Study Testing Convalescent Plasma vs Best Supportive Care

Baylor Scott and White Health (BSWH)

Status and phase: Withdrawn; Phase 1

Conditions: Pneumonia, Interstitial

Treatments: Other: oxygen therapy; Biological: high-titer anti-Sars-CoV-2 plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04333251

020-123

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups, including a placebo group

convalescent plasma

Experimental group

Description:

This arm will receive convalescent plasma

Treatment:

Biological: high-titer anti-Sars-CoV-2 plasma

best supportive care

Placebo Comparator group

Description:

Oxygen therapy

Treatment:

Other: oxygen therapy