ARDS, Human, Covid19, Sars-CoV-2 Infection, Severe covid19
Conditions
Keywords
aaPRP, severe COVID-19, platelet-rich plasma, SARS-CoV-2, autologous
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.
Interventions
DRUGAvigan
Patient received avigan 2x1,600 mg for a day, followed by 2x600 mg for five consecutive days.
COMBINATION_PRODUCTautologous activated platelet-rich plasma
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
Sponsors
Koja Regional Public Hospital
Hayandra Peduli Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* severe covid-19 patient in ICU
Exclusion criteria
* CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | 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. | 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. | 6 days | Patients with positive COVID19 who will improve after receiving aaPRP compared to control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of aaPRP on Thorax X-ray image pre and post intervention between control and aaPRP-treated group | 6 days | 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 | 6 days | Patients with positive COVID19 who will improve after receiving aaPRP compared to control. |
Countries
Indonesia
Contacts
Primary ContactKarina Karina, MD, PhD
Backup ContactImam Rosadi, M.Sc
Outcome results
None listed