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Study Testing Convalescent Plasma vs Best Supportive Care

Sponsor
Baylor Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04333251
Collaborator
(none)
115
Enrollment
2
Arms
33
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: high-titer anti-Sars-CoV-2 plasma
  • Other: oxygen therapy
 Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
115 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: convalescent plasma

This arm will receive convalescent plasma

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
Placebo Comparator: best supportive care

Oxygen therapy

Other: oxygen therapy
oxygen therapy

Outcome Measures

Primary Outcome Measures

  1. reduction in oxygen and ventilation support [through study completion, an average of 4 weeks]

    reduction in oxygen and ventilation support

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Baylor Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT04333251
Other Study ID Numbers:
  • 020-123
First Posted:
Apr 3, 2020
Last Update Posted:
Apr 6, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Pneumonia
Lung Diseases, Interstitial

Study Results

No Results Posted as of Apr 6, 2020