Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •severe covid-19 patient in ICU
Exclusion Criteria
- •CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer
Arms & Interventions
Control
Only received standard medication (avigan) for severe COVID-19 management
Intervention: Avigan (Drug)
PRP Group
received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion
Intervention: autologous activated platelet-rich plasma (Combination Product)
PRP Group
received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion
Intervention: Avigan (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: 6 days
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Effect of aaPRP on overall adverse event related to the treatment.
Time Frame: 6 days
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.
Time Frame: 6 days
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.
Time Frame: 6 days
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Secondary Outcomes
- Effect of aaPRP on duration of hospitality of patient compared to control(6 days)
- Effect of aaPRP on Thorax X-ray image pre and post intervention between control and aaPRP-treated group(6 days)