Convalescent Plasma as Adjunct Therapy for COVID-19

Summary

Convalescent plasma (CP) has been the subject of increasing expectation for treating coronavirus disease 2019 (COVID-19). Reports on CP transfusion have shown promising clinical improvements without serious adverse events. To date, most studies focused on reporting CP treatment in patients with severe COVID-19, but only a few addressed benefits on less severe disease. The vast majority of studies reporting COVID-19 infection and treatment have come from earlier affected countries with established health systems and research infrastructure, while very few are from low- and middle-income countries (LMICs). Nonetheless, CP therapy could be one of the few available options in LMICs where constraints may exist in the access to novel treatments, even once available. Clinical trials conducted in LMICs may differ in many respects from those in high-income countries.

This study will evaluate the safety and efficacy of convalescent plasma therapy in hospitalized with moderate and severe COVID-19, to investigate the impacts of the treatment over the course of clinical illness, including non-mortal clinical outcomes.

Conditions

• COVID-19

Interventions

BIOLOGICAL

Convalescent plasma treatment

Convalescent Plasma collected from patients who recover from COVID-19 and have been discharged from the hospital for at least 14 days.

Sponsors & Collaborators

• Indonesian Red Cross

  collaborator UNKNOWN

• Eijkman Institute for Molecular Biology

  collaborator OTHER

• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

  lead OTHER

Principal Investigators

• David H Muljono, MD, PhD. · Eijkman Institute for Molecular Biology

• Irmansyah, MD, PhD · National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

• Sri Idaiani, MD, PhD · National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

• Tetra Fajarwati, MD,PhD · National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-01

Primary Completion

2021-10-30

Completion

2021-12-31

Countries

• Indonesia

Study Locations