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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04746365 |
|
Full text link
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-02-09 |
|
Recruitment status
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Adaptive |
|
Masking
Last imported at : Feb. 11, 2021, 12:31 a.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 : Feb. 11, 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: subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. understands and agrees to comply with planned study procedures. agrees to the collection of op swabs and venous blood per protocol. male or non-pregnant female adult ≥18 years of age at time of enrollment. has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other severe cases according to who definition. |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
alt/ast > 5 times the upper limit of normal. mortality within 12 hours of admission. pregnancy. anticipated transfer to another hospital within 24 hours. allergy to any study medication commercial or public health assay in any specimen prior to randomization. mechanically ventilated on admission |
|
Number of arms
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Elaraby Hospital |
|
Inclusion age min
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Egypt |
|
Type of patients
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
|
Severity scale
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
|
Total sample size
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
300 |
|
primary outcome
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Reduction in the WHO ordinal scale of clinical status by at least two points;Time to discharge |
|
Notes
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |