NCT04328467

Pre-exposure Prophylaxis for SARS-Coronavirus-2

Pre-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,483 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.

Detailed description

The current standard of care is observation and quarantine after exposure to COVID-19. There is no approved treatment or prophylaxis for COVID-19. As of March 6, 2020, the CDC estimates that the transmission of SARS-CoV2 after a U.S. household close contract is 10.5% (95%CI, 2.9 to 31.4%). Among all close contacts, the SARS-CoV2 transmission rate is estimated at 0.45% (95%CI, 0.12 to 1.6%) by the CDC. These estimates are based on monitoring of travel-associated COVID19 cases. Conversely, in a setting with community transmission, the secondary attack rate in China was 35% (95%CI, 27-44%) based on 48 transmissions among 137 persons in 9 index patients. Chloroquine or Hydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID-19 disease or reduce disease severity. It is not known at what dosing hydroxychloroquine may be effective for pre-exposure prophylaxis.

Conditions

• COVID-19
• Corona Virus Infection
• ARDS
• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Hydroxychloroquine; 200mg tablet; oral
OTHER	Placebo	Placebo; tablet; oral

Timeline

• Start date: 2020-04-06
• Primary completion: 2020-07-13
• Completion: 2020-07-13
• First posted: 2020-03-31
• Last updated: 2021-07-02
• Results posted: 2021-06-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study