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

January 17, 2021 updated by: Hayandra Peduli Foundation
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 14220
        • Recruiting
        • Koja Regional Public Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • severe covid-19 patient in ICU

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Only received standard medication (avigan) for severe COVID-19 management
Drug: Avigan
Patient received avigan 2x1,600 mg for a day, followed by 2x600 mg for five consecutive days.
Experimental: PRP Group
received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion
Drug: Avigan
Patient received avigan 2x1,600 mg for a day, followed by 2x600 mg for five consecutive days.
Combination product: autologous 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 6 days
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.
Time Frame: 6 days
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.
Time Frame: 6 days
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.
Time Frame: 6 days
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of aaPRP on Thorax X-ray image pre and post intervention between control and aaPRP-treated group
Time Frame: 6 days
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
Time Frame: 6 days
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hayandra Peduli Foundation

Collaborators

Koja Regional Public Hospital

Investigators

  • Principal Investigator: Louis Martin Christoffel, MD, Koja Regional Public Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2020

Primary Completion (Anticipated)

November 29, 2021

Study Completion (Anticipated)

December 27, 2021

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 17, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 17, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-12-1526

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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