Back to resultsTreatment of Angiotensin Peptide (1-7) for COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Biological/Vaccine: Angiotensin peptide (1-7) derived plasma
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- accepted to participate with an informed consent
- proven positive COVID-19
Exclusion Criteria:
- declined to participate
- genetic/chromosomal abnormalities
- any kind of history of previous adverse events with transfusion
- diagnosis of immune deficiency
Sites / Locations
- Kanuni Sultan Suleyman Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
non-peptide group
peptide group
Arm Description
This group will receive routine treatment and care for COVID-19.
This group will receive angiotensin peptide (1-7) supplementation in addition to routine treatment and care for COVID-19.
Outcomes
Primary Outcome Measures
mortality
mortality rates in two groups will be compared
Secondary Outcome Measures
Full Information
NCT ID
NCT04375124
First Posted
May 1, 2020
Last Updated
March 30, 2022
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04375124
Brief Title
Treatment of Angiotensin Peptide (1-7) for COVID-19
Official Title
Evaluation of the Possible Role of Angiotensin Peptide (1-7) on Treatment of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 25, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
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 plasma derived angiotensin peptide (1-7) supplementation on treatment of COVID-19 cases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This group will receive angiotensin peptide (1-7) during their treatment at hospital.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-peptide group
Arm Type
No Intervention
Arm Description
This group will receive routine treatment and care for COVID-19.
Arm Title
peptide group
Arm Type
Active Comparator
Arm Description
This group will receive angiotensin peptide (1-7) supplementation in addition to routine treatment and care for COVID-19.
Intervention Type
Biological
Intervention Name(s)
Biological/Vaccine: Angiotensin peptide (1-7) derived plasma
Intervention Description
angiotensin peptide (1-7) derived plasma will be given to COVID-19 positive participants
Primary Outcome Measure Information:
Title
mortality
Description
mortality rates in two groups will be compared
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
accepted to participate with an informed consent
proven positive COVID-19
Exclusion Criteria:
declined to participate
genetic/chromosomal abnormalities
any kind of history of previous adverse events with transfusion
diagnosis of immune deficiency
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment of Angiotensin Peptide (1-7) for COVID-19
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