COVID-19Phase 2NCT04497324
PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19
A Phase 2 study testing Convalescent plasma in people with COVID-19, run by Universidad Peruana Cayetano Heredia at 2 sites in Peru.
Trial summary
Open label controlled clinical trial to evaluate the safety and efficacy of the use of convalescent plasma in hospitalized patients with COVID-19 infection. This study will have two arms, one arm will receive convalescent plasma plus standard of care, and the other arm will receive standard of care only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Convalescent plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesPeru
- Study dates
- 21 Sep 2020to 17 Apr 2021
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized 18 years old or older patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation.
- Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria:
- Respiratory frequency >22
- O2 saturation ≤93%
- PaO2 50mmHg
- PaO2/FiO2 <300
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- Or critical disease with one or more of the following criteria:
- Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours
- Shock
- Inform consent signed by patient or direct family member.
Who cannot join
- Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components
- Multiorgan failure, defined by a SOFA score of >5
- hemodynamically unstable, with mean arterial pressure <60 mmHg, refractory to vasopressors use
- Uncontrolled concomitant infection
- Disseminated intravascular coagulation
- Myocardial infarction
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- Acute coronary disease
- Patient on dialysis
- Intracranial bleeding active within the last 7 days
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Peru2 sites
Hospital Cayetano Heredia
Lima, 15102
Hospital Nacional Hipolito Unanue
Lima
About this study
Official title: PERUCONPLASMA: Randomized Clinical Trial to Evaluate Safety and Efficacy of the Use of Convalescent Plasma in Hospitalized Patients With COVID-19
Open label controlled clinical trial to evaluate the safety and efficacy of the use of convalescent plasma in hospitalized patients with COVID-19 infection. This study will have two arms, one arm will receive convalescent plasma plus standard of care, and the other arm will receive standard of care only. Adults older than 18 years old, hospitalized with diagnosis of COVID-19 confirmed by a laboratory test (molecular or serology), with severe or life-threatening disease, will be included to the study after obtaining inform consent by the patient of a direct family member. Participants will be then randomized 1:1 to the experimental and the control groups.
Participants at the experimental group will receive 1 to 2 units of ABO compatible COVID-19 convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of care. Participants at the control group will receive standard of care. Safety of convalescent plasma administration will be evaluated, as well as other indicators of clinical efficacy.
Read the detailed description
The study protocol can be found in:
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6
- Conditions
- COVID-19
- Being tested
- Convalescent plasma
- Keywords
- COVID-19, 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
Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care. Receives: Biological: Convalescent plasma |
| Control group | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion-related Serious Adverse Events
Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2
Measured: 14 days after randomization
Secondary outcomes (6)
All-cause in-hospital mortality
Death during hospitalization within the first 30 days after enrollment
Measured: 30 days after randomization
Length of hospital stay
Number of days from date of enrollment to date of discharge
Measured: 30 days after randomization or until hospital discharge, whatever comes first
Length of ICU stay
Number of days from date of admission to the ICU to date of discharge from ICU
Measured: 30 days after randomization or until hospital discharge, whatever comes first
Need of invasive mechanical ventilation
Requirement of invasive mechanical ventilation (Yes/No). Evaluated only for those participants that were on non-invasive ventilatory support at time of randomization
Measured: 30 days after randomization or until hospital discharge, whatever comes first
Duration of mechanical ventilation
Number of days from date of intubation to date of successful extubation
Measured: 30 days after randomization or until hospital discharge, whatever comes first
Clinical Improvement at 14 days
Improvement of 2 or more points in the WHO progression scale
Measured: At 3, 14 and 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start21 Sep 2020
- Primary completion17 Apr 2021
- Study completion17 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fiorella Krapp Lopez, MD, MSc, Principal investigator, Universidad Peruana Cayetano HerediaPatricia Garcia Funegra, MD, MSc, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497324
- Sponsor's protocol ID
- PER-016-20
- Other IDs
- 20997
- Status last verified
- Mar 2021
- First submitted
- 31 Jul 2020
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soto A, Krapp F, Vargas A, Cabrejos L, Argumanis E, Garcia PL, Altamirano K, Montes M, Chacon-Uscamaita PR, Garcia PJ. Randomized clinical trial to evaluate safety and efficacy of convalescent plasma use among hospitalized patients with COVID-19 (PERUCONPLASMA): a structured summary of a study protocol for a randomized controlled trial. Trials. 2021 May 17;22(1):342. doi: 10.1186/s13063-021-05189-6.
PubMed 34001174
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERUCONPLASMA: Randomized Clinical Trial to Evaluate Safety and Efficacy of the Use of Convalescent Plasma in Hospitalized Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04497324
- Acronym / sponsor ID
- PER-016-20
- Conditions
- COVID-19
- Keywords
- COVID-19, Convalescent plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 17 Apr 2021 (actual)
- Study completion
- 17 Apr 2021 (actual)
- First posted
- 4 Aug 2020 (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.
Open label controlled clinical trial to evaluate the safety and efficacy of the use of convalescent plasma in hospitalized patients with COVID-19 infection. This study will have two arms, one arm will receive convalescent plasma plus standard of care, and the other arm will receive standard of care only. Adults older than 18 years old, hospitalized with diagnosis of COVID-19 confirmed by a laboratory test (molecular or serology), with severe or life-threatening disease, will be included to the study after obtaining inform consent by the patient of a direct family member. Participants will be then randomized 1:1 to the experimental and the control groups.
Participants at the experimental group will receive 1 to 2 units of ABO compatible COVID-19 convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of care. Participants at the control group will receive standard of care. Safety of convalescent plasma administration will be evaluated, as well as other indicators of clinical efficacy.
Detailed description
The study protocol can be found in:
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: Convalescent plasmaAdministration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care. |
| Control group | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Hospitalized 18 years old or older patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation.
- Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria:
- Or critical disease with one or more of the following criteria:
- Inform consent signed by patient or direct family member.
Key exclusion criteria (10 listed)
- Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components
- Multiorgan failure, defined by a SOFA score of >5
- hemodynamically unstable, with mean arterial pressure <60 mmHg, refractory to vasopressors use
- Uncontrolled concomitant infection
- Disseminated intravascular coagulation
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 plasmaAdministration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care. | Biological | Experimental group |
Primary outcome
Transfusion-related Serious Adverse Events
Time frame: 14 days after randomization
Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2
6 secondary outcomes
All-cause in-hospital mortality
Time frame: 30 days after randomization
Length of hospital stay
Time frame: 30 days after randomization or until hospital discharge, whatever comes first
Length of ICU stay
Time frame: 30 days after randomization or until hospital discharge, whatever comes first
Need of invasive mechanical ventilation
Time frame: 30 days after randomization or until hospital discharge, whatever comes first
Duration of mechanical ventilation
Time frame: 30 days after randomization or until hospital discharge, whatever comes first
Clinical Improvement at 14 days
Time frame: At 3, 14 and 30 days after randomization
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 28 Oct 2021.
- Derived from this study: PubMed 34001174Soto A, Krapp F, Vargas A, Cabrejos L, Argumanis E, Garcia PL, Altamirano K, Montes M, Chacon-Uscamaita PR, Garcia PJ. Randomized clinical trial to evaluate safety and efficacy of convalescent plasma use among hospitalized patients with COVID-19 (PERUCONPLASMA): a structured summary of a study protocol for a randomized controlled trial. Trials. 2021 May 17;22(1):342. doi: 10.1186/s13063-021-05189-6.
- Individual participant dataSharing planned: No
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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.
Fiorella Krapp Lopez, MD, MSc principal investigator
Universidad Peruana Cayetano Heredia
Patricia Garcia Funegra, MD, MSc principal investigator
Universidad Peruana Cayetano Heredia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Convalescent plasma in people with COVID-19, run by Universidad Peruana Cayetano Heredia at 2 sites in Peru.
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 10 inclusion and 10 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Peru. 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 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.
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?
Transfusion-related Serious Adverse Events (time frame: 14 days after randomization). 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 NCT04497324, which also lists 1 linked publication.
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 28 Oct 2021.