Effectiveness of Convalescent Plasma Therapy in 8 Non-Intubated COVID-19 Patients in Indonesia: A Case Series

Sponsor

Maranatha Christian University (Other)

Overall Status

Completed

CT.gov ID

NCT05046652

Collaborator

Primaya Hospital Tangerang Indonesia (Other)

Enrollment

Location

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is the first Case Studies article highlight factors determine the effectiveness of Convalescent Plasma Therapy (CPT) in Indonesia, accompanied by supporting data and images before and after the patients received the therapy. This Case Studies gives a huge contribution as CPT still on going as multicentre study and apply massively as emergency approved treatment in Indonesia.

Condition or Disease	Intervention/Treatment	Phase
Infectious Disease	Biological: Convalescent Plasma Therapy

Detailed Description

Eight non-intubated Covid-19 patients confirmed by real-time viral RNA PCR tests were included. Four patients had been administered two doses of 200 mL convalescent plasma (CP) and another four patients had been administered one dose of CP with an antibody titer of 1:320. This study has three goals included to detect the improvement of patient clinical and laboratory conditions, safety of CPT, and conversion from positive to negative results after CPT administration. Convalescent plasma applied within two weeks (13 days) from onset of illness and within a week (6.5 days) from the first day of hospital admission for all patients. Improvements in clinical symptoms, laboratory parameters, thorax photo, negative conversion of PCR, and decreased oxygen supplementation occurred within a week after CPT. Patients with two doses of CP tended to have faster recovery than those with one dose of CP. No severe adverse effects were observed in any patient. This is the first case series in Indonesia showing CPT is safe and well tolerated, and early CPT before the patient is intubated could potentially prevent disease progression, increase the recovery rate, and shorten the inpatient days.

Study Design

Study Type:

Observational

Actual Enrollment :

8 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Effectiveness of Convalescent Plasma Therapy in 8 Non-Intubated COVID-19 Patients in Indonesia: A Case Series

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
One bag of convalescent plasma therapy Four patients had been administered one dose of 200 mL CP with an antibody titer of 1:320.	Biological: Convalescent Plasma Therapy In this study, eight non-intubated Covid-19 patients confirmed by real-time viral RNA PCR tests were included. Four patients had been administered two doses of 200 mL convalescent plasma (CP) and another four patients had been administered one dose of CP with an antibody titer of 1:320.
Two bags of convalescent plasma therapy Four patients had been administered two doses of 200 mL CP with an antibody titer of 1:320.	Biological: Convalescent Plasma Therapy In this study, eight non-intubated Covid-19 patients confirmed by real-time viral RNA PCR tests were included. Four patients had been administered two doses of 200 mL convalescent plasma (CP) and another four patients had been administered one dose of CP with an antibody titer of 1:320.

Arm

Intervention/Treatment

One bag of convalescent plasma therapy

Four patients had been administered one dose of 200 mL CP with an antibody titer of 1:320.

Biological: Convalescent Plasma Therapy

In this study, eight non-intubated Covid-19 patients confirmed by real-time viral RNA PCR tests were included. Four patients had been administered two doses of 200 mL convalescent plasma (CP) and another four patients had been administered one dose of CP with an antibody titer of 1:320.

Two bags of convalescent plasma therapy

Four patients had been administered two doses of 200 mL CP with an antibody titer of 1:320.

Biological: Convalescent Plasma Therapy

Outcome Measures

Primary Outcome Measures

Patients with two doses of CP tended to have faster recovery than those with one dose of CP. [1 April 2020 - 31 December 2020]
The median time from onset of illness to CPT was 13 days (within two weeks), and from the first day of hospital admission to CPT was 6.5 days (within a week). There were improvements in clinical symptoms, laboratory parameters, thorax photo, negative conversion of PCR, and decreased oxygen supplementation within a week after CPT. No severe adverse effects were observed in any patient.

Secondary Outcome Measures

Patients with two doses of CP tended to have faster PCR negative conversion time than those with one dose of CP [1 April 2020 - 31 December 2020]
All four patients given two doses of CP became negative in PCR swab but only two of four patients given one dose of CPT showed negative PCR swab result