PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19

Universidad Peruana Cayetano Heredia

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Biological: Convalescent plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04497324

20997

PER-016-20

Details and patient eligibility

About

Open label controlled clinical trial to evaluate the safety and efficacy of the use of convalescent plasma in hospitalized patients with COVID-19 infection. This study will have two arms, one arm will receive convalescent plasma plus standard of care, and the other arm will receive standard of care only. Adults older than 18 years old, hospitalized with diagnosis of COVID-19 confirmed by a laboratory test (molecular or serology), with severe or life-threatening disease, will be included to the study after obtaining inform consent by the patient of a direct family member. Participants will be then randomized 1:1 to the experimental and the control groups.

Participants at the experimental group will receive 1 to 2 units of ABO compatible COVID-19 convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of care. Participants at the control group will receive standard of care. Safety of convalescent plasma administration will be evaluated, as well as other indicators of clinical efficacy.

Full description

The study protocol can be found in:

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalized 18 years old or older patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation.

• Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria:

  • Respiratory frequency >22
  • O2 saturation ≤93%
  • PaO2 50mmHg
  • PaO2/FiO2 <300

• Or critical disease with one or more of the following criteria:

  • Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours
  • Shock

• Inform consent signed by patient or direct family member.

Exclusion criteria

• Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components
• Multiorgan failure, defined by a SOFA score of >5
• hemodynamically unstable, with mean arterial pressure <60 mmHg, refractory to vasopressors use
• Uncontrolled concomitant infection
• Disseminated intravascular coagulation
• Myocardial infarction
• Acute coronary disease
• Patient on dialysis
• Intracranial bleeding active within the last 7 days
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Experimental group

Experimental group

Description:

Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.

Treatment:

Biological: Convalescent plasma

Control group

No Intervention group

Description:

Standard of care