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Trial - NCT04937569


Column Value
Trial registration number NCT04937569
Full text link
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04937569

First author
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

Aliae AR Mohamed-Hussein, MD

Contact
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

aliaehussein@aun.edu.eg

Registration date
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

2021-06-24

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

Unknown

Study design
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

Sequential assignment

Masking
Last imported at : June 26, 2021, 2 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 : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - confirmed mild cases of covid-19 defined as: symptomatic patients with any of covid-19 symptoms (fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell), - in addition to absolute leucopoenia (< 4000) / absolute lymphopenia (< 1000), positive crp (c-reactive protein), high serum ferritin and/or positive pcr for sars-cov-2 in nasopharyngeal swab. - no dyspnea and no abnormalities on high resolution chest imaging (hrct). - patients should be at home (not admitted to hospital) with no supplemental oxygen treatment.

Exclusion criteria
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

- • asymptomatic patients - dyspnoea or abnormalities on chest imaging - hospital admission - severe pneumonia - impairment in liver functions - received ivermection in the last 5 days before being included in the study. - pregnancy is an exclusion criterion

Number of arms
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

Assiut University

Inclusion age min
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

Egypt

Type of patients
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

1644

primary outcome
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

Rate of ICU admission in mild COVID-19 cases

Notes
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]