v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT04438057 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
nvanhise@midcusa.com |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-06-18 |
|
Recruitment status
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - laboratory confirmed diagnosis of infection with sars-cov-2 - symptoms of covid -19 - cough, fever, sore throat, sob, anosmia, diarrhea, myalgia - symptoms less than 14 days - id physician determination that the patient does not need hospitalization - o2 saturation of >93% - informed consent provided by the patient or healthcare proxy - age ≥ 18 years - ambulatory outpatient when informed consent obtained and study drug is administered |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- age < 18 y/o - patients currently receiving intravenous immunoglobulin - hypercoagulable state - neoplasia, collagen vascular disease, myelodysplastic syndrome, chronic anticoagulation treatment, etc. - need to be hospitalized - o2 sat < 93% - d-dimer > 2x normal - chronic oxygen therapy - renal insufficiency with creatinine clearance < 30 - long term care or assisted living facility resident - ongoing usage of hydroxychloroquine for any indication - history of blood or plasma transfusion related complications - enrollment into any other investigational drug or device study within the previous 30 days - any drug, chemical or alcohol dependency as determined by the investigator through history that may affect study procedures and follow up - pregnant or breast feeding - any acute or chronic medical comorbidity, psychiatric, social or other circumstance that, in the opinion of the investigator, may interfere with study compliance, completion, or accurate assessment of the study outcomes/safety - admitted to or expected to be admitted to a medical facility |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Metro Infectious Disease Consultants |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
|
Total sample size
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
103 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
SAEs within 24 hours of plasma infusion;Time to Resolution of Symptoms |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |