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COVID-19Phase 2COOPCOVID-19NCT04415086

Treatment of Patients With COVID-19 With Convalescent Plasma

A Phase 2 study testing convalescent plasma in people with COVID-19, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The COVID-19 pandemic has been spreading continuously, and in Brazil, until May 31, 2020, there have been more than 450.000 cases with more than 28.000 deaths, with daily increases. 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?
Yes, some participants may receive a placebo
How many people
129 participants
Where
1 siteBrazil
Study dates
1 Jun 2020to 15 Feb 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age = or > than 18 years; .
  • Laboratory-proven COVID-19 infection by RT-PCR in any clinical sample . Time since symptom onset less than 10 days at the time of screening; - . Presence of COVID-19 pneumonia, with a typical, indeterminate or atypical compatible image in a chest tomography exam (see definition below) -
  • Presence of one of the following criteria:
  • Need for> 3L of O2 in the catheter / mask or> 25% in the Venturi mask to maintain O2 saturation> 92% B presence of respiratory distress syndrome with PaO2 / FiO2 <300mmHg If intubated, within 48 hours of orotracheal intubation
  • Absence of a history of serious adverse reactions to transfusion, for example, anaphylaxis; - .Participation approval by the research clinician

Who cannot join

  • Already enrolled in another clinical trial evaluating antiviral or immunobiological therapy for the treatment of COVID-19.
  • IgA deficiency
  • Presence of a clinical condition that does not allow infusion of 400 ml of volume at clinical discretion
  • Pregnancy or breastfeeding
  • Receipt of immunoglobulin in the last 30 days
  • Presence of significant risk of death within the next 48 hours at clinical discretion.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • University of Sao Paulo - General Hospital

    São Paulo, São Paulo, 01403-002

Other trials in Brazil

About this study

Official title: Treatment of Patients With COVID-19 With Convalescent Plasma Transfusion: a Multicenter, Open-labeled, Randomized and Controlled Study

The COVID-19 pandemic has been spreading continuously, and in Brazil, until May 31, 2020, there have been more than 450.000 cases with more than 28.000 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of convalescent plasma in treatment of severe cases of COVID-19 in a multicenter, randomized, open-label and controlled study

Read the detailed description

Eligible patients will be randomized 1:1:1 into 3 treatment groups: A- standard (control); B- standard and convalescent plasma in a volume of 200ml (150-300ml); C- standard and convalescent plasma in a volume of 400ml (300-600ml). The Bayesian multi-arm and multi-stage model will be used, which will allow an interim analysis after the inclusion of 30 patients, with repeated interim analyses for every 30 additional patients. With this, we expect to define not only the efficacy of convalescent plasma, but also the volume of plasma needed if efficacy is proven. The study will be interrupted if the efficacy of the convalescent plasma group is proven, so that all severely ill patients as defined in the study can receive the convalescent plasma treatment. The same will occur if there is no difference in primary outcome with the use of convalescent plasma or serious adverse effects.

Conditions
COVID-19
Being tested
convalescent plasma
Keywords
COVID-19, convalescent plasma, efficacy, safety
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 study will be interrupted if the efficacy of the convalescent plasma group is proven, so that all severely ill patients as defined in the study can receive the convalescent plasma treatment. The same will occur if there is no difference in primary outcome with the use of convalescent plasma or serious adverse effects.

Study groups in NCT04415086
Study groupRoleWhat they receive
Group ASham comparatorParticipants will receive the standard of care treatment
Receives: Biological: convalescent plasma
Group BActive comparatorParticipants will receive the standard treatment and convalescent plasma in a volume of 200ml (150-300ml)
Receives: Biological: convalescent plasma
Group CActive comparatorParticipants will receive the standard treatment and convalescent plasma in a volume of 400ml (300-600ml)
Receives: Biological: convalescent plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time elapsed until clinical improvement or hospital discharge

    clinical improvement is defined as the time from the randomization date until the decline of 2 categories on the ordinal scale of 10 categories or hospital discharge (whichever comes first)

    Measured: Follow up until 28 days after transfusion

Secondary outcomes (6)

  1. acute adverse events

    incidence of acute adverse events possibly or definitively realted to convalescent plasma transfusion

    Measured: Up to 12 hours after transfusion

  2. Clinical Status

    Evaluation according to an ordinal scale of 10 categories

    Measured: "Day 7", "Day 14" and "Day 28"

  3. Duration of clinical events

    Duration of mechanical ventilation, length of hospital stay in survivors up to 28 days and time from the beginning of treatment to death

    Measured: Up to 28 days

  4. SARS-CoV-2 in nasopharyngeal swab

    Detection of SARS-CoV-2 in nasopharyngeal swab

    Measured: Days 0, 1, 3, 7, 14 and 28 after transfusion and control groups

  5. IgG, IgM and IgA titers for SARS-CoV-2

    Specific IgG, IgM and IgA titers for SARS-CoV-2

    Measured: Days 0, 1, 3, 5, 7, 14 and 28 after transfusion and control groups

  6. Neutralizing antibodies

    Titers of neutralizing antibodies

    Measured: 0,1,7 14 and 28 days after transfusion and control groups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start1 Jun 2020
  3. Primary completion15 Feb 2022
  4. Study completion15 Feb 2022

Resources

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
Model description
1:1:1 into 3 treatment groups: A- standard (control); B- standard and convalescent plasma in a volume of 200ml (150-300ml); C- standard and convalescent plasma in a volume of 400ml (300-600ml)
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04415086
Sponsor's protocol ID
COOP-COVID-19-MCTIC
Acronym
COOPCOVID-19
Status last verified
Oct 2021
First submitted
1 Jun 2020
Last updated
19 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Song ATW, Rocha V, Mendrone-Junior A, Calado RT, De Santis GC, Benites BD, Costa-Lima C, Vargas T, Marques LS, Fernandes JC, Breda FC, Wendel S, Fachini R, Rizzo LV, Kutner JM, Avelino-Silva VI, Machado RRG, Durigon EL, Chevret S, Kallas EG. Treatment of severe COVID-19 patients with either low- or high-volume of convalescent plasma versus standard of care: A multicenter Bayesian randomized open-label clinical trial (COOP-COVID-19-MCTI). Lancet Reg Health Am. 2022 Jun;10:100216. doi: 10.1016/j.lana.2022.100216. Epub 2022 Mar 15.

    PubMed 35308034

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing convalescent plasma in people with COVID-19, run by University of Sao Paulo General Hospital at 1 site in Brazil.

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 5 inclusion and 6 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 19 May 2022. 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. Some participants in this study may receive a placebo. 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?

Time elapsed until clinical improvement or hospital discharge (time frame: Follow up until 28 days after transfusion). 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 NCT04415086, 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 19 May 2022.

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