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ARB, ACEi, DRi in COVID-19 (BIRCOV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04364984
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Medical Practice Prof D. Ivanov

Brief Summary:
It is supposed to monitor hypertensive patients who are infected or have clinical manifestations of COVID-19 for 1 month after the onset of the disease. Three groups will be considered: 1. receiving ACE inhibitors 2. receiving ARBs 3. receiving DIR.

Condition or disease Intervention/treatment
Hypertension COVID-19 Drug: Angiotensin converting enzyme inhibitor

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: ARB, ACEi, DRi Usage in COVID-19
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ARB group
Hypertensive patients with COVID-19 who received ARBs
ACEi group
Hypertensive patients with COVID-19 who received ACEis
Drug: Angiotensin converting enzyme inhibitor
routine drug intake

DRi
Hypertensive patients with COVID-19 who received DRis



Primary Outcome Measures :
  1. BP (hypertensive efficacy) [ Time Frame: 4 weeks ]
    BP one week before COVID-19 infection and 3 weeks follow-up after COVID-19 onset


Secondary Outcome Measures :
  1. COVID-19 course [ Time Frame: 3 weeks ]
    features of disease course: number of patients and duration of fever (above 37.2C), duration of cough (days), duration of throat pain (days), headache (days), nausea or vomiting (days), diarrhea (days), myalgia or arthalgia (days), and numder of patients who need hospital and intensive care unit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with proved COVID-19 and preliminary documented hypertension 1-2 stage on RASi at the onset and COVID-19 course during 3 weeks
Criteria

Inclusion Criteria:

  • Hypertensive person, stage 1-2

Exclusion Criteria:

  • Hypertensive subjects, stage 3, HF (NYHA) 3-4

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04364984


Locations
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Ukraine
Medical Practice Prof D.Ivanov Recruiting
Kiev, Please Select, Ukraine, 01014
Contact: Dmytro Ivanov, MD, Prof    0504448788 ext +38    ivanovdd@i.kiev.ua   
Contact: Mariia Ivanova, MD, PhD    0971094024 ext +38    mesangium88@mail.com   
Sponsors and Collaborators
Medical Practice Prof D. Ivanov
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Responsible Party: Medical Practice Prof D. Ivanov
ClinicalTrials.gov Identifier: NCT04364984    
Other Study ID Numbers: COVID20
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical Practice Prof D. Ivanov:
ACEi, ARB, DRI
Clinical features
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors