NCT04375124

Brief Summary

Novel Coronavirus is reported to cause COVID-19, recently. It's known that this virus uses ACE (angiotensin converting enzyme) 2 receptors to enter human cells and also blocks the activity of ACE 2. Upon these data the investigators hypothesize that, mortal hyper-inflammation state which is shown in COVID-19 cases, can be a result of angiotensin peptide (1-7) deficiency. Therefore, the aim of this study is to evaluate the possible effect of angiotensin peptide (1-7) supplementation on treatment of COVID-19 cases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable covid19

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 25, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

May 1, 2020

Last Update Submit

March 30, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • mortality

    mortality rates in two groups will be compared

    4 months

Study Arms (2)

non-peptide group

NO INTERVENTION

This group will receive routine treatment and care for COVID-19.

peptide group

ACTIVE COMPARATOR

This group will receive angiotensin peptide (1-7) supplementation in addition to routine treatment and care for COVID-19.

Biological: Biological/Vaccine: Angiotensin peptide (1-7) derived plasma

Interventions

Biological/Vaccine: Angiotensin peptide (1-7) derived plasmaBIOLOGICAL

angiotensin peptide (1-7) derived plasma will be given to COVID-19 positive participants

peptide group

Eligibility Criteria

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

You may qualify if:

  • accepted to participate with an informed consent
  • proven positive COVID-19

You may not qualify if:

  • declined to participate
  • genetic/chromosomal abnormalities
  • any kind of history of previous adverse events with transfusion
  • diagnosis of immune deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This group will receive angiotensin peptide (1-7) during their treatment at hospital.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 5, 2020

Study Start

April 25, 2020

Primary Completion

August 31, 2020

Study Completion

September 30, 2020

Last Updated

April 1, 2022

Record last verified: 2022-03

Locations

TU(1)