(25):2441-2448. doi: 10.1056/NEJMoa2008975. Epub 2020 May 1.

    PMID: 32356628BACKGROUND

MeSH Terms

Interventions

Adrenergic beta-Antagonists

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Officials

  • Hanan M Adawy Nafeh, PhD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanan M Adawy Nafeh, professor

CONTACT

Rasha M Shehata, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

May 19, 2022

First Posted

June 1, 2022

Study Start

June 1, 2022

Primary Completion

March 1, 2023

Study Completion

May 1, 2023

Last Updated

June 7, 2022

Record last verified: 2022-05