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

NCT04497324 | Completed Phase 2 DMC

• 2 other identifiers: PER-016-2020997
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

COVID-19

Keywords

COVID-19; Convalescent plasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• All-cause in-hospital mortality

  30 days after randomization

• Length of hospital stay

  30 days after randomization or until hospital discharge, whatever comes first

• Length of ICU stay

  30 days after randomization or until hospital discharge, whatever comes first

• Need of invasive mechanical ventilation

  30 days after randomization or until hospital discharge, whatever comes first

• Duration of mechanical ventilation

  30 days after randomization or until hospital discharge, whatever comes first

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Standard of care

Interventions

Convalescent plasma BIOLOGICAL

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead

Study Sites (2)

Hospital Cayetano Heredia

Lima, 15102, Peru

Location

Hospital Nacional Hipolito Unanue

Lima, Peru

Location

Related Publications (1)

• 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.

  PMID: 34001174 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fiorella Krapp Lopez, MD, MSc

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

• Patricia Garcia Funegra, MD, MSc

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 4, 2020
• Study Start: September 21, 2020
• Primary Completion: April 17, 2021
• Study Completion: April 17, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PE (2)