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Trial - NCT05911022


Column Value
Trial registration number NCT05911022
Full text link
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05911022

First author
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

None

Contact
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

None

Registration date
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

2023-06-20

Recruitment status
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : June 24, 2023, midnight
Source : ClinicalTrials.gov

inclusion criteria: participants aged (18-60) years with confirmed criteria of covid-19 infection. mild cases: participants have mild symptoms such as anosmia, loss of taste, fever or respiratory tract symptoms, gastrointestinal symptoms, etc. and free chest imaging. moderate cases: participants have symptoms such as fever, respiratory tract symptoms, gastrointestinal symptoms, etc. and pneumonia manifestations can be seen in chest imaging

Exclusion criteria
Last imported at : June 24, 2023, midnight
Source : ClinicalTrials.gov

age below 18 years or above 60 years. pregnancy, lactation. any co-morbidities e.g. (dm, hypertension, asthma) participants receiving immunosuppressive or chemotherapy drugs. active malignancy severe confirmed cases, fulfilling any of the following criteria: respiratory rate more than 30/min. blood oxygen saturation of less than 93%. lung infiltrates >50% of the lung fields or rapid progression within 24-48 hours. participants need respiratory support e.g. high flow oxygen, non-invasive or invasive mechanical ventilation. critical cases defined as: occurrence of respiratory failure requiring mechanical ventilation; presence of shock; other organ failure that requires monitoring and treatment in the icu

Number of arms
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

Ain Shams University

Inclusion age min
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

64

Countries
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

Egypt

Type of patients
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

150

primary outcome
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

symptoms improvement

Notes
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 24, 2023, midnight
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : June 21, 2023, 4 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1022, "treatment_name": "Probiotics", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]