NCT04497324

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Universidad Peruana Cayetano Heredia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study protocol can be found in: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6

Conditions

• COVID-19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-21
• Primary completion: 2021-04-17
• Completion: 2021-04-17
• First posted: 2020-08-04
• Last updated: 2021-10-28

Locations

2 sites across 1 country: Peru