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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04652648
Other study ID # BM02332
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 27, 2020
Est. completion date November 15, 2020

Study information

Verified date December 2020
Source Bryn Mawr Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

- 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


Description:

Household members were contacted by telephone and provided consent forms via E-mail electronic signatures. Randomization was 2:1 to HCQ 200 mg BID or observation for 10 days with total follow-up of 14 days. COVID status was determined by home saliva PCR assay on days 1 and 14. Study drug was shipped to participants. Data of daily symptoms and 6-lead ECGs using a smartphone KardiaMobile® 6L application were collected.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hydroxychloroquine
Randomization was 2:1 to HCQ 200 mg BID or 41 observation for 10 days

Locations

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

Sponsors (4)

Lead Sponsor Collaborator
Bryn Mawr Hospital Bryn Mawr Hospital Foundation, Cotswold Foundation, Sharpe-Strumia Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (15)

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 allClick here to view all references

Outcome

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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