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Trial - NCT04336332


Column Value
Trial registration number NCT04336332
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04336332

First author
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Sabiha Hussain

Contact
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

hussaisa@rwjms.rutgers.edu

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

2020-04-07

Recruitment status
Last imported at : March 1, 2023, 9:56 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

Open label

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

multi-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: - patients with proven sars-cov-2 infection by an accepted assay with symptoms consistent with covid-19 - ability to measure and quantify viral load by quantitative pcr - age 18 to 89 - ability to swallow oral medications - patients must read, understand and sign irb approved informed consent

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

- pregnancy or women who are breast feeding - two consecutive negative assays for sars-cov-2 infection - patients that lack decision-making capacity will not be approached to participate in this study - inability to tolerate oral medications - allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate - qtc interval > 470 msec - history of ongoing ventricular cardiac dysrhythmias of grade 2 as described by nci ctcae 5.0 criteria - history of serious ventricular arrhythmia (vt or vf > 3 beats in a row)

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

3

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

Rutgers, The State University of New Jersey

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

89

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

No restriction on type of patients

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

0: No restriction on type of patients

Total sample size
Last imported at : March 1, 2023, 9:56 a.m.
Source : ClinicalTrials.gov

75

primary outcome
Last imported at : March 1, 2023, 9:56 a.m.
Source : ClinicalTrials.gov

Changes in Patients Viral Load

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": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]