Convalescent Plasma Therapy in Patients With COVID-19

NCT04407208 | Completed Phase 1 DMC

• 1 other identifier: 3471041S322342020040800002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Scientists and medical workers all around the world were running out of time to manage COVID-19. Several studies have been done to understand the disease and ultimately to find possible treatment. Based on those studies, one of the potential treatment was antibody transfer from recovered COVID-19 patients. Passive antibody transfer was a fast and easy choice. The rational use of antibody from the patient's plasma is a natural neutralizing protein to the cell-infected virus and could possibly slow the active infection down. Investigators initiate an intervention study with purposes to produce quality convalescent plasma from the recovered patients, define the safety of plasma for human use and as an alternative treatment to improve the clinical outcomes of severe COVID-19 patients. The study hypothesis is convalescent plasma is safe and could possibly improve outcome of severe (non-critical) COVID-19 patients. This research will conduct the plaque reduction neutralizing test (PRNT) of recipient blood in vitro. The plasma will be collected in the blood transfusion unit (BTU) in Gatot Soebroto hospital. The storage, testing, transfer, and transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU. PRNT and plasma antibody titer measurement from donor plasma will be conducted at Eijkman Institute of Molecular Biology. Investigators enroll approximately 10 patients consecutively, who will be admitted at Gatot Soebroto hospital. Baseline demographic characteristics of samples are recorded. Clinical dan laboratory data will be measured before and after plasma transfusion periodically. The measured variables are pharmacological therapy (antivirus, antibiotics, steroids), invasive oxygen therapy, oxygen index, sequential organ failure assessment (SOFA) score, and laboratory parameters such as leukocyte count, blood chemical panel include liver and renal function, C-reactive protein, procalcitonin, IL-6 and immunoglobulin titer of the recipient and also chest X-ray evaluation. The potential expected risk of plasma transfusions is transfusion reaction (immunological or non-immune related) and transferred foreign pathogen. Investigator will report and treat all adverse events after plasma transfusion has been done. A severe adverse event (SAE) will also report in a special form to sponsor and data safety monitoring board (DSMB). There is theoretically antibody-dependent enhancement (ADE) mechanism from COVID-19 whom will receive plasma transfusion to progress to severe immune response. This preliminary study is supposed to provide supporting data and experience of plasma processing to a larger study in the near future.

Conditions

Convalescence; Corona Virus Infection; Plaque

Keywords

COVID-19; convalescent plasma; treatment; severe ill

Outcome Measures

Primary Outcomes (6)

• Plaque reduction neutralization test (PNRT)

  PNRT50

  day 7 after first transfusion

• D-dimer

  Change of D-dimer compared between pre and post transfusion

  day 1,4,7,14 after first transfusion

• C-Reactive Protein (CRP)

  Change of CRP compared between pre and post transfusion

  day 1,4,7,14 after first transfusion

• International Normalized Ratio (INR)

  Change of INR compared between pre and post transfusion

  day 1,4,7,14 after first transfusion

• Oxygenation Index

  Change of OI compared between pre and post transfusion

  day 1,4,7,14 after first transfusion

• Chest X-ray

  Change of CXR with CXR covid score compared between pre and post transfusion

  day 1,4,7,28 after first transfusion

Secondary Outcomes (1)

• severe adverse event

  from day 0 to 14 days after plasma transfusion

Study Arms (1)

Convalescent plasma recipient

EXPERIMENTAL

Recipients receive 3 times of each 100 ml convalescent plasma on day 0, 3, and 6

Biological: Convalescent plasma

Interventions

Convalescent plasma BIOLOGICAL

The minimum titer of specific antibody is 1/80

Convalescent plasma recipient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed COVID-19 case with RT-PCR
• Stage IIb of COVID-19 or higher
• Consent was given by the patient or legal guardian

You may not qualify if:

• Pregnant
• History of anaphylactic reaction in previous blood product transfusion

Sponsors & Collaborators

• Biofarma: lead
• Rumah Sakit Pusat Angkatan Darat Gatot Soebroto: collaborator
• Eijkman Institute for Molecular Biology: collaborator

Study Sites (1)

Gatot Soebroto central army presidential hospital

Jakarta Pusat, 10410, Indonesia

Location

Related Publications (1)

• Rejeki MS, Sarnadi N, Wihastuti R, Fazharyasti V, Samin WY, Yudhaputri FA, Johar E, Nurainy N, Bachtiar NS, Muljono DH. Convalescent plasma therapy in patients with moderate-to-severe COVID-19: A study from Indonesia for clinical research in low- and middle-income countries. EClinicalMedicine. 2021 Jun;36:100931. doi: 10.1016/j.eclinm.2021.100931. Epub 2021 Jun 4.

  PMID: 34104878 DERIVED

MeSH Terms

Conditions

Convalescence; Coronavirus Infections; Plaque, Amyloid; COVID-19

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pathological Conditions, Anatomical; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nana Sarnadi, Sp.OG

  director of research and develpment

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, clinical pharmacologist

Model Details: single-arm, pre, and post-test dependent group

Study Record Dates

• First Submitted: May 16, 2020
• First Posted: May 29, 2020
• Study Start: May 1, 2020
• Primary Completion: June 22, 2020
• Study Completion: June 22, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)