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COVID prevention trial for seniors pulled before it started

NCT ID NCT04397328

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study aimed to see if hydroxychloroquine could prevent COVID-19 in older adults living in long-term care homes. It planned to give either the drug or a placebo to high-risk residents after they were exposed to the virus. However, the trial was withdrawn before enrolling anyone, so no data were collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydroxychloroquine
What this could lead to
If it had worked, this could have pointed toward a way to prevent COVID-19 in vulnerable older adults using a widely available drug.
What could go wrong
The trial was withdrawn before any participants were enrolled, so no results exist. Earlier studies on hydroxychloroquine for COVID-19 showed mixed or negative results and raised safety concerns.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Expected to start

May 2020

An estimate. Start dates often move.

Expected to finish

Apr 2021

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age over 40 with two or more high-risk comorbidities that have been found to confer a higher risk of mortality including but not limited to : chronic lung disease to include: Chronic obstructive lung disease, interstitial lung disease or diffuse parenchymal disease moderate to severe asthma * Cardiac conditions to include: recent myocardial infarction (within the last three months) or poorly controlled heart failure * severe obesity (body mass index \[BMI\] of 40 or higher) * Diabetes (type 1 or 2) * chronic kidney disease undergoing dialysis * liver cirrhosis OR Age over 60. 2. Patient/resident in an Institute (to include a rehabilitation, long term care facility, mental health facility or veteran's care) that provides bed-based care in shared semi-private or ward rooms (i.e. two or more to a room) with a patient with confirmed COVID-19 for at least 6 hours in the absence of contact and droplet precautions. 3. Exposure with a documented or suspected COVID-19 case or from a symptomatic ( defined as common symptoms of COVID-19 including but not limited to fever, lethargy, dry cough, shortness of breath) health care worker providing direct patient contact within 3 feet without a mask for \> 15min or any physical contact with the staff. Exposure may occur in single or shared bedrooms. Exposure may occur in a common dining or activity or sitting area. Any patient sharing a room or within 3 feet for \> 15min or any physical contact without a mask will be considered as a contact. Patients or staff are considered as infectious for 48hrs before any symptoms onset and until masked or cleared by 2 negative swabs. 4. No prior treatment with acetaminophen or NSAIDs or willing to stop present prescription of regular or PRN acetaminophen. 5. Informed consent (in person or by telephone/e-mail with SDM) Exclusion Criteria: 1. Greater than 96 hours since last exposure 2. Presence of fever (T\>37.8), new onset cough, or shortness of breath at enrollment 3. A baseline O2 saturation less than 90% (as measured by pulse oximetry) on room air 4. Screening ECG QTc interval greater than 500ms by either a 12 lead or 6 lead ECG. 5. Concomitant drug-drug interactions (Artemether, Dapsone, Lumefantrine or Mefloquine amiodarone, digoxin, dofetilide, flecainide, procainamide, sotalol, or propafenone levofloxacin, ciprofloxacin, moxifloxacin, azithromycin, clarithromycin, erythromycin, ketoconazole, or itraconazole methadone sumatriptan, or zolmitriptan systemic chemotherapy.) 6. Already on active palliative care measures (Palliative performance score (PPS) less than 30%) 7. Hypersensitivity reaction to chloroquine, hydroxychloroquine or aminoquinolines 8. History of retinal disease due to previous use of 4-aminoquinoline 9. Prior documented and known at enrollment, retinal eye disease or maculopathy including but not limited to diabetic retinopathy, retinal detachment, retinitis pigmentosa or macular degeneration 10. Known glucose-6 phosphate dehydrogenase (G6PD) deficiency 11. Known Porphyria 12. Acute delirium 13. Inability to swallow oral study drug/placebo (even after crushed in the same manner as regular prescribed medications) 14. Diagnosis of immunodeficiency (e.g. HIV, transplantation) or receiving systemic steroid therapy (\>10mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment 15. Women who are pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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