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Trial - NCT04853901


Column Value
Trial registration number NCT04853901
Full text link
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04853901

First author
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Hany E Dabbous, M.D

Contact
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-04-22

Recruitment status
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : April 24, 2021, 12:31 a.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 : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: adult 18 -80 years old must have laboratory confirmed covid-19(a patient with laboratory confirmation (positive rt-pcr) of covid-19 infection, irrespective of clinical signs and symptoms according to ain shams university hospitals consensus statement on management of adult covid-19 patients. must have severe or immediately life-threatening covid-19, - severe disease is defined as: - dyspnea, - respiratory frequency ≥ 30/min, - blood oxygen saturation ≤ 93%, - partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours - life-threatening disease is defined as: - respiratory failure, - septic shock, and/or - multiple organ dysfunction or failure - must provide informed consent by patient or his/her legal guardian or professional legal representative

Exclusion criteria
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- mild to moderately affected covid 19 confirmed patients. - pregnancy, lactation. - known hepatic failure. - patient who is not likely to comply to study procedures. - creatine clearance <30 ml/min. - elevated transaminases > 5 fold uln.

Number of arms
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Ain Shams University

Inclusion age min
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Egypt

Type of patients
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

77

primary outcome
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Evaluation of viral clearance

Notes
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]