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Treatment of Angiotensin Peptide (1-7) for COVID-19

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: NCT04375124
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Hasan Onal, Kanuni Sultan Suleyman Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Biological/Vaccine: Angiotensin peptide (1-7) derived plasma Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This group will receive angiotensin peptide (1-7) during their treatment at hospital.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Possible Role of Angiotensin Peptide (1-7) on Treatment of COVID-19
Actual Study Start Date : April 25, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
No Intervention: non-peptide group
This group will receive routine treatment and care for COVID-19.
Active Comparator: peptide group
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
angiotensin peptide (1-7) derived plasma will be given to COVID-19 positive participants




Primary Outcome Measures :
  1. mortality [ Time Frame: 4 months ]
    mortality rates in two groups will be compared



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04375124


Contacts
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Contact: Hasan Onal +905325092988 hasanonal@hotmail.com
Contact: Seda Yilmaz Semerci +905337180683 sedayilmazsemerci@gmail.com

Locations
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Turkey
Kanuni Sultan Suleyman Training and Research Hospital Recruiting
Istanbul, Turkey, 34303
Contact: Hasan Onal    +905325092988    hasanonal@hotmail.com   
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
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Responsible Party: Hasan Onal, Professor, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04375124    
Other Study ID Numbers: KSSEAH--0059
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No