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Covid19Phase 4NCT04652648

Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts

A Phase 4 study testing Hydroxychloroquine in people with Covid19 and Hydroxychloroquine, run by Bryn Mawr Hospital at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Covid19, Hydroxychloroquine, Coronavirus Infection
What is being tested?
Hydroxychloroquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
3 sitesUnited States
Study dates
27 May 2020to 15 Nov 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • allergy or intolerance to hydroxychloroquine (PlaquenilR);
  • weight less than 85 pounds;
  • eye disease affecting the retina;
  • severe kidney or liver disease;
  • G6PD-deficiency;
  • porphyria;
Show all 13Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Paoli Hospital

    Paoli, Pennsylvania, 19301

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

  • 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
Read the detailed 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.

Being tested
Hydroxychloroquine
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydroxychloroquineDrug

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

Study groups in NCT04652648
Study groupRoleWhat they receive
HydroxychloroquineActive comparatorRandomization was 2:1 to HCQ 200 mg BID for 10 days
Receives: Drug: Hydroxychloroquine
ControlNo interventionNo Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: within 14 days

Secondary outcomes (7)

  1. Positive coronavirus PCR test without symptoms

    Development of a positive coronavirus PCR test without symptoms by Day 14

    Measured: By Day 14 (end of study)

  2. Hospital admission for COVID-19

    hospital admission for COVID-19 symptoms by Day 14

    Measured: within 14 days of study entry

  3. Death by Day 14

    Death due to COVID-19 within 14 days of study entry

    Measured: within 14 days of study entry

  4. HCQ discontinuation or study withdrawal

    All-cause discontinuation of study medication or study withdrawal by Day 14

    Measured: within 14 days of study entry

  5. Symptom severity at specified time points

    overall symptom severity at Day 7 and Day 14

    Measured: at Day 7 and at Day 14 from study entry

  6. COVID -19 rate at study entry

    household attack rate at study entry

    Measured: Day 1 of study

  7. EKG changes during study

    documentation of EKG changes such as QTc prolongation on HCQ compared with no drug therapy

    Measured: Day 1 thru Day 14 of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2020
  2. Study start27 May 2020
  3. Primary completion31 Oct 2020
  4. Study completion15 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04652648
Sponsor's protocol ID
BM02332
Status last verified
Dec 2020
First submitted
2 Dec 2020
Last updated
3 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31986264

  • 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.

    PubMed 32648899

  • 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. No abstract available.

    PubMed 32182409

  • 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.

    PubMed 32150748

  • 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. No abstract available.

    PubMed 32205334

  • 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. doi: 10.1016/j.ijantimicag.2007.05.015. Epub 2007 Jul 16.

    PubMed 17629679

  • 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.

    PubMed 32171740

  • 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. No abstract available.

    PubMed 32145363

  • 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. No abstract available.

    PubMed 32194981

  • Mitja 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. No abstract available.

    PubMed 32199468

  • 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. doi: 10.1186/1743-422X-2-69.

    PubMed 16115318

  • 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. No abstract available.

    PubMed 32311322

  • 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.

    PubMed 31634011

  • 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.

    PubMed 30392584

  • 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 Oct 1;5(10):1176-1180. doi: 10.1001/jamacardio.2020.3994.

    PubMed 32865545

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hydroxychloroquine in people with Covid19 and Hydroxychloroquine, run by Bryn Mawr Hospital at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COVID-19 symptom development with positive PCR test (time frame: within 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04652648, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.

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