A Phase 2 interventional study of Convalescent plasma in COVID-19, sponsored by Universidad Peruana Cayetano Heredia. Completed at 2 sites in Peru. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-28.
Sponsored by Universidad Peruana Cayetano Heredia · Phase 2, Interventional, and Treatment
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.
The study protocol can be found in:
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Universidad Peruana Cayetano Heredia is the lead sponsor of 49 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria:
Or critical disease with one or more of the following criteria:
Exclusion Criteria:
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
Standard of care
Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.
Transfusion-related Serious Adverse Events
Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2
Time frame: 14 days after randomization
All-cause in-hospital mortality
Death during hospitalization within the first 30 days after enrollment
Time frame: 30 days after randomization
Length of hospital stay
Number of days from date of enrollment to date of discharge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 3, 14 and 30 days after randomization
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Universidad Peruana Cayetano Heredia