Effect of COVID-19 convalescent plasma produced by HEMOPE: A randomized study, with a comparative group in several centers

Therapeutic effectiveness of COVID-19 convalescent plasma produced by HEMOPE: a multicenter, randomized and controlled clinical trial - PLAVID-TRIAL: Covid convalescent plasma - Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-7jqpnw

Enrollment

Unknown

Registered

2020-06-29

Start date

2020-07-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Interventions

C01.748.730

Experimental group: convalescent plasma + local standard of care for Covid-19 (110 participants). Control group: local standard of care for Covid-19 (110 participants)

Biological/vaccine

A12.207.152.693

D12.776.124.486.485.114

E02.120.770

B04.820.504.540.150.113

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: adults> 18 years with diagnosis of COVID – 19, who are hospitalized; and considered as having a condition that increases the risk of a worse prognosis: obesity; diabetes mellitus (DM); systemic arterial hypertension (SAH); chronic lung disease, obesity, diseases that alter immunity (AIDS, neoplasms or autoimmune diseases in immunosuppressive therapy, chronic liver disease.

Exclusion criteria

Exclusion criteria: History of anaphylactic reaction related to blood transfusion.

Design outcomes

Primary

Measure	Time frame
It is expected to find a 50% reduction in the frequency of lethality in the intervention group when compared to the control group	—

Secondary

Measure	Time frame
It is expected to find a reduction in the frequency of patients who require invasive mechanical ventilation after admission to the study, when compared to the control group;It is expected to find a reduction in the frequency of patients who need to be transferred to the Intensive Care Unit (ICU), when compared to the control group; It is expected to find a reduction in the average time of need for oxygen therapy in the intervention group when compared to the control group ;It is expected to find a reduction in the mean time of invasive mechanical ventilation in the intervention group when compared to the control group;It is expected to find a reduction in the average length of stay in the ICU in the intervention group when compared to that of the control group;It is expected to find a reduction in the average length of hospital stay in the intervention group when compared to the control group	—

Measure

Time frame

It is expected to find a reduction in the frequency of patients who require invasive mechanical ventilation after admission to the study, when compared to the control group;It is expected to find a reduction in the frequency of patients who need to be transferred to the Intensive Care Unit (ICU), when compared to the control group; It is expected to find a reduction in the average time of need for oxygen therapy in the intervention group when compared to the control group ;It is expected to find a reduction in the mean time of invasive mechanical ventilation in the intervention group when compared to the control group;It is expected to find a reduction in the average length of stay in the ICU in the intervention group when compared to that of the control group;It is expected to find a reduction in the average length of hospital stay in the intervention group when compared to the control group

—

Countries

Brazil

Contacts

Public ContactDemócrito Miranda Filho

Universidade de Pernambuco

demofilho@gmail.com+55 081 999764712

Outcome results

None listed

Source: REBEC (via WHO ICTRP)