NCT04407208

Convalescent Plasma Therapy in Patients With COVID-19

Completed Phase 1 Last updated 30 June 2020

What this trial tests

Phase 1 trial testing Convalescent plasma in Convalescence in 10 participants. Completed in 22 June 2020.

Timeline

1 May 2020

Primary endpoint
22 June 2020

22 June 2020

Quick facts

Lead sponsor	Biofarma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	10
Start date	1 May 2020
Primary completion	22 June 2020
Estimated completion	22 June 2020
Sites	1 location across Indonesia

Drugs / interventions tested

• Convalescent plasma — full drug profile →

Conditions studied

• Convalescence — all drugs for Convalescence →
• Corona Virus Infection — all drugs for Corona Virus Infection →
• Plaque — all drugs for Plaque →

Sponsor

Biofarma — full company profile →

Who can join

18 and older, any sex, with Convalescence or Corona Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
2. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
   Piechotta V, Chai KL, Valk SJ, Doree C, et al · · 2020 · cited 148× · PMID 32648959 · DOI 10.1002/14651858.cd013600.pub2
3. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
   Piechotta V, Iannizzi C, Chai KL, Valk SJ, et al · · 2021 · cited 106× · PMID 34013969 · DOI 10.1002/14651858.cd013600.pub4
4. Potential Therapeutic Options for COVID-19: Current Status, Challenges, and Future Perspectives.
   Sarkar C, Mondal M, Torequl Islam M, Martorell M, et al · · 2020 · cited 64× · PMID 33041814 · DOI 10.3389/fphar.2020.572870
5. Immunotherapeutic approaches to curtail COVID-19.
   Owji H, Negahdaripour M, Hajighahramani N. · · 2020 · cited 45× · PMID 32877828 · DOI 10.1016/j.intimp.2020.106924
6. COVID-19: An overview of the current pharmacological interventions, vaccines, and clinical trials.
   Chakraborty R, Parvez S. · · 2020 · cited 35× · PMID 32739342 · DOI 10.1016/j.bcp.2020.114184
7. An updated overview of recent advances, challenges, and clinical considerations of IL-6 signaling blockade in severe coronavirus disease 2019 (COVID-19).
   Elahi R, Karami P, Heidary AH, Esmaeilzadeh A. · · 2022 · cited 33× · PMID 35074571 · DOI 10.1016/j.intimp.2022.108536
8. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 24× · PMID 36734509 · DOI 10.1002/14651858.cd013600.pub5