Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
2 other identifiers
interventional
30
1 country
1
Brief Summary
Coronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also significant. Therefore, finding effective treatment for the mortality of these patients is very important. In this study the investigators aim to determine the effect of Convalescent Plasma on COVID-19 patients Outcome through a Clinical Trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2020
CompletedStudy Start
First participant enrolled
March 28, 2020
CompletedFirst Posted
Study publicly available on registry
March 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedMarch 31, 2020
March 1, 2020
2 months
March 24, 2020
March 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Mortality changes in day 10
Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
10 days after plasma transmission
Mortality changes in day 30
Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
30 days after plasma transmission
Changes of C-reactive protein
Measurement of CRP
Day 1
Changes of C-reactive protein
Measurement of CRP
Day 3
Changes of C-reactive protein
Measurement of CRP
Day 7
Changes of Interleukin 6
Measurement of IL-6
Day 1
Changes of Interleukin 6
Measurement of IL-6
Day 3
Changes of Interleukin 6
Measurement of IL-6
Day 7
Changes of tumor necrosis factor-α
Measurement of TNF-α
Day 1
Changes of tumor necrosis factor-α
Measurement of TNF-α
Day 3
Changes of tumor necrosis factor-α
Measurement of TNF-α
Day 7
Changes of PaO2/FiO2 Ratio
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Day 1
Changes of PaO2/FiO2 Ratio
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Day 3
Changes of PaO2/FiO2 Ratio
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Day 7
Secondary Outcomes (43)
Changes of CD3
Day 1
Changes of CD3
Day 3
Changes of CD3
Day 7
Changes of CD4
Day 1
Changes of CD4
Day 3
- +38 more secondary outcomes
Study Arms (1)
COVID-19 Patients
OTHERInterventions
Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU
Eligibility Criteria
You may qualify if:
- Recipient:
- COVID-19 Patients
- Consent to attend the study
- Age 30 to 70 years
- Don't be intubated
- PaO2 / FiO2 is above 200 or Spo2 is greater than 85%.
- Donator:
- Complete recovery from severe COVID-19 disease and hospital discharge
- Consent to donate blood to the infected person
- Age 30 to 60 years
- Has normal CBC test results
- Negative COVID-19 RT-PCR test
You may not qualify if:
- Recipient:
- A history of hypersensitivity to blood transfusions or its products
- History of IgA deficiency
- Heart failure or any other factor that prevents the transmission of of 500 ml plasma
- Entering the intubation stage
- Donator:
- Patients infected with blood-borne viral / infectious diseases
- Underlying heart disease, low or high blood pressure, diabetes, epilepsy, and anything that may prohibit blood donation.
- Use of banned drugs for blood donation (eg, ethertinate, acitretin, aliotretinoin, isotretinoin, antiandrogens, NSAIDs, etc.)
- Use of different drugs
- Other prohibited donations based on blood transfusion standards
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imam Khomeini Hospital, Mazandaran University of Medical Sciences
Sari, Mazandaran, 4816633131, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Majid Saeedi, Ph.D.
Vice-Chancellor for Research, Mazandaran University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 24, 2020
First Posted
March 31, 2020
Study Start
March 28, 2020
Primary Completion
May 20, 2020
Study Completion
September 30, 2020
Last Updated
March 31, 2020
Record last verified: 2020-03