| Trial registration number
|
NCT04715360 |
Full text link
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04715360
|
First author
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Karina Karina, MD, PhD
|
Contact
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
karina@hayandra.com
|
Registration date
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
2021-01-20
|
Recruitment status
Last imported at : Jan. 6, 2023, 8 p.m.
Source : ClinicalTrials.gov
|
Unknown
|
Study design
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
RCT
|
Allocation
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Randomized
|
Design
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Parallel
|
Masking
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Blind label
|
Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
|
single-center
|
Study aim
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Treatment
|
Inclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
- severe covid-19 patient in icu
|
Exclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
- ckd on hemodialysis, hiv positive, hepatitis, pregnant, destroyed lung, cancer
|
Number of arms
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
2
|
Funding
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Hayandra Peduli Foundation
|
Inclusion age min
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
18
|
Inclusion age max
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
65
|
Countries
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Indonesia
|
Type of patients
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Severe/critical disease at enrollment
|
Severity scale
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
7: Severe/critical disease at enrollment
|
Total sample size
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
30
|
primary outcome
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Effect of aaPRP on CRP level before and after intervention compared to control.;Effect of aaPRP on overall adverse event related to the treatment.;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.;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.
|
Notes
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
|
Phase 1/Phase 2
|
Arms
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "", "treatment_id": 144, "treatment_name": "Autologous activated platelet-rich plasma", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|