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| Column | Value |
|---|---|
| Trial registration number | NCT04979884 |
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Full text link
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
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First author
Last imported at : July 28, 2023, 8 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 28, 2023, 8 a.m. Source : ClinicalTrials.gov |
None |
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Registration date
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
2021-07-28 |
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Recruitment status
Last imported at : July 28, 2023, 8 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : July 28, 2023, 8 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : July 28, 2023, 8 a.m. Source : ClinicalTrials.gov |
inclusion criteria: current infection with covid-19 written informed consent confirmed diagnosis of covid-19 by pcr (polymerase chain reaction) tests and/or positive serology or any existing and validated diagnostic covid-19 parameters during this time. 18yrs ≥ age <66 yrs chest x-ray showing suggestive of covid-19 disease. both gender the presence of pulmonary fibrosis or hyper inflammation signs or a syndrome of cytokine release defined as any of the following:: leukopenia or lymphopenia, ferritin > 500ng/ml or d-dimers ≥ 500 ng/ml hs>90 |
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
lactation and pregnancy women unlikely to survive beyond 48h need for mechanical ventilation. cases of multiorgan failure or abnormal renal function and shock. malignancies, autoimmune disease, perforation of the bowels or diverticulitis. active bacterial or fungal infection. we define impairment of cardiac function as poorly controlled heart diseases, cardiac insufficiency, unstable angina pectoris, myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia needs treatment or intervention, uncontrolled hypertension (>180/110 mmhg. levels of serum transaminase >5 upper references rang symptoms of active tuberculosis or human immunodeficiency virus (hiv) positivity the patient receiving vaccines: live, attenuated vaccines subjects received monoclonal antibodies within one week before admission. patients receiving high-dose systemic steroids (> 20 mg methylprednisolone or equivalent), immunosuppressant or immunomodulatory drugs contraindications for use in people with psoriasis include concomitant treatment with methotrexate, other immunosuppressant agents, coal tar, or radiation therapy. - |
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Number of arms
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
Alexandria University |
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Inclusion age min
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
65 |
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Countries
Last imported at : July 28, 2023, 8 a.m. Source : ClinicalTrials.gov |
Egypt |
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Type of patients
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : July 28, 2023, 8 a.m. Source : ClinicalTrials.gov |
102 |
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primary outcome
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
Percentage of subjects with a 6-point ordinal scale showing each severity level |
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Notes
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : July 29, 2021, noon Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 283, "treatment_name": "Ciclosporin", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |