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

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ClinicalTrials.gov Identifier: NCT04715360
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
Koja Regional Public Hospital
Information provided by (Responsible Party):
Hayandra Peduli Foundation

Study Description
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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).

Condition or disease Intervention/treatment Phase
Covid19 Sars-CoV-2 Infection ARDS, Human Severe covid19 Combination Product: autologous activated platelet-rich plasma Drug: Avigan Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy
Actual Study Start Date : December 29, 2020
Estimated Primary Completion Date : November 29, 2021
Estimated Study Completion Date : December 27, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 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

Drug: Avigan
Patient received avigan 2x1,600 mg for a day, followed by 2x600 mg for five consecutive days.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • severe covid-19 patient in ICU

Exclusion Criteria:

  • CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715360


Contacts
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Contact: Karina Karina, MD, PhD 62.21.3909333 karina@hayandra.com
Contact: Imam Rosadi, M.Sc 6285719593848 imam.rosadi@hayandra.com

Locations
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Indonesia
Koja Regional Public Hospital Recruiting
Jakarta, DKI Jakarta, Indonesia, 14220
Contact: Louis Martin Christoffel, MD    6281340062037    louischristoffel200@gmail.com   
Sponsors and Collaborators
Hayandra Peduli Foundation
Koja Regional Public Hospital
Investigators
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Principal Investigator: Louis Martin Christoffel, MD Koja Regional Public Hospital
More Information
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Responsible Party: Hayandra Peduli Foundation
ClinicalTrials.gov Identifier: NCT04715360    
Other Study ID Numbers: 20-12-1526
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hayandra Peduli Foundation:
aaPRP
severe COVID-19
platelet-rich plasma
SARS-CoV-2
autologous
Additional relevant MeSH terms:
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COVID-19
Respiratory Distress Syndrome
Cytokine Release Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Respiration Disorders
Favipiravir
Antiviral Agents
Anti-Infective Agents