Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP)

University of Minnesota (UMN)

Status and phase: Completed; Phase 3

Conditions: Corona Virus Infection; SARS-CoV Infection; Acute Respiratory Distress Syndrome; Coronavirus Infections; Coronavirus

Treatments: Other: Placebo; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04308668

MED-2020-28673

Details and patient eligibility

About

Study Objective:

1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus.
2. To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.

Full description

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging viral infection causing COVID19. The current strategy uses a public health model of identifying infected cases, isolation, and quarantine to stop transmission. Once exposed, observation is standard-of-care. Therapy is generally not given to persons who are not hospitalized. The doses of hydroxychloroquine being used are within the normal standard FDA-approved doses.

Hydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID-19 disease or early preemptive therapy may decrease disease severity. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide post-exposure prophylaxis to prevent disease or preemptive therapy for those with early symptoms. People around the the United States and Canada can participate to help answer this critically important question. No in-person visits are needed.

This trial is targeting 5 groups of people NATIONWIDE to participate:

1. If you are symptomatic with a positive COVID-19 test within the first 4 days of symptoms and are not hospitalized; OR
2. If you live with someone who has been diagnosed with COVID-19, with your last exposure within the last 4 days, and do not have any symptoms; OR
3. If you live with someone who has been diagnosed with COVID-19, and your symptoms started within the last 4 days; OR
4. If you have had occupational exposure with known exposure to someone with lab-confirmed COVID-19 within the last 4 days and do not have symptoms; OR
5. If you have had occupational exposure with known exposure to someone with lab-confirmed COVID-19 within the last 4 days AND have compatible symptoms starting within the last 4 days;

You may participate if you live anywhere in the United States (including territories) or in the Canadian Provinces of Quebec, Manitoba, Alberta, or Ontario.

For information on how to participate in the research trial, go to covidpep.umn.edu or email [e-mail] for instructions. Please check your spam folder if you email.

In Canada, for trial information, please go to: www.covid-19research.ca

Enrollment: 1,312 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of informed consent
• Exposure to a COVID19 case within 4 days as either a household contact or occupational exposure, OR
• Symptomatic COVID19 case with confirmed diagnosis within 4 days of symptom onset OR symptomatic high risk exposure with known COVID19 contact and within 4 days of symptom onset;

Exclusion criteria

• Current hospitalization

• Allergy to hydroxychloroquine

• Retinal eye disease

• Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency

• Known chronic kidney disease, stage 4 or 5 or receiving dialysis

• Structural or ischemic heart disease

• Personal or Family History of Prolonged QT syndrome

• Weight < 50 kg

• Known Porphyria

• Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal, sotalol;

• Current use of medicines which prolong the QT interval including:

  • Antimicrobials: levofloxacin, ciprofloxacin, moxifloxacin, azithromycin, clarithromycin, erythromycin, ketoconazole, itraconazole, or mefloquine
  • Antidepressants: amitriptyline, citalopram, desipramine, escitalopram, imipramine, doxepin, fluoxetine, wellbutrin, or venlafaxine
  • Antipsychotic or mood stabilizers: haloperidol, droperidol, lithium, quetiapine, thioridazine, ziprasidone
  • Methadone
  • Sumatriptan, zolmitriptan

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,312 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Participants in this arm will receive the study drug.

Treatment:

Drug: Hydroxychloroquine

Placebo

Placebo Comparator group

Description:

Participants in this arm will receive a placebo treatment.

Treatment:

Other: Placebo