Study Testing Convalescent Plasma vs Best Supportive Care

Pneumonia, Interstitial Clinical Trial

Official title:

Evaluating Convalescent Plasma to Decrease Coronavirus Associated Complications. A Phase I Study Comparing the Efficacy and Safety of High-titer Anti-Sars-CoV-2 Plasma vs Best Supportive Care in Hospitalized Patients With Interstitial Pneumonia Due to COVID-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04333251
• Other study ID #: 020-123
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2020
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently there are no proven treatment option for COVID-19. Human convalescent plasma is an option for COVID-19 treatment and could be available from people who have recovered and can donate plasma.

Description:

Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1 shows that convalescent plasma contains neutralizing antibodies to the relevant virus. In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy would mediate protection is viral neutralization. The only antibody type that is currently available for immediate use is that found in human convalescent plasma. As more individuals contract COVID-19 and recover, the number of potential donors will continue to increase. The investigators seek to treat participants who are sick enough to warrant hospitalization prior to the onset of overwhelming disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 115
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria Donor:

• 18 years or older

• must have been hospitalized w/COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing but are now PCR negative by 2 nasopharyngeal testing

• females of child-bearing potential must have a negative serum pregnancy test

• subject and/or LAR willing to provide informed consent

• patient agrees to storage of specimens for future testing

Inclusion Criteria Recipient:

• 18 years or older

• must have been hospitalized w/COVID-19 respiratory symptoms within 3 to 7 days from the beginning of illness

• subject and/or LAR willing to provide informed consent

• patient agrees to storage of specimens for future testing

Exclusion Criteria:

• 18 years or older

• receipt of pooled immunoglobulin in past 30 days

• contraindication to transfusion or history of prior reactions to transfusion blood products

• females who are identified as donors must not be pregnant

Related Conditions & MeSH terms

• Lung Diseases, Interstitial
• Pneumonia
• Pneumonia, Interstitial

Intervention

Biological:
• high-titer anti-Sars-CoV-2 plasma
Recipients will receive 1-2 units of ABO matched donor plasma at neutralization antibody titer >1:64 vs best supportive care

Other:
• oxygen therapy
oxygen therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in oxygen and ventilation support	reduction in oxygen and ventilation support	through study completion, an average of 4 weeks