NCT04364984

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2021

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 18, 2022

Completed
Last Updated

March 21, 2023

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

April 23, 2020

Results QC Date

August 27, 2021

Last Update Submit

March 18, 2023

Conditions

Keywords

ACEi, ARB, DRIClinical featuresCKD

Outcome Measures

Primary Outcomes (1)

  • Level of BP in mm Hg

    BP in patients one week before COVID-19 infection and 2, 4, 12, 24 weeks follow-up after COVID-19 onset

    estimated at 2, 4, 12, 24 weeks after the start of COVID-19; data for 24 weeks are reported

Secondary Outcomes (5)

  • Number of Patients With Fever Above 37.2 on COVID-19 Course

    estimated at 2, 4, 12 weeks after the COVID-19 onset

  • Number of Patients With Cough in COVID-19 Course

    on 2,4 and 12 week from COVID-19 onset

  • Number of Patients With Throat Pain in COVID-19 Course

    estimated at 2, 4, 12 weeks after the COVID-19 onset

  • Number of Patients With Diarrhea Inf COVID-19 Course

    estimated at 2, 4, 12 weeks after the COVID-19 onset

  • Number of Patients Who Need to Apply to Hospital in COVID-19 Course

    estimated at 2, 4, 12 weeks after the COVID-19 onset

Study Arms (3)

ARB group

Hypertensive patients with COVID-19 who received ARBs

Drug: Angiotensin Receptor Blockers

ACEi group

Hypertensive patients with COVID-19 who received ACEis

Drug: Angiotensin converting enzyme inhibitor

DRi group

Hypertensive patients with COVID-19 who received direct renin inhibitor (DRis)

Drug: Direct renin inhibitor

Interventions

routine drug intake

Also known as: no other drug as RAS inhibitor
ACEi group

routine drug intake

Also known as: no other drug as RAS inhibitor
ARB group

routine drug intake

Also known as: no other drug as RAS inhibitor
DRi group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Hypertensive person, stage 1-2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Practice Prof D.Ivanov

Kiev, Please Select, 01014, Ukraine

Location

MeSH Terms

Conditions

HypertensionCOVID-19

Interventions

Angiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsRenin Inhibitors

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Protease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Prof Dmytro Ivanov
Organization
Medical Practice Prof D.Ivanov

Study Officials

  • Iryna Zavalna, MD

    Nephrology clinic

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 28, 2020

Study Start

April 1, 2020

Primary Completion

July 24, 2021

Study Completion

August 1, 2021

Last Updated

March 21, 2023

Results First Posted

February 18, 2022

Record last verified: 2021-08

Locations