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| Column | Value |
|---|---|
| Trial registration number | NCT04573322 |
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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 : Nov. 1, 2021, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : Nov. 1, 2021, noon Source : ClinicalTrials.gov |
Harry N Cook, hcook@diffusionpharma.com (PI email not reported) |
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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 : Nov. 1, 2021, noon Source : ClinicalTrials.gov |
Completed |
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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 |
Adaptive |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Oct. 26, 2020, 11:31 p.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 : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: hospitalized subjects with confirmed sars-cov-2 infection and hypoxemia, defined as spo2 < 94% on room air or requiring supplemental oxygen laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen < 72 hours prior to enrollment. who ordinal scale score of 3, 4 or 5 at baseline male or non-pregnant female adult ≥18 years of age at time of enrolment. subject (or legally authorized representative (lar)) provides written informed consent prior to initiation of any study procedures. understands and agrees to comply with planned study procedures. illness of any duration women of childbearing potential must have a negative blood pregnancy test at the screening/baseline visit (day 1) and agree to use a double method of birth control through 30 days after the last dose of study drug. |
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
intubated and mechanically ventilated at baseline receiving extracorporeal membrane oxygenation (ecmo) at baseline severe organ dysfunction (sofa score > 10) patient or lar unable to provide written informed consent alt/ast > 3 times the upper limit of normal or serum bilirubin > 1.5 times the upper limit of normal estimated glomerular filtration rate (egfr) by modification of diet in renal disease (mdrd) formula < 30 ml/min/1.73 m^2 or on dialysis pregnancy or breast feeding. anticipated transfer to another hospital which is not a study site within 72 hours. allergy to any study medication |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
6 |
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Funding
Last imported at : Dec. 4, 2022, 8 p.m. Source : ClinicalTrials.gov |
Diffusion Pharmaceuticals Inc |
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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 |
Romania |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : Nov. 1, 2021, noon Source : ClinicalTrials.gov |
25 |
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primary outcome
Last imported at : Dec. 4, 2022, 8 p.m. Source : ClinicalTrials.gov |
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability);Time to Recovery Through Day 28 |
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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 1/Phase 2 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "0.25 mg/kg", "treatment_id": 1215, "treatment_name": "Sodium crocetinate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "0.50 mg/kg", "treatment_id": 1215, "treatment_name": "Sodium crocetinate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "1.0 mg/kg", "treatment_id": 1215, "treatment_name": "Sodium crocetinate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "1.5 mg/kg", "treatment_id": 1215, "treatment_name": "Sodium crocetinate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "optimum safe and tolerable dose", "treatment_id": 1215, "treatment_name": "Sodium crocetinate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |