Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy

Phase 1

• Conditions: Covid19; Sars-CoV-2 Infection; ARDS, Human; Severe covid19
• Interventions: Drug: Avigan; Combination Product: autologous activated platelet-rich plasma

• Registration Number: NCT04715360
• Lead Sponsor: Hayandra Peduli Foundation

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 Timeline

• Study Start: 2020-12-29
• Status Verified: 2021-01
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-17
• Last Update Submitted: 2021-01-17
• Study First Posted: 2021-01-20
• Last Update Posted: 2021-01-20
• Primary Completion: 2021-11-29
• Study Completion: 2021-12-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• severe covid-19 patient in ICU

Exclusion Criteria

• CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Avigan	Only received standard medication (avigan) for severe COVID-19 management
PRP Group	autologous activated platelet-rich plasma	received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion
PRP Group	Avigan	received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion

Primary Outcome Measures

Name	Time	Method
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.
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.
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 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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Koja Regional Public Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia