Back to resultsManagement of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy
Primary Purpose
Covid19, Sars-CoV-2 Infection, ARDS, Human
Status
Unknown status
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
autologous activated platelet-rich plasma
Avigan
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring aaPRP, severe COVID-19, platelet-rich plasma, SARS-CoV-2, autologous
Eligibility Criteria
Inclusion Criteria:
- severe covid-19 patient in ICU
Exclusion Criteria:
- CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer
Sites / Locations
- Koja Regional Public HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control
PRP Group
Arm Description
Only received standard medication (avigan) for severe COVID-19 management
received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion
Outcomes
Primary Outcome Measures
Effect of aaPRP on pro-inflammatory cytokines plasma level (IL-6, IL-1B, TNFa, IFN gamma, MCP-1) before and after intervention compared to control.
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
to evaluate the change of Effect of aaPRP on anti-inflammatory cytokines plasma level (IL-1RA, IL-4, IL-10) before and after intervention compared to control.
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Effect of aaPRP on overall adverse event related to the treatment.
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Effect of aaPRP on CRP level before and after intervention compared to control.
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Secondary Outcome Measures
Effect of aaPRP on Thorax X-ray image pre and post intervention between control and aaPRP-treated group
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Effect of aaPRP on duration of hospitality of patient compared to control
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Full Information
NCT ID
NCT04715360
First Posted
January 15, 2021
Last Updated
January 17, 2021
Sponsor
Hayandra Peduli Foundation
Collaborators
Koja Regional Public Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04715360
Brief Title
Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy
Official Title
Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 29, 2020 (Actual)
Primary Completion Date
November 29, 2021 (Anticipated)
Study Completion Date
December 27, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hayandra Peduli Foundation
Collaborators
Koja Regional Public 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
The positive cases of coronavirus disease-2019 (COVID-19) in Indonesia has been increasing rapidly since the first case found in March 2020 to date. Coronavirus 2 (SARS-CoV-2) virus disrupts human normal immune system resulting in uncontrolled inflammatory response. Based on our research and experience in doing cell therapy for 9 years, activated platelet-rich plasma (PRP) produces anti-inflammatory effects in inflammatory condition that is beneficial for tissue regeneration. In this study, we aimed to evaluate the potential of autologous activated platelet-rich plasma (aaPRP) and the outcomes for treating severe Coronavirus Disease-2019 (COVID-19) patients in Intensive Care Unit (ICU).
Detailed Description
PRP decreases IL-1β, IL-6, IL-8, and TNFα inflammatory genes expression while also reduces IL-1β and TNFα inflammatory cytokines production. PRP has also been showed to contain interleukin 1 receptor antagonist (IL-1RA), an anti-inflammatory cytokines that suppress IL-6 secretion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Sars-CoV-2 Infection, ARDS, Human, Severe covid19
Keywords
aaPRP, severe COVID-19, platelet-rich plasma, SARS-CoV-2, autologous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
Only received standard medication (avigan) for severe COVID-19 management
Arm Title
PRP Group
Arm Type
Experimental
Arm Description
received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion
Intervention Type
Combination Product
Intervention Name(s)
autologous activated platelet-rich plasma
Intervention Description
Patient received standard medication for COVID-19 management and autologous activated platelet-rich plasma on day 1, 3 and 5 while patient in ICU. On day 0, 4 and 6, hematology analysis, multicytokines measurement and thorax X-ray were done to each patient
Intervention Type
Drug
Intervention Name(s)
Avigan
Intervention Description
Patient received avigan 2x1,600 mg for a day, followed by 2x600 mg for five consecutive days.
Primary Outcome Measure Information:
Title
Effect of aaPRP on pro-inflammatory cytokines plasma level (IL-6, IL-1B, TNFa, IFN gamma, MCP-1) before and after intervention compared to control.
Description
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Time Frame
6 days
Title
to evaluate the change of Effect of aaPRP on anti-inflammatory cytokines plasma level (IL-1RA, IL-4, IL-10) before and after intervention compared to control.
Description
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Time Frame
6 days
Title
Effect of aaPRP on overall adverse event related to the treatment.
Description
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Time Frame
6 days
Title
Effect of aaPRP on CRP level before and after intervention compared to control.
Description
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Effect of aaPRP on Thorax X-ray image pre and post intervention between control and aaPRP-treated group
Description
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Time Frame
6 days
Title
Effect of aaPRP on duration of hospitality of patient compared to control
Description
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
severe covid-19 patient in ICU
Exclusion Criteria:
CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karina Karina, MD, PhD
Phone
62.21.3909333
Email
karina@hayandra.com
First Name & Middle Initial & Last Name or Official Title & Degree
Imam Rosadi, M.Sc
Phone
6285719593848
Email
imam.rosadi@hayandra.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Martin Christoffel, MD
Organizational Affiliation
Koja Regional Public Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Koja Regional Public Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
14220
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Martin Christoffel, MD
Phone
6281340062037
Email
louischristoffel200@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy
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