| Trial registration number
|
NCT04477083 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04477083
|
First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Ibrahim M. El-Sherbiny
|
Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Not reported
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2020-07-20
|
Recruitment status
Last imported at : July 18, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
|
Unknown
|
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
|
Crossover
|
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:
- age ≥ 18 year
- laboratory (rt-pcr) positive of sars-cov-2 (moderate cases)
- chest ct with pneumonia.
- sao2/spo2 ratio > 93% or pao2/fio2 ratio > 300 mmhg under the condition in the
hospital room.
- welling to participate and able to give fully informed consent
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
- severe and critical illness.
- retinopathy and other retinal diseases.
- arrhythmias.
- qt ≥ 400 msec
- receiving cardiac drugs
- severe liver disease.
- pregnancy or lactation.
- previous treatment of covid-19.
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Mansoura University
|
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
|
100
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Egypt
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Moderate disease at enrollment
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
3: Moderate disease at enrollment
|
Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
40
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Time to achieve viral clearance state determined by two successive negative PCR results for two oropharyngeal swabs separated by 48 hours.;Time to clinical recovery defined as 3 days afebrile with improved cough and other clinical signs
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
|
Not reported
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "Inhalable hydrochloroquine", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|