Convalescent Plasma as Adjunct Therapy for COVID-19

NCT04873414 | Unknown Phase 2 DMC

• 1 other identifier: COVID-CT002
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 28

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID-19; Moderate; Severe; Convalescent Plasma; Indonesia

Outcome Measures

Primary Outcomes (1)

• The mortality in COVID-19 patients treated with convalescent plasma

  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 Outcomes (14)

• Change in clinical status category in CP-receiving patients

  From the initiation of CP treatment until hospital discharge or death, up to 28 days

• Duration of hospitalization

  From admisstion until hospital discharge or death, up to 28 days

• Duration of mechanical ventilation

  From the initiation of CP treatment until hospital discharge or death, up to 28 days

• Duration of ICU stay

  From the initiation of CP treatment until hospital discharge or death, up to 28 days

• Change in lung image radiography in CP-receiving patients

  Days 0, 6, 14, 21, and 28

Study Arms (2)

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

Biological: Convalescent plasma treatment

Control group

NO INTERVENTION

Subjects in the Control Group are given standard supportive treatment

Interventions

Convalescent plasma treatment BIOLOGICAL

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

Treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia: lead
• Indonesian Red Cross: collaborator
• Eijkman Institute for Molecular Biology: collaborator

Study Sites (28)

Sanglah Central Hospital

Denpasar, Bali, Indonesia

RECRUITING

Udayana University Hospital

Denpasar, Bali, Indonesia

RECRUITING

Dr. Soeradji Tirtonegoro Hospital

Klaten, Central Java, Indonesia

RECRUITING

Dr. Wongsonegoro Regency Hospital

Semarang, Central Java, 50272, Indonesia

NOT YET RECRUITING

Pasar Minggu Hospital

Jakarta, DKI, Indonesia

RECRUITING

Dr. Haryoto Regency Hospital

Lumajang, East Java, 67311, Indonesia

RECRUITING

Waluyo Jati Kraksaan Regency Hospital

Probolinggo, East Java, 67282, Indonesia

NOT YET RECRUITING

Sidoarjo Regency Hospital

Sidoarjo, East Java, Indonesia

RECRUITING

Dr Ramelan Navy Hospital

Surabaya, East Java, Indonesia

RECRUITING

Dr. Soetomo Hospital

Surabaya, East Java, Indonesia

RECRUITING

Emergency Hospital for COVID-19 - Wisma Atlet Kemayoran

Jakarta Pusat, Jakarta Special Capital Region, 14360, Indonesia

NOT YET RECRUITING

Prof. Dr. R.D. Kandou Hospital

Manado, North Sulawesi, Indonesia

RECRUITING

Dr. Tadjuddin Chalid Hospital

Makassar, Souh Sulawesi, Indonesia

RECRUITING

Dr. Wahidin Sudirohusodo Central Hospital

Makassar, South Sulawesi, 90245, Indonesia

RECRUITING

Hasanuddin University Hospital

Makassar, South Sulawesi, 90245, Indonesia

RECRUITING

Dadi Hospital

Makassar, South Sulawesi, Indonesia

NOT YET RECRUITING

Dr. Mohammad Hoesin Central Hospital

Palembang, South Sumatra, Indonesia

RECRUITING

Aceh Tamiang Hospital

Aceh Tamiang, Special Region of Aceh, 13760, Indonesia

RECRUITING

Dr. Hasan Sadikin Central Hospital

Bandung, West Java, Indonesia

RECRUITING

RSD Gunung Jati

Cirebon, West Java, Indonesia

RECRUITING

dr. Cipto Mangunkusumo National Central General Hospital

Jakarta, 10430, Indonesia

RECRUITING

YARSI Hospital

Jakarta, 10510, Indonesia

NOT YET RECRUITING

Dr. Suyoto Pusrehab Kemenhan Hospital

Jakarta, 12330, Indonesia

RECRUITING

Persahabatan Central hospital

Jakarta, 13230, Indonesia

NOT YET RECRUITING

Fatmawati Central Hospital

Jakarta, Indonesia

RECRUITING

Prof. Dr. Sulianti Saroso Infectious Disease Hospital

Jakarta, Indonesia

RECRUITING

University Of Indonesia Hospital (RSUI)

Jakarta, Indonesia

WITHDRAWN

Gatot Soebroto Central Army Hospital

Jakarta Pusat, Indonesia

RECRUITING

Related Publications (20)

• Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.

  PMID: 32167489 BACKGROUND

• 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.

  PMID: 25030060 BACKGROUND

• 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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• 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.

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Related Links

• Convalescent Plasma for COVID-19. A randomized clinical trial
• Clinical management of COVID-19: Interim guidance
• NCI Common Terminology Criteria for Adverse Events (CTCAE)

MeSH Terms

Conditions

COVID-19; Lymphoma, Follicular

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

Muhammad Karyana, MD, MKes

CONTACT

062816789813; mkaryana@gmail.com

Retna M Indah, MD, MPH

CONTACT

0628990222987; retnaindah.sugiyono@ina-respond.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 5, 2021
• Study Start: December 1, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 31, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: January 1 - December 31, 2021
• Access Criteria: The study protocol and and raw data are only shared to the ClinicalTrials.gov and/or Journal Reviewers.

Locations

ID (28)