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Trial - NCT04900337


Column Value
Trial registration number NCT04900337
Full text link
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04900337

First author
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Yehudit Natan

Contact
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

dity@amorphical.com

Registration date
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2021-05-25

Recruitment status
Last imported at : April 6, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: males and females of age ≥ 18 years and ≤ 80 years signed an informed consent agree to undergo blood tests as per protocol diagnosed with covid-19 evidence of lung involvement (by chest x rays or lung us) may or may not need for supplemental oxygen at enrollment hospitalized

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

pregnant or breast-feeding females patients with non-covid19 related pneumonia any pulmonary disease not related to covid19 tracheostomy high flow oxygen or non-invasive ventilation (bipap) or mechanical ventilation hypercalcemia defined as calcium or corrected calcium > 10.5mg/dl hyperphosphatemia defined as > 4.5mg/dl urine calcium to creatinine ratio >0.14 participating in another clinical study

Number of arms
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Amorphical Ltd.

Inclusion age min
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Israel

Type of patients
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

100

primary outcome
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Change of Severity rating of Disease using an 8-point ordinal scale on days 7, 14, 21, measured as improvement greater than or equal to 1 point from baseline score.

Notes
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Phase 1/Phase 2

Arms
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 77, "treatment_name": "Amorphous calcium carbonate (acc)", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]