ClinicalTrials.gg
CompletedNCT05046652Updated Sep 16, 2021

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

An observational study in Infectious Disease, sponsored by Maranatha Christian University. Completed at 1 site in Indonesia. Per ClinicalTrials.gov, last updated 2021-09-16.

Sponsored by Maranatha Christian University · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
8
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infectious Disease

Keywords

  • convalescent plasma therapy
  • non-intubated
  • case studies
  • COVID-19
  • SARS-CoV-2
03

In context

Communicable Diseases

626 studies on the registry are indexed under Communicable Diseases; 128 are open to participants now.

This study's enrollment of 8 is below the median of 200 across 228 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Maranatha Christian University is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All eight patients originated from one region of Tangerang with positive PCR swab

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Non-COVID-19 patients
  • No Symptoms COVID-19 patients
  • Mild COVID-19 patients
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
8 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • BiologicalConvalescent 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.

06

What researchers measure

Primary outcomes

  1. Patients with two doses of CP tended to have faster recovery than those with one dose of CP.

    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.

    Time frame: 1 April 2020 - 31 December 2020

Secondary outcomes

  1. Patients with two doses of CP tended to have faster PCR negative conversion time than those with one dose of CP

    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

    Time frame: 1 April 2020 - 31 December 2020

07

Study locations

1 site
  • Theresia Monica Monica
    Bandung, West Java 40164, Indonesia
08

References and documents

Publications

  • Indonesia: WHO Coronavirus Disease (COVID-19) Dashboard | WHO Coronavirus Disease (COVID-19) Dashboard
  • Ozdemir OHE. Convalescent (Immune) Plasma Therapy with all Aspects: Yesterday, Today and COVID-19. Erciyes Med J. 2020;1-8.
  • Rahardjo TM, Triyono T, Harly PR. Buku Penatalaksanaan Terapi Plasma Konvalesen Bagi Pasien COVID-19 Di Indonesia. Revised Edition. September 2020.
  • Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available. PubMed 32167489 ↗
  • Focosi D, Anderson AO, Tang JW, Tuccori M. Convalescent Plasma Therapy for COVID-19: State of the Art. Clin Microbiol Rev. 2020 Aug 12;33(4):e00072-20. doi: 10.1128/CMR.00072-20. Print 2020 Sep 16. PubMed 32792417 ↗
  • Bloch EM, Shoham S, Casadevall A, Sachais BS, Shaz B, Winters JL, van Buskirk C, Grossman BJ, Joyner M, Henderson JP, Pekosz A, Lau B, Wesolowski A, Katz L, Shan H, Auwaerter PG, Thomas D, Sullivan DJ, Paneth N, Gehrie E, Spitalnik S, Hod EA, Pollack L, Nicholson WT, Pirofski LA, Bailey JA, Tobian AA. Deployment of convalescent plasma for the prevention and treatment of COVID-19. J Clin Invest. 2020 Jun 1;130(6):2757-2765. doi: 10.1172/JCI138745. PubMed 32254064 ↗
  • Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6. PubMed 32253318 ↗
  • Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783. PubMed 32219428 ↗
  • Abolghasemi H, Eshghi P, Cheraghali AM, Imani Fooladi AA, Bolouki Moghaddam F, Imanizadeh S, Moeini Maleki M, Ranjkesh M, Rezapour M, Bahramifar A, Einollahi B, Hosseini MJ, Jafari NJ, Nikpouraghdam M, Sadri N, Tazik M, Sali S, Okati S, Askari E, Tabarsi P, Aslani J, Sharifipour E, Jarahzadeh MH, Khodakarim N, Salesi M, Jafari R, Shahverdi S. Clinical efficacy of convalescent plasma for treatment of COVID-19 infections: Results of a multicenter clinical study. Transfus Apher Sci. 2020 Oct;59(5):102875. doi: 10.1016/j.transci.2020.102875. Epub 2020 Jul 15. PubMed 32694043 ↗
  • Liu STH, Lin HM, Baine I, Wajnberg A, Gumprecht JP, Rahman F, Rodriguez D, Tandon P, Bassily-Marcus A, Bander J, Sanky C, Dupper A, Zheng A, Nguyen FT, Amanat F, Stadlbauer D, Altman DR, Chen BK, Krammer F, Mendu DR, Firpo-Betancourt A, Levin MA, Bagiella E, Casadevall A, Cordon-Cardo C, Jhang JS, Arinsburg SA, Reich DL, Aberg JA, Bouvier NM. Convalescent plasma treatment of severe COVID-19: a propensity score-matched control study. Nat Med. 2020 Nov;26(11):1708-1713. doi: 10.1038/s41591-020-1088-9. Epub 2020 Sep 15. PubMed 32934372 ↗
  • Libster R, Perez Marc G, Wappner D, Coviello S, Bianchi A, Braem V, Esteban I, Caballero MT, Wood C, Berrueta M, Rondan A, Lescano G, Cruz P, Ritou Y, Fernandez Vina V, Alvarez Paggi D, Esperante S, Ferreti A, Ofman G, Ciganda A, Rodriguez R, Lantos J, Valentini R, Itcovici N, Hintze A, Oyarvide ML, Etchegaray C, Neira A, Name I, Alfonso J, Lopez Castelo R, Caruso G, Rapelius S, Alvez F, Etchenique F, Dimase F, Alvarez D, Aranda SS, Sanchez Yanotti C, De Luca J, Jares Baglivo S, Laudanno S, Nowogrodzki F, Larrea R, Silveyra M, Leberzstein G, Debonis A, Molinos J, Gonzalez M, Perez E, Kreplak N, Pastor Arguello S, Gibbons L, Althabe F, Bergel E, Polack FP; Fundacion INFANT-COVID-19 Group. Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults. N Engl J Med. 2021 Feb 18;384(7):610-618. doi: 10.1056/NEJMoa2033700. Epub 2021 Jan 6. PubMed 33406353 ↗
  • Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9. PubMed 15616839 ↗
  • Sun M, Xu Y, He H, Zhang L, Wang X, Qiu Q, Sun C, Guo Y, Qiu S, Ma K. A potentially effective treatment for COVID-19: A systematic review and meta-analysis of convalescent plasma therapy in treating severe infectious disease. Int J Infect Dis. 2020 Sep;98:334-346. doi: 10.1016/j.ijid.2020.06.107. Epub 2020 Jul 4. PubMed 32634589 ↗
  • Cao WC, Liu W, Zhang PH, Zhang F, Richardus JH. Disappearance of antibodies to SARS-associated coronavirus after recovery. N Engl J Med. 2007 Sep 13;357(11):1162-3. doi: 10.1056/NEJMc070348. No abstract available. PubMed 17855683 ↗
  • Aviani JK, Halim D, Soeroto AY, Achmad TH, Djuwantono T. Current views on the potentials of convalescent plasma therapy (CPT) as Coronavirus disease 2019 (COVID-19) treatment: A systematic review and meta-analysis based on recent studies and previous respiratory pandemics. Rev Med Virol. 2021 Nov;31(6):e2225. doi: 10.1002/rmv.2225. Epub 2021 Feb 23. PubMed 33621405 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2020 to primary completion in Dec 2020, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 12, 2021
First posted
Sep 16, 2021
StartActual
Apr 1, 2020
Primary completionActual
Dec 31, 2020
CompletionActual
Dec 31, 2020
Last update
Sep 16, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05046652
Lead sponsor
Maranatha Christian University
Collaborators
Primaya Hospital Tangerang Indonesia
Responsible party
Theresia Monica Rahardjo (Director of Unggul Karsa Medika Hospital, Maranatha Christian University) — Principal investigator
First posted
Sep 16, 2021
Start date
Apr 1, 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Sep 16, 2021

Study contacts

Theresia M Rahardjo, Dr
principal investigator · Maranatha Christian University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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