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Trial - NCT04521309


Column Value
Trial registration number NCT04521309
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04521309

First author
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Shaukat Ali, PhD

Contact
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

ali.shaukat@duhs.edu.pk

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-08-20

Recruitment status
Last imported at : Feb. 16, 2021, 12:31 a.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

Sequential assignment

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind 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: - above 18 years of age - have positive sars-cov-2 pcr on nasopharyngeal and/or oropharyngeal swabs - admitted in isolation ward and icu of institutes affiliated with duhs - have severe or critical covid 19 as judged by the treating physician - consent given by the patient or first degree relative

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- pregnancy - previous allergic reaction to immunoglobulin treatment - ig a deficiency - patient requiring 2 inotropic agents to maintain blood pressures - known case of any autoimmune disorder - acute kidney injury or chronic renal failure - known case of thromboembolic disorder - aseptic meningitis

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

5

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Dow University of Health Sciences

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

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Pakistan

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

50

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Requirement of supplemental oxygen support;28 Days mortality;Change in neutrophil lymphocyte ratio;Adverse events during hospital stay;Days to Hospital Discharge;Change in C-Reactive Protein (CRP) levels;Days to step down;Number of days on assisted ventilation

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 1/Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "0.20 g/kg", "treatment_id": 1151, "treatment_name": "Sars-cov-2 antibody based ivig therapy", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "0.25 g/kg", "treatment_id": 1151, "treatment_name": "Sars-cov-2 antibody based ivig therapy", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "0.30 g/kg", "treatment_id": 1151, "treatment_name": "Sars-cov-2 antibody based ivig therapy", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "0.35 g/kg", "treatment_id": 1151, "treatment_name": "Sars-cov-2 antibody based ivig therapy", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]