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

NCT ID: NCT05046652

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2020-12-31

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.

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.

Conditions

Infectious Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

One bag of convalescent plasma therapy

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

Convalescent Plasma Therapy

Intervention Type: BIOLOGICAL

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.

Convalescent Plasma Therapy

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• COVID-19 patients
• Severe stage
• Positive PCR swab

Exclusion Criteria

• Non-COVID-19 patients
• No Symptoms COVID-19 patients
• Mild COVID-19 patients

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Primaya Hospital Tangerang Indonesia

UNKNOWN

Sponsor Role: collaborator

Maranatha Christian University

OTHER

Sponsor Role: lead

Responsible Party

Theresia Monica Rahardjo

Director of Unggul Karsa Medika Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theresia M Rahardjo, Dr

Role: PRINCIPAL_INVESTIGATOR

Maranatha Christian University

Locations

Theresia Monica Monica

Bandung, West Java, Indonesia

Countries

Indonesia

References

Indonesia: WHO Coronavirus Disease (COVID-19) Dashboard | WHO Coronavirus Disease (COVID-19) Dashboard

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Other Identifiers

0408087106

Identifier Type: -

Identifier Source: org_study_id