| Trial registration number
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NCT04891172 |
Full text link
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04891172
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First author
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Shaukat Ali, PhD
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Contact
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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ali.shaukat@duhs.edu.pk
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Registration date
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-05-18
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Recruitment status
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Recruiting
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Study design
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Oct. 18, 2022, 12:35 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
above 18 years of age
have positive covid pcr on nasopharyngeal and/or oropharyngeal swabs
classified as severe* covid-19 according to who guideline (5l-15l of oxygen requirement on fm, nrm)
consent given by the patient or first degree relative
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Exclusion criteria
Last imported at : Oct. 18, 2022, 12:35 p.m.
Source : ClinicalTrials.gov
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critical covid-19 patients [ non-invasive ventilation (hfnc, bipap, cpap) and invasive ventilation],
pregnant females
previous allergic reaction to immunoglobulin treatment
known case of any autoimmune disorder
chronic kidney disease
known case of thromboembolic disorder
aseptic meningitis
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Number of arms
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Dow University of Health Sciences
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Inclusion age min
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Pakistan
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Type of patients
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Severe disease at enrollment
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Severity scale
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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6: Severe disease at enrollment
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Total sample size
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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310
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primary outcome
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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28 day Mortality
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Notes
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Phase 2/Phase 3
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Arms
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 634, "treatment_name": "Immunoglobulin", "treatment_type": "Immunoglobulins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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