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Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients With COVID-19

NCT04567173 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-05-24

No results posted yet for this study

Summary

This protocol provides access to investigational convalescent plasma for hospitalized patients with COVID-19. Following provision of informed consent, patients will be administered around 500 mL of convalescent plasma obtained from an individual who has recovered from a documented SARS-CoV-2 infection. The study aims to evaluate the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as adjunctive therapy in preventing disease progression (prevention of ICU admission) among hospitalized patients with COVID-19. Safety outcomes include serious adverse events judged to be related to convalescent plasma. Other information which will be collected includes patient demographics and clinical data which includes quick SOFA scores, ventilator-free days, ICU-free days, dialysis-free days and 28-day mortality.

Conditions

  • Covid19

Interventions

DRUG

Anti-SARS-CoV-2 convalescent plasma

convalescent plasma derived from whole blood donors or standard pheresis from a volunteer who recovered from COVID-19

Sponsors & Collaborators

  • University of the Philippines

    lead OTHER

Principal Investigators

  • Deonne Thaddeus V Gauiran, MD · UP Philippine General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04567173 on ClinicalTrials.gov