Pre-exposure Prophylaxis for SARS-Coronavirus-2

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04328467
• Other study ID #: MED-2020-28720
• Status: Completed
• Phase: Phase 3
• Start date: April 6, 2020
• Est. completion date: July 13, 2020

Study information

• Verified date: June 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1483
• Est. completion date: July 13, 2020
• Est. primary completion date: July 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A healthcare worker at high risk for COVID-19 exposure (defined below):
• Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel)
• Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists)
• Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists (CRNAs)
• First responders (i.e. EMTs, paramedics)

Exclusion Criteria:

• Active COVID-19 disease
• Prior COVID-19 disease
• Current fever, cough, shortness of breath
• Allergy to chloroquine or hydroxychloroquine
• Prior retinal eye disease
• Known Chronic Kidney disease, Stage 4 or 5 or dialysis
• Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
• Weight <40 kg
• Prolonged QT syndrome
• Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide, amiodarone, digoxin, procainamide, or propafenone
• Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen, or methotrexate.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• ARDS
• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine; 200mg tablet; oral

Other:
• Placebo
Placebo; tablet; oral

Locations

Country	Name	City	State
United States	Nationwide Enrollment via Internet, please email: covid19@umn.edu	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rajasingham R, Bangdiwala AS, Nicol MR, Skipper CP, Pastick KA, Axelrod ML, Pullen MF, Nascene AA, Williams DA, Engen NW, Okafor EC, Rini BI, Mayer IA, McDonald EG, Lee TC, Li P, MacKenzie LJ, Balko JM, Dunlop SJ, Hullsiek KH, Boulware DR, Lofgren SM; COV — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19-free Survival	Outcome reported as the number of participants in each arm who are COVID-19-free at the end of study treatment.	up to 12 weeks
Secondary	Number of Confirmed SARS-CoV-2 Detection	Outcome reported as the number of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.	up to 12 weeks
Secondary	Incidence of Possible COVID-19 Symptoms	Outcome reported as the count of participants in each arm who report COVID-19-related symptoms during study treatment.	up to 12 weeks
Secondary	Incidence of All-cause Study Medicine Discontinuation	Outcome reported as the count of participants in each arm who discontinue study medication use for any reason during treatment.	up to 12 weeks
Secondary	Ordinal Scale of COVID-19 Disease Maximum Severity if COVID-19 Diagnosed at Study End	Participants will self-report COVID-19 status on an ordinal scale as follows: No illness (score=1), Illness with outpatient observation (score=2), Hospitalization (or post-hospital discharge) (score=3), or Hospitalization with ICU stay or death (score=4). Possible scores range from 1-4 with higher scores indicating greater disease severity.	up to 12 weeks
Secondary	Incidence of Hospitalization for COVID-19 or Death	Outcome reported as the number of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.	up to 12 weeks
Secondary	Incidence of Possible Study Medication-related Side Effects	Outcome reported as the number of participants in each arm who experience possible medication-related side effects during study treatment.	up to 12 weeks