Last updated: December 8, 2020
Sponsor: St. Francis Hospital, New York
Overall Status: Completed
Phase
4
Condition
Covid-19
Treatment
N/AClinical Study ID
NCT04370782
20-21
Ages > 30 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Able to read and understand informed consent.
- High initial clinical suspicion by physician based on signs and symptoms (fever,cough, myalgias, fatigue, shortness of breath) followed by RT-PCR for confirmation ofCOVID-19 diagnosis
- Any gender
- Age 60 years and older
- Age 30-59 years with one or more of the following:
- abnormal lung exam
- abnormal oxygen staturation <95%
- abnormal chest x-ray or chest CT
- persistent fever >100.4 degrees Fahrenheit upon arrival to Emergency department (ED)
- one of the following co-morbidities: hypertension, diabetes mellitus, history ofcoronary artery disease, chronic kidney disease (CKD), asthma, chronicobstructive pulmonary disease, current or former smoker, or morbid obesity (BodyMass Index ≥35)
Exclusion
Exclusion Criteria:
- Pregnant or breastfeeding female
- Severe COVID-19 requiring admission for inpatient treatment
- Need for any oxygen supplementation
- Need for mechanical ventilatory support
- History of oxygen supplementation dependency
- History of cancer with ongoing chemotherapy or radiation therapy
- Concurrent antimicrobial therapy
- Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds
- Already taking hydroxychloroquine or chloroquine within 1 month
- Known G6-PD deficiency
- History of retinopathy
- History of current cardiac diseases (heart failure, ventricular arrhythmias, Leftbundle branch block and/or Right bundle branch block, QTc prolongation >480ms), orfamily history of sudden cardiac death
- Ongoing use of drugs that prolong the QTc interval (antipsychotics, antidepressants,class I and III antiarrhythmics, triptans)
- Severe renal disease: glomerular filtration rate (GFR) <30ml/min
- Severe hepatic impairment (elevated total bilirubin >2 mg/dL, decreased albumin <2.8g/dL, signs of jaundice and ascites.)
- Active alcohol abuse (>5 drinks per day or >20 drinks per week.)
- Seizure disorder, currently on medications
- Known hypersensitivity to any tetracyclines.
Study Design
Total Participants: 18
Study Start date:
April 28, 2020
Estimated Completion Date:
September 30, 2020
Study Description
Connect with a study center
St Francis Hospital
Roslyn, New York 11576
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.