SARS-CoV-2 InfectionPhase 2/3TPCCNCT04747158
COVID-19 Convalescent Plasma Therapy
A Phase 2/3 study testing Convalescent plasma in people with SARS-CoV-2 Infection and COVID-19 Infection, run by Universidad Nacional de Asunción at 1 site in Paraguay.
Trial summary
This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 [COVID-19] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, COVID-19 Infection
- What is being tested?
- Convalescent plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteParaguay
- Study dates
- 10 Aug 2020to 10 Jan 2021
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 Years and older
- Presence of risk factors of severe COVID 19 diagnosed by quantitative polymerase chain reaction by reverse transcription (RT-qPCR)
- Patients with no more than 15 days from the onset of symptoms
- Signed informed consent
Who cannot join
- Severely ill patients admitted directly to the ICU.
- Need for mechanical ventilation at the time of hospital admission, regardless of the time of clinical evolution.
- History of previous hypersensitivity to plasma transfusions.
- History of immunoglobulin A (IgA) deficiency
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Paraguay1 site
Facultad de Ciencias Médicas - Universidad Nacional de Asunción
Asunción, 111421
About this study
This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 [COVID-19] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start).
- Conditions
- SARS-CoV-2 Infection, COVID-19 Infection
- Being tested
- Convalescent plasma
- Keywords
- SARS-CoV-2 infection, Convalescent plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent plasmaBiological
COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| Convalescent plasma | Experimental | COVID-19 convalescent plasma Receives: Biological: Convalescent plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (30-day mortality)
To evaluate the effectiveness of convalescent plasma therapy COVID-19, to decrease mortality in hospitalized patients with COVID-19 and who present some risk factor for clinical deterioration.
Measured: 30 days
Secondary outcomes (8)
Median length of hospital stay
To describe the median length of hospital stay in days
Measured: 30 days
Change in clinical status
To asses the changes of disease severity, according to the COVID-19 disease severity from the World Health Organization (WHO) Interim guidance.
Measured: 0, 3, 7 and 14 days
Change in inflammatory marker: ferritin
To measure changes in ferritin (μg/L) at 0, 7 and 14 days
Measured: 0, 7 and 14 days
Change in inflammatory marker: D dimer
To measure changes in D dimer (mg/L) at 0, 7 and 14 days
Measured: 0, 7 and 14 days
Change in inflammatory marker: leukocytes
To measure leukocytes (/mm3) changes at 0, 7 and 14 days
Measured: 0, 7 and 14 days
Serum Antibody Titers
To measure immunoglobulin G (IgG) SARS-CoV 2 titles
Measured: 0, 3 and 7 days
Transfer to ICU
To asses the frequency of patients admitted to ICU
Measured: 30 days
Transfusion related events
To asses the frequency of adverse events to convalescent plasma
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start10 Aug 2020
- Primary completion10 Dec 2020
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Asunción
- Sponsor type
- University, hospital or other
- Collaborators
- Consejo Nacional de Ciencias y Tecnología, Paraguay, Ministerio de Salud Pública y Bienestar Social, Paraguay, Centro de información y recursos para el desarrollo, Paraguay
- Responsible party
- Sponsor
- Investigators
- Angelica Jimenez de Samudio, MD,MSc, Principal investigator, Facultad de Ciencias Médicas - Universidad Nacional de Asunción
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747158
- Sponsor's protocol ID
- PINV20-388
- Acronym
- TPCC
- Status last verified
- Feb 2021
- First submitted
- 27 Jan 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will publish the results to compare data with other studies with COVID-19 convalescent plasma patients
Publications
Yoon HA, Bartash R, Gendlina I, Rivera J, Nakouzi A, Bortz RH 3rd, Wirchnianski AS, Paroder M, Fehn K, Serrano-Rahman L, Babb R, Sarwar UN, Haslwanter D, Laudermilch E, Florez C, Dieterle ME, Jangra RK, Fels JM, Tong K, Mariano MC, Vergnolle O, Georgiev GI, Herrera NG, Malonis RJ, Quiroz JA, Morano NC, Krause GJ, Sweeney JM, Cowman K, Allen S, Annam J, Applebaum A, Barboto D, Khokhar A, Lally BJ, Lee A, Lee M, Malaviya A, Sample R, Yang XA, Li Y, Ruiz R, Thota R, Barnhill J, Goldstein DY, Uehlinger J, Garforth SJ, Almo SC, Lai JR, Gil MR, Fox AS, Chandran K, Wang T, Daily JP, Pirofski LA. Treatment of Severe COVID-19 with Convalescent Plasma in the Bronx, NYC. medRxiv [Preprint]. 2020 Dec 4:2020.12.02.20242909. doi: 10.1101/2020.12.02.20242909.
PubMed 33300012Joyner MJ, Bruno KA, Klassen SA, Kunze KL, Johnson PW, Lesser ER, Wiggins CC, Senefeld JW, Klompas AM, Hodge DO, Shepherd JRA, Rea RF, Whelan ER, Clayburn AJ, Spiegel MR, Baker SE, Larson KF, Ripoll JG, Andersen KJ, Buras MR, Vogt MNP, Herasevich V, Dennis JJ, Regimbal RJ, Bauer PR, Blair JE, van Buskirk CM, Winters JL, Stubbs JR, van Helmond N, Butterfield BP, Sexton MA, Diaz Soto JC, Paneth NS, Verdun NC, Marks P, Casadevall A, Fairweather D, Carter RE, Wright RS. Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients. Mayo Clin Proc. 2020 Sep;95(9):1888-1897. doi: 10.1016/j.mayocp.2020.06.028. Epub 2020 Jul 19.
PubMed 32861333Clinical Management of COVID-19 - Interim guidance 27 May 2020. WHO reference number: WHO/2019-nCoV/clinical/2020.5
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Convalescent Plasma Therapy
- ClinicalTrials.gov ID
- NCT04747158
- Acronym / sponsor ID
- TPCC / PINV20-388
- Conditions
- SARS-CoV-2 Infection, COVID-19 Infection
- Keywords
- SARS-CoV-2 infection, Convalescent plasma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Universidad Nacional de AsunciónUniversity, hospital or other
- Collaborators
- Consejo Nacional de Ciencias y Tecnología, Paraguay, Ministerio de Salud Pública y Bienestar Social, Paraguay, Centro de información y recursos para el desarrollo, Paraguay
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 10 Feb 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.
This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 [COVID-19] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Convalescent plasma | Experimental | Biological: Convalescent plasmaCOVID-19 convalescent plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 Years and older
- Presence of risk factors of severe COVID 19 diagnosed by quantitative polymerase chain reaction by reverse transcription (RT-qPCR)
- Patients with no more than 15 days from the onset of symptoms
- Signed informed consent
Key exclusion criteria (5 listed)
- Severely ill patients admitted directly to the ICU.
- Need for mechanical ventilation at the time of hospital admission, regardless of the time of clinical evolution.
- History of previous hypersensitivity to plasma transfusions.
- History of immunoglobulin A (IgA) deficiency
- Pregnancy
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 |
|---|---|---|
| Convalescent plasmaCOVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2 | Biological | Convalescent plasma |
Primary outcome
Overall survival (30-day mortality)
Time frame: 30 days
To evaluate the effectiveness of convalescent plasma therapy COVID-19, to decrease mortality in hospitalized patients with COVID-19 and who present some risk factor for clinical deterioration.
8 secondary outcomes
Median length of hospital stay
Time frame: 30 days
Change in clinical status
Time frame: 0, 3, 7 and 14 days
Change in inflammatory marker: ferritin
Time frame: 0, 7 and 14 days
Change in inflammatory marker: D dimer
Time frame: 0, 7 and 14 days
Change in inflammatory marker: leukocytes
Time frame: 0, 7 and 14 days
Serum Antibody Titers
Time frame: 0, 3 and 7 days
Transfer to ICU
Time frame: 30 days
Transfusion related events
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Background: PubMed 33300012Yoon HA, Bartash R, Gendlina I, Rivera J, Nakouzi A, Bortz RH 3rd, Wirchnianski AS, Paroder M, Fehn K, Serrano-Rahman L, Babb R, Sarwar UN, Haslwanter D, Laudermilch E, Florez C, Dieterle ME, Jangra RK, Fels JM, Tong K, Mariano MC, Vergnolle O, Georgiev GI, Herrera NG, Malonis RJ, Quiroz JA, Morano NC, Krause GJ, Sweeney JM, Cowman K, Allen S, Annam J, Applebaum A, Barboto D, Khokhar A, Lally BJ, Lee A, Lee M, Malaviya A, Sample R, Yang XA, Li Y, Ruiz R, Thota R, Barnhill J, Goldstein DY, Uehlinger J, Garforth SJ, Almo SC, Lai JR, Gil MR, Fox AS, Chandran K, Wang T, Daily JP, Pirofski LA. Treatment of Severe COVID-19 with Convalescent Plasma in the Bronx, NYC. medRxiv [Preprint]. 2020 Dec 4:2020.12.02.20242909. doi: 10.1101/2020.12.02.20242909.
- Background: PubMed 32861333Joyner MJ, Bruno KA, Klassen SA, Kunze KL, Johnson PW, Lesser ER, Wiggins CC, Senefeld JW, Klompas AM, Hodge DO, Shepherd JRA, Rea RF, Whelan ER, Clayburn AJ, Spiegel MR, Baker SE, Larson KF, Ripoll JG, Andersen KJ, Buras MR, Vogt MNP, Herasevich V, Dennis JJ, Regimbal RJ, Bauer PR, Blair JE, van Buskirk CM, Winters JL, Stubbs JR, van Helmond N, Butterfield BP, Sexton MA, Diaz Soto JC, Paneth NS, Verdun NC, Marks P, Casadevall A, Fairweather D, Carter RE, Wright RS. Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients. Mayo Clin Proc. 2020 Sep;95(9):1888-1897. doi: 10.1016/j.mayocp.2020.06.028. Epub 2020 Jul 19.
- BackgroundClinical Management of COVID-19 - Interim guidance 27 May 2020. WHO reference number: WHO/2019-nCoV/clinical/2020.5
- Open data' page of projects funded by CONACYT, ParaguayLink provided by the sponsor.
- Individual participant dataSharing planned: No. The investigators will publish the results to compare data with other studies with COVID-19 convalescent plasma patients
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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.
Angelica Jimenez de Samudio, MD,MSc principal investigator
Facultad de Ciencias Médicas - Universidad Nacional de Asunción
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Convalescent plasma in people with SARS-CoV-2 Infection and COVID-19 Infection, run by Universidad Nacional de Asunción at 1 site in Paraguay.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 2 Mar 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 Paraguay. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (30-day mortality) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04747158, which also lists 3 linked publications.
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 2 Mar 2021.