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Trial - NCT04332107


Column Value
Trial registration number NCT04332107
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04332107

First author
Last imported at : March 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Catherine Oldenburg, ScD, MPH;Thuy Doan, MD, PhD

Contact
Last imported at : March 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Jessica M Brogdon, ACTIONTrial@ucsf.edu (PI email not reported)

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

2020-04-02

Recruitment status
Last imported at : Sept. 11, 2021, 4 a.m.
Source : ClinicalTrials.gov

Terminated

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: - evidence of a positive sars-cov-2 test and test results received within the previous seven days - not currently hospitalized - willing and able to receive study drug by mail - willing and able to do the study questionnaires at baseline, day 3, 7, 14, 21 days via email or over the phone - no known allergy or other contraindication to macrolides - age 18 years or older at the time of enrollment - no known history of prolongation of the qt interval (eg. history of torsades de pointes, congenital long qt syndrome, bradyarrhthmia) - no recent use of hydroxychloroquine within the past 7 days for participants >55 years of age - not currently taking nelfinavir or warfarin (coumadin) - provision of informed consent - not currently pregnant

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

None

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

Thomas M. Lietman

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 : Oct. 26, 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/moderate disease at enrollment

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

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Sept. 11, 2021, 4 a.m.
Source : ClinicalTrials.gov

263

primary outcome
Last imported at : Sept. 11, 2021, 4 a.m.
Source : ClinicalTrials.gov

Number of Participants Who Were Symptom Free at Day 14

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 3

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

[{"arm_notes": "", "treatment_id": 165, "treatment_name": "Azithromycin", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]