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

Completed

• Conditions: Infectious Disease
• Interventions: Biological: Convalescent Plasma Therapy

• Registration Number: NCT05046652
• Lead Sponsor: Maranatha Christian University

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.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Study First Submitted: 2021-04-12
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-13
• Last Update Submitted: 2021-09-13
• Study First Posted: 2021-09-16
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
One bag of convalescent plasma therapy	Convalescent Plasma Therapy	Four patients had been administered one dose of 200 mL CP with an antibody titer of 1:320.
Two bags of convalescent plasma therapy	Convalescent Plasma Therapy	Four patients had been administered two doses of 200 mL CP with an antibody titer of 1:320.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Theresia Monica Monica; 🇮🇩 Bandung, West Java, Indonesia