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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04715360
• Other study ID #: 20-12-1526
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 29, 2020
• Est. completion date: December 27, 2021

Study information

• Verified date: January 2021
• Source: Hayandra Peduli Foundation
• Contact: Karina Karina, MD, PhD
• Phone: 62.21.3909333
• Email: karina[@]hayandra.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 27, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• severe covid-19 patient in ICU

Exclusion Criteria:

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

Related Conditions & MeSH terms

• ARDS, Human
• Covid19
• Respiratory Distress Syndrome, Adult
• Sars-CoV-2 Infection
• Severe covid19

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Koja Regional Public Hospital	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Hayandra Peduli Foundation	Koja Regional Public Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Effect of aaPRP on duration of hospitality of patient compared to control	Patients with positive COVID19 who will improve after receiving aaPRP compared to control.	6 days