Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts
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ClinicalTrials.gov Identifier: NCT04652648 |
Recruitment Status :
Completed
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
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- 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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 Hydroxychloroquine Coronavirus Infection Transmission Prophylaxis | Drug: Hydroxychloroquine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | May 27, 2020 |
Actual Primary Completion Date : | October 31, 2020 |
Actual Study Completion Date : | November 15, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Hydroxychloroquine
Randomization was 2:1 to HCQ 200 mg BID for 10 days
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Drug: Hydroxychloroquine
Randomization was 2:1 to HCQ 200 mg BID or 41 observation for 10 days |
No Intervention: Control
No Intervention
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- COVID-19 symptom development with positive PCR test [ Time Frame: within 14 days ]The primary endpoint was development of COVID-19 symptoms with a positive coronavirus PCR test by Day 14.
- Positive coronavirus PCR test without symptoms [ Time Frame: By Day 14 (end of study) ]Development of a positive coronavirus PCR test without symptoms by Day 14
- Hospital admission for COVID-19 [ Time Frame: within 14 days of study entry ]hospital admission for COVID-19 symptoms by Day 14
- Death by Day 14 [ Time Frame: within 14 days of study entry ]Death due to COVID-19 within 14 days of study entry
- HCQ discontinuation or study withdrawal [ Time Frame: within 14 days of study entry ]All-cause discontinuation of study medication or study withdrawal by Day 14
- Symptom severity at specified time points [ Time Frame: at Day 7 and at Day 14 from study entry ]overall symptom severity at Day 7 and Day 14
- COVID -19 rate at study entry [ Time Frame: Day 1 of study ]household attack rate at study entry
- EKG changes during study [ Time Frame: Day 1 thru Day 14 of study ]documentation of EKG changes such as QTc prolongation on HCQ compared with no drug therapy

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652648
United States, Pennsylvania | |
Bryn Mawr Hospital | |
Bryn Mawr, Pennsylvania, United States, 19010 | |
Paoli Hospital | |
Paoli, Pennsylvania, United States, 19301 | |
Lankenau Medical Center | |
Wynnewood, Pennsylvania, United States, 19096 |
Responsible Party: | Luciano kapelusznik, Attending Physician, Bryn Mawr Hospital |
ClinicalTrials.gov Identifier: | NCT04652648 |
Other Study ID Numbers: |
BM02332 |
First Posted: | December 3, 2020 Key Record Dates |
Last Update Posted: | December 3, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Coronavirus Infections Severe Acute Respiratory Syndrome Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Hydroxychloroquine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |