Study Summary
This trial is testing whether an experimental treatment, convalescent plasma, can help people with COVID-19. The treatment will be given to people who are hospitalized and researchers will monitor how well it works.
Eligible Conditions
- Coronavirus
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 14 days
14 days
Correlation between the NAb dose titer in the convalescent plasma and change or lack of change when comparing pre-treatment and day one NAb titers to inpatients with documented COIVD-19 infection
Number of participants with clearance of viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples
Rapid deterioration as evidenced by increase in ordinal or news score within 4 hours of transfusion
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Convalescent Plasma
12%Pneumonia
4%Infusion related reaction
2%Hypoxia
2%Dyspnea
1%Acute respiratory failure
1%Migraine
1%Fatigue
1%Dehydration
1%Vomiting
1%Flank pain
1%Pulmonary embolism
1%Dizziness
1%Chest pain
Trial Design
1 Treatment Group
Single Arm
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: Convalescent Plasma · No Placebo Group · Phase 2
Single Arm
Drug
Experimental Group · 1 Intervention: Convalescent Plasma · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
COVID-19 convalescent plasma
Not yet FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days
Who is running the clinical trial?
University of New MexicoLead Sponsor
340 Previous Clinical Trials
3,537,344 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patient (or LAR) is willing and able to provide written informed consent and comply with all protocol requirements.
You are eligible for the study if you are at least 18 years of age.
For patients unable to consent, consent by the legally authorized representative (LAR) may be obtained by phone.
You are hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing.
References
- Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3. Update in: Cochrane Database Syst Rev. 2021 May 20;5:CD013600.
- Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5:CD013600. doi: 10.1002/14651858.CD013600.pub4.
- Bradfute, Steven B, Ivy Hurwitz, Alexandra V Yingling, Chunyan Ye, Qiuying Cheng, Timothy P Noonan, Jay S Raval, et al.. 2020. “Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Antibody Titers in Convalescent Plasma and Recipients in New Mexico: An Open Treatment Study in Patients with Coronavirus Disease 2019”. The Journal of Infectious Diseases. Oxford University Press (OUP). doi:10.1093/infdis/jiaa505.
- Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3. Update in: Cochrane Database Syst Rev. 2021 May 20;5:CD013600.
- Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
- Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.
- Michelle Harkins 2020. "Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04434131.
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Conditions
Cancer Related
Treatments