Covid19Phase 1/2NCT04715360
Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy
A Phase 1/2 study testing autologous activated platelet-rich plasma and Avigan in people with Covid19 and Sars-CoV-2 Infection, run by Hayandra Peduli Foundation at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19, Sars-CoV-2 Infection, ARDS, Human
- What is being tested?
- autologous activated platelet-rich plasma and Avigan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 29 Dec 2020to 27 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe covid-19 patient in ICU
Who cannot join
- CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Koja Regional Public Hospital
Jakarta, DKI Jakarta, 14220
Louis Martin Christoffel, MD, 6281340062037, louischristoffel200@gmail.com
About this study
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).
Read the 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.
- Conditions
- Covid19, Sars-CoV-2 Infection, ARDS, Human, Severe covid19
- Being tested
- autologous activated platelet-rich plasma, Avigan
- Keywords
- aaPRP, severe COVID-19, platelet-rich plasma, SARS-CoV-2, autologous
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
AviganDrug
Patient received avigan 2x1,600 mg for a day, followed by 2x600 mg for five consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Only received standard medication (avigan) for severe COVID-19 management Receives: Drug: Avigan |
| PRP Group | Experimental | received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion Receives: Combination Product: autologous activated platelet-rich plasma; Drug: Avigan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 days
Secondary outcomes (2)
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.
Measured: 6 days
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.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start29 Dec 2020
- Primary completion29 Nov 2021 (estimated)
- Study completion27 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayandra Peduli Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Koja Regional Public Hospital
- Responsible party
- Sponsor
- Investigators
- Louis Martin Christoffel, MD, Principal investigator, Koja Regional Public Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715360
- Sponsor's protocol ID
- 20-12-1526
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy
- ClinicalTrials.gov ID
- NCT04715360
- Acronym / sponsor ID
- 20-12-1526
- Conditions
- Covid19, Sars-CoV-2 Infection, ARDS, Human, Severe covid19
- Keywords
- aaPRP, severe COVID-19, platelet-rich plasma, SARS-CoV-2, autologous
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hayandra Peduli FoundationUniversity, hospital or other
- Collaborators
- Koja Regional Public Hospital
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 29 Nov 2021 (estimated)
- Study completion
- 27 Dec 2021 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Drug: AviganOnly received standard medication (avigan) for severe COVID-19 management |
| PRP Group | Experimental | Combination Product: autologous activated platelet-rich plasma, Drug: Aviganreceived standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe covid-19 patient in ICU
Key exclusion criteria (1 listed)
- CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous activated platelet-rich plasmaPatient 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 | Combination product | PRP Group |
| AviganPatient received avigan 2x1,600 mg for a day, followed by 2x600 mg for five consecutive days. | Drug | Control, PRP Group |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Effect of aaPRP on Thorax X-ray image pre and post intervention between control and aaPRP-treated group
Time frame: 6 days
Effect of aaPRP on duration of hospitality of patient compared to control
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Martin Christoffel, MD principal investigator
Koja Regional Public Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing autologous activated platelet-rich plasma and Avigan in people with Covid19 and Sars-CoV-2 Infection, run by Hayandra Peduli Foundation at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karina Karina, MD, PhD (62.21.3909333, karina@hayandra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.