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Trial - NCT05043350


Column Value
Trial registration number NCT05043350
Full text link
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05043350

First author
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

Samar Saad elDeen Azab

Contact
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

2021-09-14

Recruitment status
Last imported at : Aug. 27, 2023, 8 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Aug. 27, 2023, 8 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: adult patients (>18 years old). confirmed covid-19 infection with pcr. moderate covid patients who with sp02 <92 % ct chest infiltration more than 50 % presented to the hospital within 24 to 48 hours cbc (wbcs may be normal or high or low with lymphocytopenia is present, decreased hemoglobin, neutrophilia with neutrophil/lymphocyte ratio > 3.1)

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

hepatic or renal failure: (alanine transaminase or aspartate transaminase >3 times above the normal limit) history or evidence of long qt segment on electrocardiogram, pregnancy or breast-feeding mother patient on mechanical ventilator. patient who received vaccine. patients receiving antidepressants, opioids, (e.g., anticonvulsants, clonazepam).

Number of arms
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

Ain Shams University

Inclusion age min
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

2

Inclusion age max
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Aug. 27, 2023, 8 a.m.
Source : ClinicalTrials.gov

Egypt

Type of patients
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

214

primary outcome
Last imported at : Aug. 27, 2023, 8 a.m.
Source : ClinicalTrials.gov

Assessment of number of patients who will need Mechanical ventillation;Assessment of the number of patients who will need vasopressor due to progression to shock

Notes
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : Sept. 16, 2021, 5 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 503, "treatment_name": "Famotidine", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1910, "treatment_name": "Famotidine+loratidine", "treatment_type": "Others pharmacological treatment+respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}]