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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: Convalescent plasma

Detailed Description

The study protocol can be found in:

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Peru
  • Lima, Peru, 15102
    • Hospital Cayetano Heredia
  • Lima, Peru
    • Hospital Nacional Hipolito Unanue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.	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.
NO_INTERVENTION: Control group; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause in-hospital mortality	Death during hospitalization within the first 30 days after enrollment	30 days after randomization
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
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
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
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
Clinical Improvement at 14 days	Improvement of 2 or more points in the WHO progression scale	At 3, 14 and 30 days after randomization

Collaborators and Investigators

• Sponsor: Universidad Peruana Cayetano Heredia
• Investigators: Principal Investigator: Fiorella Krapp Lopez, MD, MSc, Universidad Peruana Cayetano Heredia; Principal Investigator: Patricia Garcia Funegra, MD, MSc, Universidad Peruana Cayetano Heredia

Publications and helpful links

General Publications

• Soto A, Krapp F, Vargas A, Cabrejos L, Argumanis E, Garcia PL, Altamirano K, Montes M, Chacon-Uscamaita PR, Garcia PJ. Randomized clinical trial to evaluate safety and efficacy of convalescent plasma use among hospitalized patients with COVID-19 (PERUCONPLASMA): a structured summary of a study protocol for a randomized controlled trial. Trials. 2021 May 17;22(1):342. doi: 10.1186/s13063-021-05189-6.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 21, 2020
• Primary Completion (ACTUAL): April 17, 2021
• Study Completion (ACTUAL): April 17, 2021

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (ACTUAL): August 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Convalescent plasma
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PER-016-20; 20997 (REGISTRY: Peruvian Clinical Trial Registry (REPEC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No