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Trial - NCT04779047


Column Value
Trial registration number NCT04779047
Full text link
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04779047

First author
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Ahmed E Abou warda, BSc

Contact
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

ahmed.essam@o6u.edu.eg

Registration date
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-03-03

Recruitment status
Last imported at : March 14, 2023, midnight
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 5, 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 : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

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

inclusion criteria: hospitalized adult patients with pneumonia evidenced by chest ct scan. laboratory (rt-pcr) confirmed infection with 2019-ncov or strongly suspected to be infected with sars-cov2 with confirmation studies pending. and at least one of the following: respiratory frequency ≥30/min. blood oxygen saturation ≤93% on room air (ra). partial pressure of arterial oxygen to fraction of inspired oxygen ratio (pao2/fio2) <300. worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased fio2 to maintain stable o2 saturation, or worsening o2 saturation of >3% with stable fio2.

Exclusion criteria
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- baseline elevation of alanine aminotransferase (alt) or aspartate aminotransferase (ast) levels > 3-fold the upper limit of the normal range. - pregnancy.

Number of arms
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

October 6 University

Inclusion age min
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

88

Countries
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Egypt

Type of patients
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

150

primary outcome
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Percentage of clinical cure in each arm

Notes
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : March 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1841, "treatment_name": "Lopinavir+remdesivir+ritonavir+tocilizumab", "treatment_type": "Antivirals+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1842, "treatment_name": "Hydroxychloroquine+ivermectin+tocilizumab", "treatment_type": "Antimalarials+antiparasitics+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]