Pre-exposure Prophylaxis for SARS-Coronavirus-2

NCT04328467 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: MED-2020-28720
• Study Type: interventional
• Target: 1,483
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of Confirmed SARS-CoV-2 Detection

  up to 12 weeks

• Incidence of Possible COVID-19 Symptoms

  up to 12 weeks

• Incidence of All-cause Study Medicine Discontinuation

  up to 12 weeks

• Ordinal Scale of COVID-19 Disease Maximum Severity if COVID-19 Diagnosed at Study End

  up to 12 weeks

• Incidence of Hospitalization for COVID-19 or Death

  up to 12 weeks

Study Arms (3)

Intervention Once Weekly

EXPERIMENTAL

400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks

Drug: Hydroxychloroquine

Intervention Twice Weekly

EXPERIMENTAL

400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks

Drug: Hydroxychloroquine

Control Group

PLACEBO COMPARATOR

Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks

Other: Placebo

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine; 200mg tablet; oral

Also known as: Plaquenil

Intervention Once Weekly; Intervention Twice Weekly

Placebo OTHER

Placebo; tablet; oral

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

Nationwide Enrollment via Internet, please email: covid19@umn.edu

Minneapolis, Minnesota, 55455, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

• 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; COVID PREP team. Hydroxychloroquine as Pre-exposure Prophylaxis for Coronavirus Disease 2019 (COVID-19) in Healthcare Workers: A Randomized Trial. Clin Infect Dis. 2021 Jun 1;72(11):e835-e843. doi: 10.1093/cid/ciaa1571.

  PMID: 33068425 RESULT

• Lofgren SM, Nicol MR, Bangdiwala AS, Pastick KA, Okafor EC, Skipper CP, Pullen MF, Engen NW, Abassi M, Williams DA, Nascene AA, Axelrod ML, Lother SA, MacKenzie LJ, Drobot G, Marten N, Cheng MP, Zarychanski R, Schwartz IS, Silverman M, Chagla Z, Kelly LE, McDonald EG, Lee TC, Hullsiek KH, Boulware DR, Rajasingham R. Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19. Open Forum Infect Dis. 2020 Oct 19;7(11):ofaa500. doi: 10.1093/ofid/ofaa500. eCollection 2020 Nov.

  PMID: 33204764 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Respiratory Distress Syndrome

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Radha Rajasingham, MD
• Organization: University of Minnesota

radha@umn.edu

612-626-8171

Study Officials

• Radha Rajasingham, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: April 6, 2020
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: July 2, 2021
• Results First Posted: June 30, 2021

Record last verified: 2021-06

Locations

US (2)