Study Results
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Basic Information
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UNKNOWN
PHASE2/PHASE3
364 participants
INTERVENTIONAL
2020-12-01
2021-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment group
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
Convalescent plasma treatment
Convalescent Plasma collected from patients who recover from COVID-19 and have been discharged from the hospital for at least 14 days.
Control group
Subjects in the Control Group are given standard supportive treatment
No interventions assigned to this group
Interventions
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Convalescent plasma treatment
Convalescent Plasma collected from patients who recover from COVID-19 and have been discharged from the hospital for at least 14 days.
Eligibility Criteria
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Inclusion Criteria
2. Minimal age:18 years
3. Agree to participate in the trial with written informed consent
4. Moderate or Severe COVID-19 at the time of enrollment
.
A. Definition of moderate disease (according to Siddiqi et al):
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:
i) 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
ii) 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
iii) 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
B. 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.
Exclusion Criteria
* 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:
* 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
18 Years
60 Years
ALL
No
Sponsors
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Indonesian Red Cross
UNKNOWN
Eijkman Institute for Molecular Biology
OTHER
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
OTHER
Responsible Party
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Principal Investigators
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David H Muljono, MD, PhD.
Role: PRINCIPAL_INVESTIGATOR
Eijkman Institute for Molecular Biology
Irmansyah, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Sri Idaiani, MD, PhD
Role: STUDY_DIRECTOR
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Tetra Fajarwati, MD,PhD
Role: STUDY_DIRECTOR
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Locations
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Sanglah Central Hospital
Denpasar, Bali, Indonesia
Udayana University Hospital
Denpasar, Bali, Indonesia
Dr. Soeradji Tirtonegoro Hospital
Klaten, Central Java, Indonesia
Dr. Wongsonegoro Regency Hospital
Semarang, Central Java, Indonesia
Pasar Minggu Hospital
Jakarta, DKI, Indonesia
Dr. Haryoto Regency Hospital
Lumajang, East Java, Indonesia
Waluyo Jati Kraksaan Regency Hospital
Probolinggo, East Java, Indonesia
Sidoarjo Regency Hospital
Sidoarjo, East Java, Indonesia
Dr Ramelan Navy Hospital
Surabaya, East Java, Indonesia
Dr. Soetomo Hospital
Surabaya, East Java, Indonesia
Emergency Hospital for COVID-19 - Wisma Atlet Kemayoran
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Prof. Dr. R.D. Kandou Hospital
Manado, North Sulawesi, Indonesia
Dr. Tadjuddin Chalid Hospital
Makassar, Souh Sulawesi, Indonesia
Dr. Wahidin Sudirohusodo Central Hospital
Makassar, South Sulawesi, Indonesia
Hasanuddin University Hospital
Makassar, South Sulawesi, Indonesia
Dadi Hospital
Makassar, South Sulawesi, Indonesia
Dr. Mohammad Hoesin Central Hospital
Palembang, South Sumatra, Indonesia
Aceh Tamiang Hospital
Aceh Tamiang, Special Region of Aceh, Indonesia
Dr. Hasan Sadikin Central Hospital
Bandung, West Java, Indonesia
RSD Gunung Jati
Cirebon, West Java, Indonesia
dr. Cipto Mangunkusumo National Central General Hospital
Jakarta, , Indonesia
YARSI Hospital
Jakarta, , Indonesia
Dr. Suyoto Pusrehab Kemenhan Hospital
Jakarta, , Indonesia
Persahabatan Central hospital
Jakarta, , Indonesia
Fatmawati Central Hospital
Jakarta, , Indonesia
Prof. Dr. Sulianti Saroso Infectious Disease Hospital
Jakarta, , Indonesia
University Of Indonesia Hospital (RSUI)
Jakarta, , Indonesia
Gatot Soebroto Central Army Hospital
Jakarta Pusat, , Indonesia
Countries
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Central Contacts
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Facility Contacts
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Faizal Drissa Hasibuan, SpPD-KHOM
Role: primary
References
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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.
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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.
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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.
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.
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.
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Related Links
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Convalescent Plasma for COVID-19. A randomized clinical trial
Clinical management of COVID-19: Interim guidance
NCI Common Terminology Criteria for Adverse Events (CTCAE)
Other Identifiers
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COVID-CT002
Identifier Type: -
Identifier Source: org_study_id
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