Convalescent Plasma as Adjunct Therapy for COVID-19 (PlaSenTer)

May 31, 2021 updated by: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

364

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 10430
        • Recruiting
        • Dr. Cipto Mangunkusumo National Central General Hospital
        • Contact:
        • Principal Investigator:
          • Cleopas Martin Rumende, MD,SpPD-KP
        • Sub-Investigator:
          • Lugyanti Sukrisman, MD,SpPD,KHOM
        • Sub-Investigator:
          • Nova Sri Hartati, MD,MGizi
      • Jakarta, Indonesia, 10510
        • Not yet recruiting
        • YARSI Hospital
        • Contact:
          • Faizal Drissa Hasibuan, SpPD-KHOM
        • Principal Investigator:
          • Faizal Drissa Hasibuan, SpPD-KHOM
        • Sub-Investigator:
          • Rika Bur, SpPD-KPTI
        • Sub-Investigator:
          • Annisa Rizky Afrilia, MD
      • Jakarta, Indonesia, 12330
        • Recruiting
        • Dr. Suyoto Pusrehab Kemenhan Hospital
        • Sub-Investigator:
          • Annisa Rizky Afrilia, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eko Martdiyanto, MD,SpP
        • Sub-Investigator:
          • Arditya Endiarsari, MD,SpPK
      • Jakarta, Indonesia, 13230
        • Not yet recruiting
        • Persahabatan Central hospital
        • Sub-Investigator:
          • Lelly Andayasari, drg,MKes
        • Contact:
        • Principal Investigator:
          • Sita Laksmi Andarini, MD,SpP-KP
        • Sub-Investigator:
          • Hayatun Nufus, MD,SpPD
      • Jakarta, Indonesia
        • Recruiting
        • Fatmawati Central Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martha Iskandar, MD,SpPD
        • Sub-Investigator:
          • Krishna A Wibisana, MD,SpPD
        • Sub-Investigator:
          • Aprildah, MD
      • Jakarta, Indonesia
        • Recruiting
        • Prof. Dr. Sulianti Saroso Infectious Disease Hospital
        • Sub-Investigator:
          • Sundari Wirasmi, SSi
        • Contact:
        • Contact:
        • Principal Investigator:
          • Herlina, MD,SpPD
        • Sub-Investigator:
          • Dian Wahyu Tanjungsari, MD,SpPK
      • Jakarta, Indonesia
        • Withdrawn
        • University of Indonesia Hospital (RSUI)
      • Jakarta Pusat, Indonesia
        • Recruiting
        • Gatot Soebroto Central Army Hospital
        • Sub-Investigator:
          • Made A Lely Suratri, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Retno Wihastuti, MD,SpP
        • Sub-Investigator:
          • Marliana S Rejeki, MD,SpFK
    • Aceh
      • Aceh Tamiang, Aceh, Indonesia, 13760
        • Recruiting
        • Aceh Tamiang Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wahyudin, MD,SpPD
        • Sub-Investigator:
          • Andika Putra, MD,SpPD
        • Sub-Investigator:
          • Hadjar Siswantoro, MD,MPH
    • Bali
      • Denpasar, Bali, Indonesia
        • Recruiting
        • Sanglah Central Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ni Wayan Candrawati, MD,SpP
        • Sub-Investigator:
          • I Ketut Agus Somia, MD,SpPD-KPTI
        • Sub-Investigator:
          • Widianto Pancaharjono, MD
      • Denpasar, Bali, Indonesia
        • Recruiting
        • Udayana University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • I Wayan Aryabiantara, MD,SpAn-KIC
        • Sub-Investigator:
          • Cokorda Agung W Purnamasidhi, MD
        • Sub-Investigator:
          • Made A Lely Suratri, MD
    • Central Java
      • Klaten, Central Java, Indonesia
        • Recruiting
        • Dr. Soeradji Tirtonegoro Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Achmad Thabrani, MD,SpPD
        • Sub-Investigator:
          • Zakiah Novianti, MD,SpP
        • Sub-Investigator:
          • Tince Jovina, drg,MKM
      • Semarang, Central Java, Indonesia, 50272
        • Not yet recruiting
        • Dr. Wongsonegoro Regency Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jenny W Kandowangko, SpP
        • Sub-Investigator:
          • Diana Novitasari, SpPD-KEMD
        • Sub-Investigator:
          • Lelly Andayasari, drg,MKes
    • DKI
      • Jakarta, DKI, Indonesia
        • Recruiting
        • Pasar Minggu Hospital
        • Sub-Investigator:
          • Lelly Andayasari, drg,MKes
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohammad Yanuar Fajar, MD,SpP
        • Sub-Investigator:
          • Sri Rachmawati, MD,SpAn-KIC
    • East Java
      • Lumajang, East Java, Indonesia, 67311
        • Recruiting
        • Dr. Haryoto Regency Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Halimi Maksum, MD,MMRS
        • Sub-Investigator:
          • Dwi Yuliati, MD,SpP
        • Sub-Investigator:
          • Lusitawati, MSi
      • Probolinggo, East Java, Indonesia, 67282
        • Not yet recruiting
        • Waluyo Jati Kraksaan Regency Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yessi Rachmawati, MD,SpOG-K
        • Sub-Investigator:
          • M. Reza, MD,MSc,SpA
        • Sub-Investigator:
          • Arvina Silalahi
      • Sidoarjo, East Java, Indonesia
        • Recruiting
        • Sidoarjo Regency Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nisvi Dewi Andaningrum, MD,SpPD
        • Sub-Investigator:
          • Raditya Rizky Muhammad, MD
        • Sub-Investigator:
          • Lutfah Rif'ati, MD,PhD
      • Surabaya, East Java, Indonesia
        • Recruiting
        • Dr Ramelan Navy Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fransiscus OH Prasetyadi, MD,SpOG-K
        • Sub-Investigator:
          • Sri SI Marthaty, MD,SpP
        • Sub-Investigator:
          • Sri M Nugraha, MD
      • Surabaya, East Java, Indonesia
        • Recruiting
        • Dr. Soetomo Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bambang P Semadi, MD,SpAn-KIC
        • Sub-Investigator:
          • Ugroseno Y Bintoro, MD,SpPD-KHOM
        • Sub-Investigator:
          • Danny Fajar Mogsa, MD
    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 14360
        • Not yet recruiting
        • Emergency Hospital for COVID-19 - Wisma Atlet Kemayoran
        • Contact:
        • Contact:
        • Principal Investigator:
          • Efriadi Ismail, SpP(K)
        • Sub-Investigator:
          • Arief Riadi Arifin, SpP(K)
        • Sub-Investigator:
          • Tince Arniati Jovina, drg,MKM
    • North Sulawesi
      • Manado, North Sulawesi, Indonesia
        • Recruiting
        • Prof. Dr. R.D. Kandou Hospital
        • Sub-Investigator:
          • Danny Fajar Mogsa, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Linda Rotty, SpPDKHOMProf
        • Sub-Investigator:
          • John Wantania, SpOG-K,Prof
    • Souh Sulawesi
      • Makassar, Souh Sulawesi, Indonesia
        • Recruiting
        • Dr. Tadjuddin Chalid Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sitti Nursiyah, MD,SpP
        • Sub-Investigator:
          • Erwin Arief, MD,SpPD-KP
        • Sub-Investigator:
          • Tince Jovina, Drg, MKM
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 90245
        • Recruiting
        • Dr. Wahidin Sudirohusodo Central Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Faisal Muchtar, MD,SpAn-KIC
        • Sub-Investigator:
          • Andi Adil, MD,SpAn-KAKV
        • Sub-Investigator:
          • Sundari Wirasmi, SSi
      • Makassar, South Sulawesi, Indonesia, 90245
        • Recruiting
        • Hasanuddin University Hospital
        • Sub-Investigator:
          • Lusitawati, MSi
        • Contact:
        • Contact:
        • Principal Investigator:
          • Haizah Nurdin, MD,SpAn-KIC
        • Sub-Investigator:
          • Rezki Hardiyanti, SpAn
      • Makassar, South Sulawesi, Indonesia
        • Not yet recruiting
        • Dadi Hospital
        • Sub-Investigator:
          • Arvina Silalahi
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alamsyah AA Husain, MD
        • Sub-Investigator:
          • Muhammad Iswan Wahab, MD
    • South Sumatra
      • Palembang, South Sumatra, Indonesia
        • Recruiting
        • Dr. Mohammad Hoesin Central Hospital
        • Sub-Investigator:
          • Widianto Pancaharjono, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zen Achmad, MD,SpPD-KP
        • Sub-Investigator:
          • Nelda Aprilia Salim, MD,SpPD
    • West Java
      • Bandung, West Java, Indonesia
        • Recruiting
        • Dr. Hasan Sadikin Central Hospital
        • Sub-Investigator:
          • Lutfah Rif'ati, MD,PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruswana Anwar, OG(REI),PhD
        • Sub-Investigator:
          • Dimmy Prasetya, MD,SpPD-KHOM
      • Cirebon, West Java, Indonesia
        • Recruiting
        • RSD Gunung Jati
        • Contact:
        • Contact:
        • Principal Investigator:
          • Agung Hujjatulislam, MD,SpAn,KIC
        • Sub-Investigator:
          • Oom Nurrohmah, MD,SpPD
        • Sub-Investigator:
          • Christa G. Manik, SKep,NS,MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

  1. Patients with PCR-confirmed COVID-19
  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:

    • 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:

      • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Biological: 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.
No Intervention: Control group
Subjects in the Control Group are given standard supportive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the initiation of CP treatment until hospital discharge or death, up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
Number of days in patients with ventilatory support
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
Number of days from entry to release from ICU
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
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.
Days 0, 6, 14, 21, and 28
Change in inflammatory parameters in CP-receiving patients
Time Frame: Days 0, 6, 14, 21, and 28
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
Days 0, 6, 14, 21, and 28
Change in coagulation parameters in CP-receiving patients
Time Frame: Days 0, 6, 14, 21, and 28
Measurement of D-Dimer (reference: <0.5 mcg/mL) and prothrombin time (reference range: 11.0-13.6) seconds in CP-receiving patients
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
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.
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
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.
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
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.
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
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.
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
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
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
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
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
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.
Days 0, 3, 6, 14, 21, and 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Eijkman Institute for Molecular Biology
Indonesian Red Cross

Investigators

  • Principal Investigator: David H Muljono, MD, PhD., Eijkman Institute for Molecular Biology
  • Principal Investigator: Irmansyah, MD, PhD, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
  • Study Director: Sri Idaiani, MD, PhD, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
  • Study Director: Tetra Fajarwati, MD,PhD, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 31, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-CT002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

January 1 - December 31, 2021

IPD Sharing Access Criteria

The study protocol and and raw data are only shared to the ClinicalTrials.gov and/or Journal Reviewers.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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