COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04363203

Salomeh Keyhani, MD MPH

Not reported

2020-04-27

Suspended

RCT

Randomized

Single group assignment

Blind label

single-center

Treatment

inclusion criteria: - willingness to take the study drug and ability to take oral medications - able to be contacted by phone - willing and able to give informed consent for participation in the study and agrees with its conduct and willing to email the study team a picture of their consent form

exclusion criteria based on national va data: we will exclude individuals based on the following national va data and chart review criteria: - egfr <30ml/min or dialysis - aspartate transaminase (ast) or alanine transaminase (alt) >5 times the upper limit of normal or cirrhosis in past 2 years - hypersensitivity to chloroquine, hydroxychloroquine or other 4-aminoquinolines (e.g., amodiaquine), azithromycin or macrolides - already taking hydroxychloroquine or azithromycin - congestive heart failure with an ejection fraction (ef) <35% in past 2 years or hospitalization within past 6 months - concomitant treatment with any qt prolonging drug - history of cardiac arrest, ventricular fibrillation or ventricular tachycardia in past 5 years - qt prolongation on any ecg in past 5 years - potassium <3.5 meq/l in labs in past 2 years - magnesium< 1/5 meq/l in any lab in past 2 years - any patient who has not had follow-up with their primary care doctors in past 2 years - any veteran who cannot follow-up such as those with dementia, home based primary care or those with active psychosis documented in past 2 years - g6pd deficiency exclusions based on baseline interview: - any female who is breastfeeding or pregnant or planning to become pregnant. - any veteran who receives most of their care in non-va settings - veteran enrolled in another covid trial - veteran received a prescription for azithromycin and hydroxychloroquine - veteran allergic to azithromycin and or hydroxychloroquine - veteran receiving qt prolonging drugs from non-va pharmacy

3

Salomeh Keyhani MD

18

None

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

300

Days to resolution of cough, fever and shortness of breath

None

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"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"}]