Covid19 Clinical Trial
Official title:
Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts
Verified date | December 2020 |
Source | Bryn Mawr Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- organizing an entirely no in-person contact clinical trial is feasible during a 22 COVID-19 pandemic 23 - Remote smartphone 6-lead ECG monitoring is possible even in a group unfamiliar 24 with the technology 25 - Hydroxychloroquine used prophylactically at 200 mg BID had no observable 26 cardiotoxicity 27 - Additional study using this technique is warranted to look at reliability and cost-28 effectiveness
Status | Completed |
Enrollment | 54 |
Est. completion date | November 15, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - exposure to a COVID-19-infected individual in the same household within five days of diagnosis; - age >18 years; - ability to give informed consent to participate in a clinical study; - ability to swallow oral medications; - access to a smartphone Exclusion Criteria: - allergy or intolerance to hydroxychloroquine (PlaquenilR); - weight less than 85 pounds; - eye disease affecting the retina; - severe kidney or liver disease; - G6PD-deficiency; - porphyria; - long QTc EKG abnormality or family history of this; - other major EKG abnormalities; - taking medications that can affect the QT interval including flecainide, amiodarone, digoxin, procainamide, propafenone, sotalol, quinidine, dofetilide, levofloxacin, ciprofloxacin, azithromycin, erythromycin, amitriptyline, doxepin, desipramine, imipramine, fluoxetine, sertraline, venlafaxine, quetiapine, haloperidol, droperidol, thioridazine, ziprasidone, furosemide, sumatriptan or zolmitriptan, cisapride, arsenic, dolasetron, or methadone; - current pregnancy; - current hospitalization; - symptomatic with fever or cough; - lack of access to a smartphone |
Country | Name | City | State |
---|---|---|---|
United States | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania |
United States | Paoli Hospital | Paoli | Pennsylvania |
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Bryn Mawr Hospital | Bryn Mawr Hospital Foundation, Cotswold Foundation, Sharpe-Strumia Research Foundation |
United States,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | COVID-19 symptom development with positive PCR test | The primary endpoint was development of COVID-19 symptoms with a positive coronavirus PCR test by Day 14. | within 14 days | |
Secondary | Positive coronavirus PCR test without symptoms | Development of a positive coronavirus PCR test without symptoms by Day 14 | By Day 14 (end of study) | |
Secondary | Hospital admission for COVID-19 | hospital admission for COVID-19 symptoms by Day 14 | within 14 days of study entry | |
Secondary | Death by Day 14 | Death due to COVID-19 within 14 days of study entry | within 14 days of study entry | |
Secondary | HCQ discontinuation or study withdrawal | All-cause discontinuation of study medication or study withdrawal by Day 14 | within 14 days of study entry | |
Secondary | Symptom severity at specified time points | overall symptom severity at Day 7 and Day 14 | at Day 7 and at Day 14 from study entry | |
Secondary | COVID -19 rate at study entry | household attack rate at study entry | Day 1 of study | |
Secondary | EKG changes during study | documentation of EKG changes such as QTc prolongation on HCQ compared with no drug therapy | Day 1 thru Day 14 of study |
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