COVID-19Phase 2/3PlaSenTerNCT04873414

Convalescent Plasma as Adjunct Therapy for COVID-19

A Phase 2/3 study testing Convalescent plasma treatment in people with COVID-19, run by National Institute of Health Research and Development, Ministry of Health Republic of Indonesia at 28 sites in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: COVID-19
What is being tested?: Convalescent plasma treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 364 participants
Where: 28 sitesIndonesia
Study dates: 1 Dec 2020to 31 Dec 2021
Phase: Phase 2/3
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 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients with PCR-confirmed COVID-19
Minimal age:18 years
Agree to participate in the trial with written informed consent
Moderate or Severe COVID-19 at the time of enrollment
.
Definition of moderate disease (according to Siddiqi et al):

Show all 30Show fewer

Moderate COVID-19 is defined as disease with fever, respiratory symptoms (dry cough, chest distress, or shortness of breath after activities), and pulmonary imaging findings, and at least one of the following findings:
Abnormal coagulation parameters:
D-dimer >1 µg/mL (normal <0.5 µg/mL)
Prothrombin time (>13.6 second) or International normalized ratio (INR) ≥1.8
Thrombocyte count <100x 10^3/mL
Increased pro-inflammatory markers:
C-reactive protein (CRP) ≥26.9 mg/L
Procalcitonin ≥0.5 ng/mL,
Lymphocyte count <1.5x 10^9/L) or Neutrophil/Lymphocyte ratio (NLR) >3.3
Presence of risk factors or comorbidities:
Age >65 years
Type 1 Diabetes Mellitus or type 2 Diabetes Mellitus (with any of the following: Fasting blood glucose ≥126 mg/dl, 2-h plasma glucose ≥200 mg/dL, or random plasma glucose ≥200 mg/dL, plus HbA1C >6.5%)
Chronic kidney disease (creatinine >2.0 mg/dL) or with routine hemodialysis
Chronic liver Disease with signs of liver cirrhosis; Child-Turcotte-Pugh (CTP) Class A (score 5-6) or Class B (score 7-9) or higher; or Model for End-Stage Liver Disease (MELD) score <39
Heart failure (New York Health Association [NYHA] Class I or II)
Bronchial asthma, chronic obstructive pulmonary disease (COPD), or pulmonary tuberculosis
Cancer (particularly patients with chemotherapy or immunotherapy)
Immunocompromised conditions, including HIV/AIDS, post-organ transplantation, or judged by attending physician (preferable after specialist consultation)
Long-term corticosteroid use
autoimmune disease
Sequential Organ Failure Assessment [SOFA] score ≥5.65
Body Mass Index (BMI) ≥35 kg/m2
Definition of severe COVID-19 (according to Siddiqi et al):
Severe Covid-19 is defined as disease with a respiratory rate ≥30 breaths/min, oxygen saturation <90% or oxygenation index (PaO2/FiO2) ≤300 mmHg, and/or lung infiltrates >50% within 24-48 h.

Who cannot join

Pregnant or lactating woman
History of transfusion reaction, blood-group incompatibility, IgA deficiency, or Allergy to Immunoglobulin-containing substances
Concurrent participation of clinical trials of COVID-19 treatment
Possibility of transfer to other hospital within 72 hours
Heart Failure (NYHA Class III or higher) or other diseases with risks of volume overload
Permanent organ failure unrelated to COVID-19, including:

Show all 10Show fewer

End-stage liver disease (CTP score >10 or MELD score >40)
End stage renal disease with creatinine clearance <30% or in routine dialysis
Multiple organ failure (SOFA score ≥11)
Concomitant condition or treatment with risks of thrombosis, e.g., cryoglobulinemia, refractory hypertriglyceridemia, or monoclonal gammopathy

Trial locations and contacts

28 sites in 1 country.

Muhammad Karyana, MD, MKes contact

062816789813

mkaryana@gmail.com

Retna M Indah, MD, MPH contact

0628990222987

retnaindah.sugiyono@ina-respond.net

City, postcode or hospital

Sites recruiting now only

28 sites in 1 country

Indonesia28 sites, 27 recruiting

Aceh Tamiang Hospital
Aceh Tamiang, Special Region of Aceh, 13760
Wahyudin, MD,SpPD, wahyuddin@gmail.com
Andika Putra, MD,SpPD, andikaputra_13@yahoo.com
Recruiting
Dr. Hasan Sadikin Central Hospital
Bandung, West Java
Ruswana Anwar, OG(REI),PhD, ruswana_anwar@yahoo.com
Dimmy Prasetya, MD,SpPD-KHOM, dimmyprasetyaipd@gmail.com
Recruiting
RSD Gunung Jati
Cirebon, West Java
Agung Hujjatulislam, MD,SpAn,KIC, agung.hujjatulislam@gmail.com
Oom Nurrohmah, MD,SpPD, oomnurrohmah2@gmail.com
Recruiting
Sanglah Central Hospital
Denpasar, Bali
Ni Wayan Candrawati, MD,SpP, niwayancandrawati@gmail.com
I Ketut Agus Somia, MD,SpPD-KPTI, agus.somia@unud.ac.id
Recruiting
Udayana University Hospital
Denpasar, Bali
I Wayan Aryabiantara, MD,SpAn-KIC, aryabiantara@gmail.com
Cokorda Agung W Purnamasidhi, MD, purnamasidhi@unud.ac.id
Recruiting
Pasar Minggu Hospital
Jakarta, DKI
Mohammad Yanuar Fajar, MD,SpP, mohyanfa_dr@yahoo.co.id
Sri Rachmawati, SpAn-KIC, srirachmawati1945@gmail.com
Recruiting
dr. Cipto Mangunkusumo National Central General Hospital
Jakarta, 10430
Cleopas Martin Rumende, MD,SpPD-KP, rumende_martin@yahoo.com
Cleopas Martin Rumende, MD,SpPD-KP
Recruiting
YARSI Hospital
Jakarta, 10510
Faizal Drissa Hasibuan, SpPD-KHOM
Faizal Drissa Hasibuan, SpPD-KHOM
Not yet recruiting
Dr. Suyoto Pusrehab Kemenhan Hospital
Jakarta, 12330
Eko Martdiyanto, MD,SpP, drechom@gmail.com
Arditya Endiarsari, MD,SpPK, arditya.endiarsari@gmail.com
Recruiting
Persahabatan Central hospital
Jakarta, 13230
Sita Laksmi Andarini, MD,SpP-KP, sitaandarini@yahoo.com
Sita Laksmi Andarini, MD,SpP-KP
Not yet recruiting
Fatmawati Central Hospital
Jakarta
Martha Iskandar, MD,SpPD, marthaiskandar@gmail.com
Krishna A Wibisana, MD,SpPD, K.wibisana@gmail.com
Recruiting
Prof. Dr. Sulianti Saroso Infectious Disease Hospital
Jakarta
Herlina, MD,SpPD, herlinadr21@gmail.com
Dian Wahyu W Tanjungsari, MD,SpPK, dianwahyu@gmail.com
Recruiting
University Of Indonesia Hospital (RSUI)
Jakarta
Withdrawn
Emergency Hospital for COVID-19 - Wisma Atlet Kemayoran
Jakarta Pusat, Jakarta Special Capital Region, 14360
Efriadi Ismail, MD,SpP(K), efriadidr@gmail.com
Arief Riadi Arifin, MD,SpP(K), riadiarifin4@gmail.com
Not yet recruiting
Gatot Soebroto Central Army Hospital
Jakarta Pusat
Retno Wihastuti, MD,SpP, rwihastuti@gmail.com
Marliana S Rejeki, MD,SpFK, marliana.sr@gmail.com
Recruiting
Dr. Soeradji Tirtonegoro Hospital
Klaten, Central Java
Achmad Thabrani, MD,SpPD, thabraniachmad0@gmail.com
Zakiah Novianti, MD,SpP, zakiahnovianti.pulmonologist@gmail.com
Recruiting
Dr. Haryoto Regency Hospital
Lumajang, East Java, 67311
Halimi Maksum, MD,MMRS, halimi_maksum@yahoo.co.id
Dwi Yuliati, MD,SpP, dyparu@gmail.com
Recruiting
Dr. Tadjuddin Chalid Hospital
Makassar, Souh Sulawesi
Sitti Nursiyah, MD,SpP, ichanurisyah@gmail.com
Erwin Arief, MD,SpPD-KP, erwin.pulmo@gmail.com
Recruiting
Dr. Wahidin Sudirohusodo Central Hospital
Makassar, South Sulawesi, 90245
Faisal Muchtar, MD,SpAn-KIC, faisal_kedok@yahoo.com
Andi Adil, MD,SpAn-KAKV, adilzanetti4444@gmail.com
Recruiting
Hasanuddin University Hospital
Makassar, South Sulawesi, 90245
Haizah Nurdin, MD,SpAn-KIC, haizahnurdin.anestesi@yahoo.com
Rezki Hardiyanti, SpAn, rezkihardiyanti.taufik@gmail.com
Recruiting
Dadi Hospital
Makassar, South Sulawesi
Alamsyah AA Husain, M, alamsyah.md@gmail.com
Muhammad Iswan Wahab, MD, iswanwahab@gmail.com
Not yet recruiting
Prof. Dr. R.D. Kandou Hospital
Manado, North Sulawesi
Linda WA Rotty, SpPDKHOMProf, linda_rotty@yahoo.com
John Wantania, SpOG-K,Prof, john_w_md@yahoo.com
Recruiting
Dr. Mohammad Hoesin Central Hospital
Palembang, South Sumatra
Zen Achmad, MD,SpPD-KP, joniahmad21@yahoo.com
Nelda Aprilia Salim, MD,SpPD, apriliadoctor@gmail.com
Recruiting
Waluyo Jati Kraksaan Regency Hospital
Probolinggo, East Java, 67282
Yessi Rachmawati, MD,SpOG-K, yessirahmawati76@gmail.com
M. Reza, MD,MSc,SpA, reza.paed@gmail.com
Not yet recruiting
Dr. Wongsonegoro Regency Hospital
Semarang, Central Java, 50272
Jenny W Kandowangko, SpP, kandowangko@yahoo.com
Diana Novitasari, SpPD,KEMD, diana_budiharto@yahoo.com
Not yet recruiting
Sidoarjo Regency Hospital
Sidoarjo, East Java
Nisvi Dewi Andaningrum,,SpPD, nisvidewi22@gmail.com
Raditya Rizky Muhammad, MD, radityarizki25@gmail.com
Recruiting
Dr Ramelan Navy Hospital
Surabaya, East Java
Fransiscus OH Prasetyadi, MD,SpOG-K, fransohp@gmail.com
Sri SI Marthaty, MD,SpP, ss.indah.martha@gmail.com
Recruiting
Dr. Soetomo Hospital
Surabaya, East Java
Bambang P Semadi, MD,SpAn-KIC, bpsemedi@gmail.com
Ugroseno Y Bintoro, MD,SpPD-KHOM, ugrosenoyb2004@yahoo.com
Recruiting

Other trials in Indonesia

About this study

Official title: Clinical Trial of Convalescent Plasma Administration as Adjunct Therapy for COVID-19 (Uji Klinik Pemberian Plasma Konvalesen Sebagai Terapi Tambahan COVID-19)

Convalescent plasma (CP) has been the subject of increasing expectation for treating coronavirus disease 2019 (COVID-19). Reports on CP transfusion have shown promising clinical improvements without serious adverse events. To date, most studies focused on reporting CP treatment in patients with severe COVID-19, but only a few addressed benefits on less severe disease. The vast majority of studies reporting COVID-19 infection and treatment have come from earlier affected countries with established health systems and research infrastructure, while very few are from low- and middle-income countries (LMICs). Nonetheless, CP therapy could be one of the few available options in LMICs where constraints may exist in the access to novel treatments, even once available. Clinical trials conducted in LMICs may differ in many respects from those in high-income countries.

This study will evaluate the safety and efficacy of convalescent plasma therapy in hospitalized with moderate and severe COVID-19, to investigate the impacts of the treatment over the course of clinical illness, including non-mortal clinical outcomes.

Read the detailed description

Coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread rapidly around the world, with high rates of transmission and substantial mortality.

Convalescent plasma (CP) collected from recovered patients has been evaluated in the treatment of SARS, Middle East respiratory syndrome (MERS), and Ebola, but not well further studied and with no definitive results. Preliminary studies in COVID-19 patients showed improvement in clinical status after CP transfusion. However, a multicenter, open-label, randomized clinical trial of 103 patients in China with severe or life-threatening COVID-19 found no statistical difference in clinical improvement within 28 days among patients treated with CP versus standard treatment alone.

To date, CP has not been approved as a standard of care for COVID-19. There are insufficient data from well-controlled, adequately powered, randomized clinical trials to evaluate the efficacy and safety of CP for the treatment of this disease. One randomized controlled trial (NCT04342182) was halted for redesign based on the consideration that most COVID-19 patients already have high neutralizing antibody titers at hospital admission and no difference in mortality (p=0.95), hospital stay (p=0.68), or day-15 disease severity (p=0.58) was observed between plasma treated patients and patients on standard of care. Another clinical study (NCT04345523) showed efficacy and safety of CP in preventing progression to severe disease or death. However, this study was halted early due to low enrolment. Further studies have been published and assessed in several systematic reviews that remain uncertain about the safety and effectiveness of CP treatment for COVID-19.

The vast majority of studies reporting COVID-19 trials have come from the earlier affected countries with established healthcare systems and better research infrastructure, while very few are from low- and middle-income countries (LMICs). Meanwhile, the cases in LMICs have risen considerably with critical research questions specific to the needs of are hard to answer. As an LMIC with a geographically dispersed archipelago, access to healthcare remains a challenge in remote districts that could impact the adoption of CP deployment in Indonesia. Consequently, clinical trials conducted in LMICs may differ in many respects from those in high-income countries.

This study will evaluate the safety and efficacy of CP therapy in hospitalized with moderate and severe COVID-19, to investigate the impacts of the treatment over the course of clinical illness, including non-mortal clinical outcomes. This study will involve hospitals from different places of the Indonesian archipelago, with different characteristics and community structures, social, and values. To obtain supports for the trial, the investigators will seek community engagement that allows investigators and community leaders working collaboratively.

Conditions: COVID-19
Being tested: Convalescent plasma treatment
Keywords: COVID-19, Moderate, Severe, Convalescent Plasma, Indonesia
Medical subject headings: COVID-19, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Convalescent plasma treatmentBiological
Convalescent Plasma collected from patients who recover from COVID-19 and have been discharged from the hospital for at least 14 days.

Study groups in NCT04873414
Study group	Role	What they receive
Treatment group	Experimental	Subjects in the Treatment Group are given 200 ml of Plasma collected from Convalescent Patients recovered from COVID-19 at two-day intervals in addition to standard supportive treatment Receives: Biological: Convalescent plasma treatment
Control group	No intervention	Subjects in the Control Group are given standard supportive treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

The mortality in COVID-19 patients treated with convalescent plasma
Number of deaths from the initiation of CP treatment until hospital discharge or death.
Measured: From the initiation of CP treatment until hospital discharge or death, up to 28 days

Secondary outcomes (14)

Change in clinical status category in CP-receiving patients
Change in clinical status category will be scored daily based on the modified WHO six-point ordinal scale. The six-point scale is as follows: 1, non-hospitalized; 2, hospitalized, without supplemental oxygen; 3, hospitalized, with supplemental oxygen; 4, hospitalized, with nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; 5, hospitalized, with invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or both; and 6, death
Measured: From the initiation of CP treatment until hospital discharge or death, up to 28 days
Duration of hospitalization
Number of days from the admission to the date of discharge or death. Patients who are not discharged and remain in the hospital at the end of study period will be censored on the study's end date, while those who are lost to follow-up will be censored on the last encounter date
Measured: From admisstion until hospital discharge or death, up to 28 days
Duration of mechanical ventilation
Number of days in patients with ventilatory support
Measured: From the initiation of CP treatment until hospital discharge or death, up to 28 days
Duration of ICU stay
Number of days from entry to release from ICU
Measured: From the initiation of CP treatment until hospital discharge or death, up to 28 days
Change in lung image radiography in CP-receiving patients
The lung radiological image will be assessed using the Brixia chest X-ray scoring (Morghesi and Maroldi, 2020). Each lung is divided into three zones, marked by letters A, B, and C for the right lung, and D, E, and F for the left lung. The letters divide the lungs into three levels: upper level (A and D), above the inferior wall of the aortic arch; middle level (B and E), below the inferior wall of the aortic arch and above the inferior wall of the right inferior pulmonary vein; and lower level (C and F), below the inferior wall of the right inferior pulmonary vein. A score (from 0 to 3) is assigned to each zone based on the detected lung abnormalities: 0, no lung abnormalities; 1, interstitial infiltrates; 2, interstitial and alveolar infiltrates (interstitial pre-dominance); and 3, interstitial and alveolar infiltrates (alveolar predominance). The overall CXR score is the sum of points from the six lung zones with a range from 0 to 18.
Measured: Days 0, 6, 14, 21, and 28
Change in inflammatory parameters in CP-receiving patients
Measurement of C-reactive protein (reference: <5.0 mg/L); neutrophil/lymphocyte ratio reference range: male, 0.43~2.75; female,0.37~2.87), procalcitonin (reference: <0.15 ng/mL), and IL-6 (reference range: (5-15 pg/ml) levels in CP-receiving patients
Measured: Days 0, 6, 14, 21, and 28
Change in coagulation parameters in CP-receiving patients
Measurement of D-Dimer (reference: <0.5 mcg/mL) and prothrombin time (reference range: 11.0-13.6) seconds in CP-receiving patients
Measured: Days 0, 6, 14, 21, and 28
Change in viral load in CP-receiving patients
Measurement of viral load by nasopharyngeal swab PCR in CP-receiving patients. Additional test on day 3 will be performed to identify the early clearance of the virus.
Measured: Days 0, 3, 6, 14, 21, and 28
Changes in anti-SARS-CoV-2 antibody levels in CP-receiving patients
Plasma/serum titer of anti-SARS-CoV-2 antibodies in CP-receiving patients by the plaque reduction neutralization test or enzyme-linked immunosorbent assay. Additional test on day 3 will be performed to identify the early changes in antibody levels.
Measured: Days 0, 3, 6, 14, 21, and 28
Systemic organ involvement in patients receiving CP treatment
Systemic organ involvement measured by the Sequential Organ Failure Assessment (SOFA) score. It is used for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic), and can measure individual or aggregate organ dysfunction. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The SOFA score ranges from 0 to 24. An increasing or unchanged SOFA score is associated with a higher mortality rate than patients with a decreasing score.
Measured: Days 0, 6, 14, 21, and 28
Time to resolution of symptoms in patients receiving CP treatment
Patients whose symptoms are not resolved and remain in the hospital at the end of study period will be censored on the study's end date, while those are lost to follow-up will be censored on the last encounter date.
Measured: Days 0, 6, 14, 21, and 28
Treatment-related adverse events (AEs) and serious adverse events (SAEs)
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: From the initiation of CP treatment until hospital discharge or death, up to 28 days
Impact of anti-SARS-CoV-2 antibody levels in donors on the efficacy of CP therapy in CP-receiving patients
Correlation between anti-SARS-CoV-2 antibody levels in donors and the clinical status of CP-receiving patients according to the modified WHO 6-point ordinal scale
Measured: Days 0, 6, 14, 21, and 28
Impact of anti-SARS-CoV-2 antibody levels in donors on the viral clearance in CP-receiving patients
Correlation between anti-SARS-CoV-2 antibody levels in the donors and the viral clearance in CP-receiving patients. Additional test on day 3 will be performed to identify the early clearance of the virus.
Measured: Days 0, 3, 6, 14, 21, and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202031 Dec 2021

First posted5 May 2021
Study start1 Dec 2020
Primary completion30 Oct 2021 (estimated)
Study completion31 Dec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 364 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04873414
Sponsor's protocol ID: COVID-CT002
Acronym: PlaSenTer
Status last verified: May 2021
First submitted: 26 Apr 2021
Last updated: 2 Jun 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The original datasets used for this study are not publicly available due to the existing regulation, and only can be shared upon the approval of the Sponsor on behalf of the Ministry of Health.

Publications

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
Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.
PubMed 25030060
Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, Hu C, Tao C, Yang R, Wang J, Yu Y, Guo Y, Wu X, Xu Z, Zeng L, Xiong N, Chen L, Wang J, Man N, Liu Y, Xu H, Deng E, Zhang X, Li C, Wang C, Su S, Zhang L, Wang J, Wu Y, Liu Z. Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial. JAMA. 2020 Aug 4;324(5):460-470. doi: 10.1001/jama.2020.10044.
PubMed 32492084
Szako L, Farkas N, Kiss S, Vancsa S, Zadori N, Vorhendi N, Eross B, Hegyi P, Alizadeh H. Convalescent plasma therapy for COVID-19 patients: a protocol of a prospective meta-analysis of randomized controlled trials. Trials. 2021 Feb 1;22(1):112. doi: 10.1186/s13063-021-05066-2.
PubMed 33522939
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
Diago-Sempere E, Bueno JL, Sancho-Lopez A, Rubio EM, Torres F, de Molina RM, Fernandez-Cruz A, de Diego IS, Velasco-Iglesias A, Payares-Herrera C, Flecha IC, Avendano-Sola C, Palomino RD, Ramos-Martinez A, Ruiz-Antoran B. Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial. Trials. 2021 Jan 20;22(1):70. doi: 10.1186/s13063-020-05011-9.
PubMed 33472681
WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis. 2020 Aug;20(8):e192-e197. doi: 10.1016/S1473-3099(20)30483-7. Epub 2020 Jun 12.
PubMed 32539990
Siddiqi HK, Mehra MR. COVID-19 illness in native and immunosuppressed states: A clinical-therapeutic staging proposal. J Heart Lung Transplant. 2020 May;39(5):405-407. doi: 10.1016/j.healun.2020.03.012. Epub 2020 Mar 20. No abstract available.
PubMed 32362390
Borghesi A, Maroldi R. COVID-19 outbreak in Italy: experimental chest X-ray scoring system for quantifying and monitoring disease progression. Radiol Med. 2020 May;125(5):509-513. doi: 10.1007/s11547-020-01200-3. Epub 2020 May 1.
PubMed 32358689
Ekmekci PE, Arda B. Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights. Cultura (Iasi). 2017;14(2):159-172.
PubMed 29645014
Zulu JM, Sandoy IF, Moland KM, Musonda P, Munsaka E, Blystad A. The challenge of community engagement and informed consent in rural Zambia: an example from a pilot study. BMC Med Ethics. 2019 Jul 4;20(1):45. doi: 10.1186/s12910-019-0382-x.
PubMed 31272489
Janiaud P, Axfors C, Schmitt AM, Gloy V, Ebrahimi F, Hepprich M, Smith ER, Haber NA, Khanna N, Moher D, Goodman SN, Ioannidis JPA, Hemkens LG. Association of Convalescent Plasma Treatment With Clinical Outcomes in Patients With COVID-19: A Systematic Review and Meta-analysis. JAMA. 2021 Mar 23;325(12):1185-1195. doi: 10.1001/jama.2021.2747.
PubMed 33635310
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
Marx R, Eggert G, Beldner W. [Thermal expansion and plasticizing temperatures of dental adhesives]. Dtsch Zahnarztl Z. 1988 Apr;43(4):465-8. No abstract available. German.
PubMed 3044747
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2009 Jan;32 Suppl 1(Suppl 1):S62-7. doi: 10.2337/dc09-S062. No abstract available.
PubMed 19118289

Want to know more?

Muhammad Karyana, MD, MKes

062816789813

mkaryana@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
Active, not recruitingPhase 2
COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
Covid19
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Enrolling by invitationObservational study
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Dementia

All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial of Convalescent Plasma Administration as Adjunct Therapy for COVID-19 (Uji Klinik Pemberian Plasma Konvalesen Sebagai Terapi Tambahan COVID-19)
ClinicalTrials.gov ID: NCT04873414
Acronym / sponsor ID: PlaSenTer / COVID-CT002
Conditions: COVID-19
Keywords: COVID-19, Moderate, Severe, Convalescent Plasma, Indonesia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 364 participants (estimated)
Lead sponsor: National Institute of Health Research and Development, Ministry of Health Republic of IndonesiaUniversity, hospital or other
Collaborators: Indonesian Red Cross, Eijkman Institute for Molecular Biology
Study start: 1 Dec 2020 (actual)
Primary completion: 30 Oct 2021 (estimated)
Study completion: 31 Dec 2021 (estimated)
First posted: 5 May 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment group	Experimental	Biological: Convalescent plasma treatmentSubjects in the Treatment Group are given 200 ml of Plasma collected from Convalescent Patients recovered from COVID-19 at two-day intervals in addition to standard supportive treatment
Control group	No intervention	–Subjects in the Control Group are given standard supportive treatment

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (30 listed)

Patients with PCR-confirmed COVID-19
Minimal age:18 years
Agree to participate in the trial with written informed consent
Moderate or Severe COVID-19 at the time of enrollment
.

Key exclusion criteria (10 listed)

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 treatmentConvalescent Plasma collected from patients who recover from COVID-19 and have been discharged from the hospital for at least 14 days.	Biological	Treatment group

Primary outcome

The mortality in COVID-19 patients treated with convalescent plasma
Time frame: From the initiation of CP treatment until hospital discharge or death, up to 28 days
Number of deaths from the initiation of CP treatment until hospital discharge or death.

14 secondary outcomes

Change in clinical status category in CP-receiving patients
Time frame: From the initiation of CP treatment until hospital discharge or death, up to 28 days
Duration of hospitalization
Time frame: From admisstion until hospital discharge or death, up to 28 days
Duration of mechanical ventilation
Time frame: From the initiation of CP treatment until hospital discharge or death, up to 28 days
Duration of ICU stay
Time frame: From the initiation of CP treatment until hospital discharge or death, up to 28 days
Change in lung image radiography in CP-receiving patients
Time frame: Days 0, 6, 14, 21, and 28
Change in inflammatory parameters in CP-receiving patients
Time frame: Days 0, 6, 14, 21, and 28
Change in coagulation parameters in CP-receiving patients
Time frame: Days 0, 6, 14, 21, and 28
Change in viral load in CP-receiving patients
Time frame: Days 0, 3, 6, 14, 21, and 28
Changes in anti-SARS-CoV-2 antibody levels in CP-receiving patients
Time frame: Days 0, 3, 6, 14, 21, and 28
Systemic organ involvement in patients receiving CP treatment
Time frame: Days 0, 6, 14, 21, and 28
Time to resolution of symptoms in patients receiving CP treatment
Time frame: Days 0, 6, 14, 21, and 28
Treatment-related adverse events (AEs) and serious adverse events (SAEs)
Time frame: From the initiation of CP treatment until hospital discharge or death, up to 28 days
Impact of anti-SARS-CoV-2 antibody levels in donors on the efficacy of CP therapy in CP-receiving patients
Time frame: Days 0, 6, 14, 21, and 28
Impact of anti-SARS-CoV-2 antibody levels in donors on the viral clearance in CP-receiving patients
Time frame: Days 0, 3, 6, 14, 21, and 28

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
Background: 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.
Background: PubMed 25030060Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.
Background: PubMed 32492084Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, Hu C, Tao C, Yang R, Wang J, Yu Y, Guo Y, Wu X, Xu Z, Zeng L, Xiong N, Chen L, Wang J, Man N, Liu Y, Xu H, Deng E, Zhang X, Li C, Wang C, Su S, Zhang L, Wang J, Wu Y, Liu Z. Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial. JAMA. 2020 Aug 4;324(5):460-470. doi: 10.1001/jama.2020.10044.
Background: PubMed 33522939Szako L, Farkas N, Kiss S, Vancsa S, Zadori N, Vorhendi N, Eross B, Hegyi P, Alizadeh H. Convalescent plasma therapy for COVID-19 patients: a protocol of a prospective meta-analysis of randomized controlled trials. Trials. 2021 Feb 1;22(1):112. doi: 10.1186/s13063-021-05066-2.
Background: 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.
Background: PubMed 33472681Diago-Sempere E, Bueno JL, Sancho-Lopez A, Rubio EM, Torres F, de Molina RM, Fernandez-Cruz A, de Diego IS, Velasco-Iglesias A, Payares-Herrera C, Flecha IC, Avendano-Sola C, Palomino RD, Ramos-Martinez A, Ruiz-Antoran B. Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial. Trials. 2021 Jan 20;22(1):70. doi: 10.1186/s13063-020-05011-9.
Background: PubMed 32539990WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis. 2020 Aug;20(8):e192-e197. doi: 10.1016/S1473-3099(20)30483-7. Epub 2020 Jun 12.
Background: PubMed 32362390Siddiqi HK, Mehra MR. COVID-19 illness in native and immunosuppressed states: A clinical-therapeutic staging proposal. J Heart Lung Transplant. 2020 May;39(5):405-407. doi: 10.1016/j.healun.2020.03.012. Epub 2020 Mar 20. No abstract available.
Background: PubMed 32358689Borghesi A, Maroldi R. COVID-19 outbreak in Italy: experimental chest X-ray scoring system for quantifying and monitoring disease progression. Radiol Med. 2020 May;125(5):509-513. doi: 10.1007/s11547-020-01200-3. Epub 2020 May 1.
Background: PubMed 29645014Ekmekci PE, Arda B. Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights. Cultura (Iasi). 2017;14(2):159-172.
Background: PubMed 31272489Zulu JM, Sandoy IF, Moland KM, Musonda P, Munsaka E, Blystad A. The challenge of community engagement and informed consent in rural Zambia: an example from a pilot study. BMC Med Ethics. 2019 Jul 4;20(1):45. doi: 10.1186/s12910-019-0382-x.
Background: PubMed 33635310Janiaud P, Axfors C, Schmitt AM, Gloy V, Ebrahimi F, Hepprich M, Smith ER, Haber NA, Khanna N, Moher D, Goodman SN, Ioannidis JPA, Hemkens LG. Association of Convalescent Plasma Treatment With Clinical Outcomes in Patients With COVID-19: A Systematic Review and Meta-analysis. JAMA. 2021 Mar 23;325(12):1185-1195. doi: 10.1001/jama.2021.2747.
Convalescent Plasma for COVID-19. A randomized clinical trialLink provided by the sponsor.
Clinical management of COVID-19: Interim guidanceLink provided by the sponsor.
NCI Common Terminology Criteria for Adverse Events (CTCAE)Link provided by the sponsor.
Individual participant dataSharing planned: Yes. The original datasets used for this study are not publicly available due to the existing regulation, and only can be shared upon the approval of the Sponsor on behalf of the Ministry of Health.

Related trials for COVID-19

RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
Active, not recruitingPhase 2
COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
Covid19
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Enrolling by invitationObservational study
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Dementia

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.

Muhammad Karyana, MD, MKes contact

062816789813

mkaryana@gmail.com

Retna M Indah, MD, MPH contact

0628990222987

retnaindah.sugiyono@ina-respond.net

David H Muljono, MD, PhD. principal investigator

Eijkman Institute for Molecular Biology

Irmansyah, MD, PhD principal investigator

National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Sri Idaiani, MD, PhD study director

National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 30 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Muhammad Karyana, MD, MKes (062816789813, mkaryana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The mortality in COVID-19 patients treated with convalescent plasma (time frame: From the initiation of CP treatment until hospital discharge or death, up to 28 days). 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 NCT04873414, which also lists 20 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 2 Jun 2021.