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

NCT05046652 | Completed DMC

• 1 other identifier: 0408087106
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Disease

Keywords

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

Outcome Measures

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.

  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

  1 April 2020 - 31 December 2020

Study Arms (2)

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

Convalescent Plasma Therapy 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.

One bag of convalescent plasma therapy; Two bags of convalescent plasma therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maranatha Christian University: lead
• Primaya Hospital Tangerang Indonesia: collaborator

Study Sites (1)

Theresia Monica Monica

Bandung, West Java, 40164, Indonesia

Location

Related Publications (15)

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

  BACKGROUND

• Ozdemir OHE. Convalescent (Immune) Plasma Therapy with all Aspects: Yesterday, Today and COVID-19. Erciyes Med J. 2020;1-8.

  BACKGROUND

• Rahardjo TM, Triyono T, Harly PR. Buku Penatalaksanaan Terapi Plasma Konvalesen Bagi Pasien COVID-19 Di Indonesia. Revised Edition. September 2020.

  BACKGROUND

• 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.

  PMID: 32167489 RESULT

• 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.

  PMID: 32792417 RESULT

• 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.

  PMID: 32254064 RESULT

• 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.

  PMID: 32253318 RESULT

• 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.

  PMID: 32219428 RESULT

• 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.

  PMID: 32694043 RESULT

• 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.

  PMID: 32934372 RESULT

• 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.

  PMID: 33406353 RESULT

• 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.

  PMID: 15616839 RESULT

• 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.

  PMID: 32634589 RESULT

• 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.

  PMID: 17855683 RESULT

• 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.

  PMID: 33621405 RESULT

MeSH Terms

Conditions

Communicable Diseases; COVID-19

Interventions

Immunization, Passive

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Theresia M Rahardjo, Dr

  Maranatha Christian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Unggul Karsa Medika Hospital

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: September 16, 2021
• Study Start: April 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)