Clinical trial NCT05046652: Effectiveness of Convalescent Plasma Therapy in 8 Non-Intubated COVID-19 Patients in Indonesia: A Case Series
Official title: Effectiveness of Convalescent Plasma Therapy in 8 Non-Intubated COVID-19 Patients in Indonesia: A Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Disease
Keywords: convalescent plasma therapy
non-intubated
case studies
COVID-19
SARS-CoV-2
Lead sponsor: Maranatha Christian University
Sponsor class: OTHER
Collaborators: name: Primaya Hospital Tangerang Indonesia
First posted: 2021-09-16
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eight patients originated from one region of Tangerang with positive PCR swab

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.

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

Primary outcomes:
measure: Patients with two doses of CP tended to have faster recovery than those with one dose of CP.
timeFrame: 1 April 2020 - 31 December 2020
Secondary outcomes:
measure: Patients with two doses of CP tended to have faster PCR negative conversion time than those with one dose of CP
timeFrame: 1 April 2020 - 31 December 2020
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Theresia Monica Monica
state: West Java
Study officials:
affiliation: Maranatha Christian University
name: Theresia M Rahardjo, Dr
role: PRINCIPAL_INVESTIGATOR
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