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| Name | Class |
|---|---|
| Koja Regional Public Hospital | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Only received standard medication (avigan) for severe COVID-19 management |
|
| PRP Group | Experimental | received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous activated platelet-rich plasma | Combination Product | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 days |
| 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. | 6 days |
| Effect of aaPRP on overall adverse event related to the treatment. | Patients with positive COVID19 who will improve after receiving aaPRP compared to control. | 6 days |
| 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. | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 days |
| Effect of aaPRP on duration of hospitality of patient compared to control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karina Karina, MD, PhD | Contact | 62.21.3909333 | karina@hayandra.com | |
| Imam Rosadi, M.Sc | Contact | 6285719593848 | imam.rosadi@hayandra.com |
| Name | Affiliation | Role |
|---|---|---|
| Louis Martin Christoffel, MD | Koja Regional Public Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koja Regional Public Hospital | Recruiting | Jakarta | DKI Jakarta | 14220 | Indonesia |
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| Avigan | Drug | Patient received avigan 2x1,600 mg for a day, followed by 2x600 mg for five consecutive days. |
|
Patients with positive COVID19 who will improve after receiving aaPRP compared to control. |
| 6 days |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| C462182 | favipiravir |
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