NCT04308668

Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2

Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,312 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Corona Virus Infection
• Acute Respiratory Distress Syndrome
• SARS-CoV Infection
• Coronavirus
• Coronavirus Infections

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days
OTHER	Placebo	4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days

Timeline

• Start date: 2020-03-17
• Primary completion: 2020-05-20
• Completion: 2020-05-20
• First posted: 2020-03-16
• Last updated: 2021-05-13
• Results posted: 2021-05-13

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study