NCT04715360

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started Dec 2020

Typical duration for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 29, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

January 15, 2021

Last Update Submit

January 17, 2021

Conditions

Covid19Sars-CoV-2 InfectionARDS, HumanSevere covid19

Keywords

aaPRPsevere COVID-19platelet-rich plasmaSARS-CoV-2autologous

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Effect of aaPRP on Thorax X-ray image pre and post intervention between control and aaPRP-treated group

    6 days

  • Effect of aaPRP on duration of hospitality of patient compared to control

    6 days

Study Arms (2)

Control

OTHER

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

Drug: Avigan

PRP Group

EXPERIMENTAL

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

Combination Product: autologous activated platelet-rich plasmaDrug: Avigan

Interventions

autologous activated platelet-rich plasmaCOMBINATION_PRODUCT

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

PRP Group
AviganDRUG

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

ControlPRP Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe covid-19 patient in ICU

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koja Regional Public Hospital

Jakarta, DKI Jakarta, 14220, Indonesia

RECRUITING

MeSH Terms

Conditions

COVID-19Respiratory Distress Syndrome

Interventions

favipiravir

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Louis Martin Christoffel, MD

    Koja Regional Public Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina Karina, MD, PhD

CONTACT

62.21.3909333karina@hayandra.com

Imam Rosadi, M.Sc

CONTACT

6285719593848imam.rosadi@hayandra.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 20, 2021

Study Start

December 29, 2020

Primary Completion

November 29, 2021

Study Completion

December 27, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

ID(1)