COVID-19Phase 2NCT04528368
Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
A Phase 2 study testing Convalescent plasma in people with COVID-19, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial summary
The COVID-19 pandemic has been spreading continuously, and in Brazil, until August 18, 2020, there have been more than 3,359,000 cases with more than 108,536 deaths, with daily increases. Read more about this study
- Who is it for?
- Any age
- 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
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Dec 2020to 30 Jan 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Recipient Inclusion Criteria:
- Confirmed diagnosis of COVID-19 by RT-PCR;
- Time between symptom onset and inclusion ≤ 7 days;
- Chest tomography with <50% involvement of the lung parenchyma;
- No indication of ventilatory support at the time of randomization;
- Sign the consent form.
Recipient Exclusion Criteria:
- Contraindication to transfusion or history of previous reactions to blood products for transfusion;
- Pregnant women;
- Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.
Donor Inclusion Criteria for Plasmapheresis:
- Convalescent plasma donation will be eligible for patients ≥ 18 years old who had previously confirmed COVID-19 by RT-PCR, which met the criteria adopted by technical notes n13 and 21/2020-CGSH/DAET/SAES/MS;
- SARS-COV-2 negative RT-PCR;
- Asymptomatic for at least 14 days;
- SARS-CoV-2 anti-peak titre with dilution ≥ 1: 320;
- Sign the consent form.
Donor Exclusion Criteria:
- Female gender with previous pregnancy;
- Absence of peripheral venous network compatible with the apheresis procedure;
- Positive or indeterminate result in any of the infectious screening tests;
- Presence of intellectual incapacity to understand the guidelines regarding the risks and benefits of participating in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
D'Or Institute for Research and Education
Rio de Janeiro
Eduardo M Rego, MD, PhD
Eduardo M Rego, MD, PhD
About this study
Official title: Efficacy and Safety of Using Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
The COVID-19 pandemic has been spreading continuously, and in Brazil, until August 18, 2020, there have been more than 3,359,000 cases with more than 108,536 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of using convalescent plasma for treating patients with COVID-19 pneumonia without indication of ventilatory support.
- Conditions
- COVID-19
- Being tested
- Convalescent plasma
- Keywords
- Convalescent plasma, SARS-CoV-2
- 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
The intervention group will receive 400 mL of convalescent plasma with a SARS-CoV-2 antispike antibody titer with a dilution ≥ 1: 320.
| Study group | Role | What they receive |
|---|---|---|
| Convalescent Plasma + Standard treatment | Experimental | Participants will receive the standard treatment and convalescent plasma Receives: Biological: Convalescent plasma |
| Standard treatment | No intervention | Participants will receive the standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs.
To evaluate the area under the curve of SARSCoV-2 viral load in nasopharyngeal and or oropharyngeal samples on days 0, 3, 6, 9, 12, 15, 18 and 15 after randomization.
Measured: 0, 3, 6, 9, 12, 15, 18 and 21 days
Secondary outcomes (12)
Assessment of clinical improvement using an Ordinal Severity Scale
The seven-point scale is as follows:
- Death 7 points;
- Hospital admission for mechanical ventilation plus additional organ support (eg, pressors, RRT, ECMO) = 6 points;
- Hospital admission for mechanical ventilation = 5 points;
- Hospital admission for non-invasive ventilation or high-flow oxygen therapy = 4 points;
- Hospital admission for oxygen therapy (but not requiring high-flow or non-invasive ventilation) = 3 points;
- Hospital admission but not requiring oxygen therapy = 2 points;
- Discharged with limitations of activities = 1 point;
- Discharged with no limitations of activities = 0 point;
Measured: 0, 7, 10, 14, 21 and 28 days
Evaluate oxygen saturation
Measured: 0, 3, 6, 9, 12, 15, 18 and 21 days
Evaluate oxygen supplementation
Measured: 0, 3, 6, 9, 12, 15, 18 and 21 days
Assess respiratory rate
Measured: 0, 3, 6, 9, 12, 15, 18 and 21 days
Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms)
Measured: 0, 3, 6, 9, 12, 15, 18 and 21 days
Length of hospital stay
Measured: 21 days
Length of stay in intensive care
Measured: 21 days
Assess the rate of orotracheal intubation
Measured: 21 days
Change in the profile of cytokines/chemokines in both groups
Quantification by ELISA the levels of 36 molecules determined simultaneously using the Human Cytokine Array Kit da R\&D Systems (C5a, IL-4, IL-32 alpha, CD40 ligand, IL-5, CXCL10 / IP-10, G-CSF, IL-6, CXCL11 / I-TAC, GM-CSF, IL-8, CCL2 / MCP-1, CXCL1 / GRO alpha, IL-10, MIF, CCL1 / I-309, IL-12 p70, CCL3 / MIP-1 alpha, ICAM-1, IL-13, CCL4 / MIP-1 beta, IFN -gamma, IL-16, CCL5 / RANTES, IL-1 alpha, IL-17, CXCL12 / SDF-1, IL-1 beta, IL-17E, Serpin E1 / PAI-1, IL-1ra, IL-23, TNF-alpha, IL-2, IL-27 and TREM-1)
Measured: 0, 3, 6, 9, 12, 15, 18 and 21 days
Presence of antibodies against SARS-CoV-2 in serum after convalescent plasma administration
Measured: 0, 3, 6, 9, 12, 15, 18 and 21 days
Death rate
Measured: 7, 10, 14, 21 and 28 days
Rate of transfusion reactions to convalescent plasma infusion
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start11 Dec 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital do Coracao
- Responsible party
- Sponsor
- Investigators
- Eduardo M Rego, MD, PhD, Principal investigator, D'Or Institute for Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528368
- Sponsor's protocol ID
- 34651120.8.0000.5249
- Status last verified
- Jan 2021
- First submitted
- 19 Aug 2020
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Using Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
- ClinicalTrials.gov ID
- NCT04528368
- Acronym / sponsor ID
- 34651120.8.0000.5249
- Conditions
- COVID-19
- Keywords
- Convalescent plasma, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Hospital do Coracao
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 27 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.
The COVID-19 pandemic has been spreading continuously, and in Brazil, until August 18, 2020, there have been more than 3,359,000 cases with more than 108,536 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of using convalescent plasma for treating patients with COVID-19 pneumonia without indication of ventilatory support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convalescent Plasma + Standard treatment | Experimental | Biological: Convalescent plasmaParticipants will receive the standard treatment and convalescent plasma |
| Standard treatment | No intervention | –Participants will receive the standard treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 plasmaThe intervention group will receive 400 mL of convalescent plasma with a SARS-CoV-2 antispike antibody titer with a dilution ≥ 1: 320. | Biological | Convalescent Plasma + Standard treatment |
Primary outcome
Area under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs.
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
To evaluate the area under the curve of SARSCoV-2 viral load in nasopharyngeal and or oropharyngeal samples on days 0, 3, 6, 9, 12, 15, 18 and 15 after randomization.
12 secondary outcomes
Assessment of clinical improvement using an Ordinal Severity Scale
Time frame: 0, 7, 10, 14, 21 and 28 days
Evaluate oxygen saturation
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Evaluate oxygen supplementation
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Assess respiratory rate
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms)
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Length of hospital stay
Time frame: 21 days
Length of stay in intensive care
Time frame: 21 days
Assess the rate of orotracheal intubation
Time frame: 21 days
Change in the profile of cytokines/chemokines in both groups
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Presence of antibodies against SARS-CoV-2 in serum after convalescent plasma administration
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Death rate
Time frame: 7, 10, 14, 21 and 28 days
Rate of transfusion reactions to convalescent plasma infusion
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- 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.
Eduardo M Rego, MD, PhD principal investigator
D'Or Institute for Research and Education
1 site 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 D'Or Institute for Research and Education at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo M Rego, MD, PhD (55 16 981110090, edumrego@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs. (time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days). 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 6 Aug 2021.