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

Hayandra Peduli Foundation

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Severe covid19; Covid19; Sars-CoV-2 Infection; ARDS, Human

Treatments: Combination Product: autologous activated platelet-rich plasma; Drug: Avigan

Study type: Interventional

Funder types: Other

Identifiers

NCT04715360

20-12-1526

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• severe covid-19 patient in ICU

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Control

Other group

Description:

Only received standard medication (avigan) for severe COVID-19 management

Treatment:

Drug: Avigan

PRP Group

Experimental group

Description:

received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion

Treatment:

Combination Product: autologous activated platelet-rich plasma

Drug: Avigan