Infectious DiseaseNCT05046652
Effectiveness of Convalescent Plasma Therapy in 8 Non-Intubated COVID-19 Patients in Indonesia: A Case Series
An observational study of Infectious Disease, run by Maranatha Christian University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious Disease
- What is being tested?
- Convalescent Plasma Therapy
- How many people
- 8 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All eight patients originated from one region of Tangerang with positive PCR swab
Who may be able to join
- COVID-19 patients
- Severe stage
- Positive PCR swab
Who cannot join
- Non-COVID-19 patients
- No Symptoms COVID-19 patients
- Mild COVID-19 patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Infectious Disease
- Being tested
- Convalescent Plasma Therapy
- Keywords
- convalescent plasma therapy, non-intubated, case studies, COVID-19, SARS-CoV-2
- Medical subject headings
- Communicable Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent Plasma TherapyBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| One bag of convalescent plasma therapy | Four patients had been administered one dose of 200 mL CP with an antibody titer of 1:320. Receives: 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. Receives: Biological: Convalescent Plasma Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 April 2020 - 31 December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Apr 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maranatha Christian University
- Sponsor type
- University, hospital or other
- Collaborators
- Primaya Hospital Tangerang Indonesia
- Responsible party
- Principal investigator, Theresia Monica Rahardjo, Maranatha Christian University
- Investigators
- Theresia M Rahardjo, Dr, Principal investigator, Maranatha Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046652
- Sponsor's protocol ID
- 0408087106
- Status last verified
- Sep 2021
- First submitted
- 12 Apr 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32167489Focosi 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 32792417Bloch 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 32254064Duan 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 32253318Shen 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 32219428Abolghasemi 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 32694043Liu 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 32934372Libster 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 33406353Cheng 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 15616839Sun 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 32634589Cao 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 17855683Aviani 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Convalescent Plasma Therapy in 8 Non-Intubated COVID-19 Patients in Indonesia: A Case Series
- ClinicalTrials.gov ID
- NCT05046652
- Acronym / sponsor ID
- 0408087106
- Conditions
- Infectious Disease
- Keywords
- convalescent plasma therapy, non-intubated, case studies, COVID-19, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Maranatha Christian UniversityUniversity, hospital or other
- Collaborators
- Primaya Hospital Tangerang Indonesia
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One bag of convalescent plasma therapy | – | Biological: Convalescent Plasma TherapyFour patients had been administered one dose of 200 mL CP with an antibody titer of 1:320. |
| Two bags of convalescent plasma therapy | – | Biological: Convalescent Plasma TherapyFour patients had been administered two doses of 200 mL CP with an antibody titer of 1:320. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All eight patients originated from one region of Tangerang with positive PCR swab
Key inclusion criteria (3 listed)
- COVID-19 patients
- Severe stage
- Positive PCR swab
Key exclusion criteria (3 listed)
- Non-COVID-19 patients
- No Symptoms COVID-19 patients
- Mild COVID-19 patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Convalescent Plasma TherapyIn 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. | Biological | One bag of convalescent plasma therapy, Two bags of convalescent plasma therapy |
Primary outcome
Patients with two doses of CP tended to have faster recovery than those with one dose of CP.
Time frame: 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.
1 secondary outcome
Patients with two doses of CP tended to have faster PCR negative conversion time than those with one dose of CP
Time frame: 1 April 2020 - 31 December 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- BackgroundIndonesia: WHO Coronavirus Disease (COVID-19) Dashboard | WHO Coronavirus Disease (COVID-19) Dashboard
- BackgroundOzdemir OHE. Convalescent (Immune) Plasma Therapy with all Aspects: Yesterday, Today and COVID-19. Erciyes Med J. 2020;1-8.
- BackgroundRahardjo TM, Triyono T, Harly PR. Buku Penatalaksanaan Terapi Plasma Konvalesen Bagi Pasien COVID-19 Di Indonesia. Revised Edition. September 2020.
- Results publication: PubMed 32167489Casadevall 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.
- Results publication: PubMed 32792417Focosi 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.
- Results publication: PubMed 32254064Bloch 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.
- Results publication: PubMed 32253318Duan 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.
- Results publication: PubMed 32219428Shen 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.
- Results publication: PubMed 32694043Abolghasemi 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.
- Results publication: PubMed 32934372Liu 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.
- Results publication: PubMed 33406353Libster 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.
- Results publication: PubMed 15616839Cheng 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.
- Individual participant dataSharing planned: No
Related trials for Infectious Disease
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresia M Rahardjo, Dr principal investigator
Maranatha Christian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease, run by Maranatha Christian University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with two doses of CP tended to have faster recovery than those with one dose of CP. (time frame: 1 April 2020 - 31 December 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05046652, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.