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Trial - NCT04349592


Column Value
Trial registration number NCT04349592
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04349592

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

Not reported

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

Not reported

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

2020-04-16

Recruitment status
Last imported at : Feb. 25, 2021, 7:58 p.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 : Oct. 26, 2020, 11:31 p.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: - patient is in hmc facility for low-acuity, covid-positive patients being quarantined. - positive covid test on qualitative assay used during routine care (i.e. not as part of q-protect) - age at least 18

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

- treating physician judges patient not appropriate for study participation for any reason - age <18 - breastfeeding or pregnancy (patient-reported pregnancy status is sufficient) - hypersensitivity to chloroquine or hc or az - history of or known qt prolongation - ekg required before study entry and on each visit during the subject's first seven days on pro-tocol, during the time period hc is being taken - baseline qtc >480 if qrs width normal; qtc >510 if qrs >120 - known g6pd deficiency, porphyria, or retinopathy (eye exam prior to study entry) - known hepatic or renal disease (or abnormality on liver or renal function testing at study day 1) - low magnesium or low potassium (by testing on day 1) - current (pre-study) therapy with antimalarial or dapsone - current (pre-study) therapy with antiviral agents (e.g. oseltamivir) - tisdale36 score exceeding 6 as tallied below (based on acc recommendations)* - 1 point each: age>67, female sex, or being on loop diuretic - 2 points each: serum potassium <3.6, qtc>449, acute myocardial infarction - 3 points each: sepsis, heart failure, qt-prolonging drugs

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

Hamad Medical Corporation

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

100

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

Qatar

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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

456

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

Proportion of virologically cured (PCR-negative status) as assessed on day six

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

None

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

Not reported

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": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]