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Trial - NCT04399356


Column Value
Trial registration number NCT04399356
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

Harry P Selker, MD

Contact
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

Dorothy Dulko, ddulko@tuftsmedicalcenter.org (PI email not reported)

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-05-22

Recruitment status
Last imported at : Oct. 29, 2021, 11:30 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

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

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - positive sars-cov-2 test by pcr - no requirement of oxygen supplementation - ability to take oral medication

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- known allergic reactions to any components of niclosamide medication - participation in another trial or use of any experimental treatment for covid-19, including chloroquine, hydroxychloroquine, remdesivir, and lopinavir/ritonavir - hospitalization or requirement of hospitalization at the time of enrollment

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Tufts Medical Center

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

73

primary outcome
Last imported at : April 13, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Time to Respiratory Viral Clearance

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 883, "treatment_name": "Niclosamide", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]