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

COVID-19 Clinical Trial

Official title:

PERUCONPLASMA: Randomized Clinical Trial to Evaluate Safety and Efficacy of the Use of Convalescent Plasma in Hospitalized Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04497324
• Other study ID #: PER-016-20
• Secondary ID: 20997
• Status: Completed
• Phase: Phase 2
• Start date: September 21, 2020
• Est. completion date: April 17, 2021

Study information

• Verified date: March 2021
• Source: Universidad Peruana Cayetano Heredia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The study protocol can be found in:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 17, 2021
• Est. primary completion date: April 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Peru	Hospital Cayetano Heredia	Lima
Peru	Hospital Nacional Hipolito Unanue	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion-related Serious Adverse Events	Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2	14 days after randomization
Secondary	All-cause in-hospital mortality	Death during hospitalization within the first 30 days after enrollment	30 days after randomization
Secondary	Length of hospital stay	Number of days from date of enrollment to date of discharge	30 days after randomization or until hospital discharge, whatever comes first
Secondary	Length of ICU stay	Number of days from date of admission to the ICU to date of discharge from ICU	30 days after randomization or until hospital discharge, whatever comes first
Secondary	Need of invasive mechanical ventilation	Requirement of invasive mechanical ventilation (Yes/No). Evaluated only for those participants that were on non-invasive ventilatory support at time of randomization	30 days after randomization or until hospital discharge, whatever comes first
Secondary	Duration of mechanical ventilation	Number of days from date of intubation to date of successful extubation	30 days after randomization or until hospital discharge, whatever comes first
Secondary	Clinical Improvement at 14 days	Improvement of 2 or more points in the WHO progression scale	At 3, 14 and 30 days after randomization