Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-23

Study Completion Date

2020-09-30

Brief Summary

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Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease. This research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe COVID-19 disease.

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Detailed Description

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A randomized clinical trial comparing administration convalescent plasma to standard therapy for severe COVID-19 disease. Patients will be randomized 1:1 in a single blind study. The patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Our primary outcomes will be disease progression and mortality, evaluate of ordinal Scale for Clinical Improvement and. (WHO)

Conditions

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Severe COVID-19 Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The PC-COVID-HCM clinical trial is a randomized, controlled, single-blind study .

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The research was blinded as possible for the result's evaluators and those responsible for the statistical analysis. All patients admitted to the investigation were placed with a marker indicating that they were a patient of the plasma protocol, but not mention the study group. The data collectors and the outcome adjudicators were unaware of the treatment assignments.

Study Groups

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Control group

They will receive the standard care for critically ill inpatients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Convalescent plasma group.

They will receive standard care for patients with severe COVID-19 disease and convalescent plasma disease.

Group Type EXPERIMENTAL

Biological

Intervention Type BIOLOGICAL

An administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses.

If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out.

Interventions

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Biological

An administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses.

If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out.

Intervention Type BIOLOGICAL

Other Intervention Names

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Convalescent plasma

Eligibility Criteria

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Inclusion Criteria

* O2 saturation \<93%
* Radiographic evidence of moderate pneumonia according to Rale's classification.
* Acute respiratory distress syndrome (PaO2 / FiO2 \<300 or SpO2 / FiO2 ≤ 315)
* Authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated)

Exclusion Criteria

* Pregnant patients
* History of transfusion reactions
* Patients with congestive heart failure
* Patients with a history of chronic kidney failure on dialysis
* Patients with multiple organ failure
* Patients who does not accept or agree with the treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No