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Study Testing Convalescent Plasma vs Best Supportive Care

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ClinicalTrials.gov Identifier: NCT04333251
Recruitment Status : Not yet recruiting
First Posted : April 3, 2020
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

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
Pneumonia, Interstitial 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. reduction in oxygen and ventilation support [ Time Frame: through study completion, an average of 4 weeks ]
    reduction in oxygen and ventilation support



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT04333251    
Other Study ID Numbers: 020-123
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020

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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:
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Pneumonia
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections