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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04573153 |
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Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
ldoganay@hotmail.com |
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Registration date
Last imported at : Nov. 2, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-10-05 |
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Recruitment status
Last imported at : Sept. 30, 2022, 6:30 a.m. Source : ClinicalTrials.gov |
Unknown |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - patients of both genders (females and males) over 18 years of age - written informed consent obtained from the subjects prior to any procedures related to the study - understand all procedures to be applied within the scope of the study protocol - ambulatory patients with symptoms diagnosed with covid-19 with chest tomography (ct) result positivity in the last 72 hours - patients with stable clinical course and who could be treated on an ambulatory basis. |
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- patients who has partial oxygen saturation below 93% and require immediate hospitalisation after diagnosis - patients, upon initial examination, decided to be hospitalised at the intensive care-unit - inability or unwillingness to give written informed consent - at physicians decision, the trial involvement will not be in patients' best interest, or any condition that does not allow the protocol to be followed safely - patients considered as inappropriate for this study for any reason - active participation in another clinical study - uncontrolled type 1 or type 2 diabetes - severe liver disease (e.g. child pugh score ≥ c, ast>5 times upper limit) - patients with known severe renal impairment (estimated glomerular filtration rate ≤30 ml/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis - significant cardiovascular co-morbidity (i.e. heart failure) - patients with phenylketonuria (contraindicated for nac) - known allergy for substances used in the study - pregnant or breastfeeding patients, or patients with positive pregnancy test in a pre-dose examination - receipt of any experimental treatment for covid-19 within the 30 days prior to the time of the screening evaluation. |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
ScandiBio Therapeutics AB |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Turkey |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
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Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
400 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
The evaluation of clinical efficacy of the combination of metabolic cofactor supplementation and hydroxychloroquine |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 2203, "treatment_name": "L-carnitine+n-acetylcysteine+nicotinamide+serine", "treatment_type": "Vitamins and dietary supplements+respiratory agents+nutrition", "pharmacological_treatment": "Pharmacological treatment+non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |