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

Hospital Central Militar

Status and phase: Completed; Phase 2

Conditions: Severe COVID-19 Disease

Treatments: Biological: Biological

Study type: Interventional

Funder types: Other

Identifiers

NCT04542967

047/2020

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 150 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Control group

No Intervention group

Description:

They will receive the standard care for critically ill inpatients.

Convalescent plasma group.

Experimental group

Description:

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

Treatment:

Biological: Biological