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,
Colson P, Rolain JM, Lagier JC, Brouqui P, Raoult D. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents. 2020 Apr;55(4):105932. doi: 10.1016/j.ijantimicag.2020.105932. Epub 2020 Mar 4. — View Citation
Day M. Covid-19: identifying and isolating asymptomatic people helped eliminate virus in Italian village. BMJ. 2020 Mar 23;368:m1165. doi: 10.1136/bmj.m1165. — View Citation
Devaux CA, Rolain JM, Colson P, Raoult D. New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19? Int J Antimicrob Agents. 2020 May;55(5):105938. doi: 10.1016/j.ijantimicag.2020.105938. Epub 2020 Mar 12. — View Citation
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:. — View Citation
Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 May 5;172(9):577-582. doi: 10.7326/M20-0504. Epub 2020 Mar 10. — View Citation
Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, Li Y, Hu Z, Zhong W, Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020 Mar 18;6:16. doi: 10.1038/s41421-020-0156-0. eCollection 2020. — View Citation
Marquis-Gravel G, Roe MT, Turakhia MP, Boden W, Temple R, Sharma A, Hirshberg B, Slater P, Craft N, Stockbridge N, McDowell B, Waldstreicher J, Bourla A, Bansilal S, Wong JL, Meunier C, Kassahun H, Coran P, Bataille L, Patrick-Lake B, Hirsch B, Reites J, Mehta R, Muse ED, Chandross KJ, Silverstein JC, Silcox C, Overhage JM, Califf RM, Peterson ED. Technology-Enabled Clinical Trials: Transforming Medical Evidence Generation. Circulation. 2019 Oct 22;140(17):1426-1436. doi: 10.1161/CIRCULATIONAHA.119.040798. Epub 2019 Oct 21. Review. — View Citation
Mitjà O, Clotet B. Use of antiviral drugs to reduce COVID-19 transmission. Lancet Glob Health. 2020 May;8(5):e639-e640. doi: 10.1016/S2214-109X(20)30114-5. Epub 2020 Mar 19. — View Citation
Principi N, Esposito S. Chloroquine or hydroxychloroquine for prophylaxis of COVID-19. Lancet Infect Dis. 2020 Oct;20(10):1118. doi: 10.1016/S1473-3099(20)30296-6. Epub 2020 Apr 17. — View Citation
Rolain JM, Colson P, Raoult D. Recycling of chloroquine and its hydroxyl analogue to face bacterial, fungal and viral infections in the 21st century. Int J Antimicrob Agents. 2007 Oct;30(4):297-308. Epub 2007 Jul 16. Review. — View Citation
Spaccarotella CAM, Polimeni A, Migliarino S, Principe E, Curcio A, Mongiardo A, Sorrentino S, De Rosa S, Indolfi C. Multichannel Electrocardiograms Obtained by a Smartwatch for the Diagnosis of ST-Segment Changes. JAMA Cardiol. 2020 Aug 31. doi: 10.1001/jamacardio.2020.3994. [Epub ahead of print] — View Citation
Turakhia MP, Desai M, Hedlin H, Rajmane A, Talati N, Ferris T, Desai S, Nag D, Patel M, Kowey P, Rumsfeld JS, Russo AM, Hills MT, Granger CB, Mahaffey KW, Perez MV. Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study. Am Heart J. 2019 Jan;207:66-75. doi: 10.1016/j.ahj.2018.09.002. Epub 2018 Sep 8. — View Citation
van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. — View Citation
Vincent MJ, Bergeron E, Benjannet S, Erickson BR, Rollin PE, Ksiazek TG, Seidah NG, Nichol ST. Chloroquine is a potent inhibitor of SARS coronavirus infection and spread. Virol J. 2005 Aug 22;2:69. — View Citation
Wiersinga WJ, Rhodes A, Cheng AC, Peacock SJ, Prescott HC. Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020 Aug 25;324(8):782-793. doi: 10.1001/jama.2020.12839. Review. — View Citation
* 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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