Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection

COVID-19 Clinical Trial

Official title:

Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04372017
• Other study ID #: PEPCOH
• Status: Terminated
• Phase: Phase 3
• Start date: May 14, 2020
• Est. completion date: June 4, 2021

Study information

• Verified date: December 2021
• Source: Sanford Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Inclusion Criteria Cohort A:

• = 18 years old

• Employee of healthcare organization in South Dakota or Sanford Health employee in any location and with exposure to a person with COVID-19 within the last 5 days

• Occupational exposure as determined by the participant's employee health department (i.e. not wearing the proper Personal Protective Equipment (PPE))

• Criteria according to Center for Disease Control (CDC) guidelines

• Community exposure (within 6 feet for at least 15 minutes)

• No current symptoms attributable to COVID-19, per HCW report (fever, cough, difficulty breathing, sore throat)

• No prior COVID-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)

• Ability to provide informed consent

Inclusion Criteria - Cohort B

• = 18 years old

• High-risk person who had close contact (i.e. within 6 feet for at least 15 minutes) with a COVID-19 positive person within the last 5 days and is a South Dakota resident or high-risk person with close household contact of a COVID-19 positive Sanford employee

• High-risk person defined by:

• Age 18-44 with 2 or more comorbidities listed below

• Age 45-79 with any comorbid condition listed below

• Age 80 and above (regardless of comorbid conditions)

• Co-morbid list

• Congestive Heart Failure (CHF)

• Chronic lung disease (Includes any of the following: asthma, chronic obstructive pulmonary disease, emphysema)

• Solid organ transplant or immunosuppression (Defined as an outpatient prescription of greater than 10 mg/day of prednisone or equivalent, use of chemotherapy, or use of immunosuppressive agents for solid organ transplant or for an autoimmune disease.)

• Chronic Kidney Disease or End Stage Renal Disease

• Diabetes mellitus

• Cardiovascular disease/Hypertension

• Smoking/Vaping (currently using or history of using in the past 1 year)

• Obesity (calculated by height and weight per participant report)

• Hyperlipidemia

• No current symptoms attributable to COVID-19

• No prior COVID-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)

• Ability to provide informed consent

• Confirmed review of concomitant medications (with emphasis on cardiac medications)

Exclusion Criteria Cohort A & B:

• Known allergy to hydroxychloroquine or quinine

• Known history of long QT syndrome

• Known history of arrhythmia or dysrhythmia

• Known current QTc >500 ms

• Known G6PD deficiency

• Known history of hypoglycemia

• Pregnant or Nursing by patient history

• Use of any of the following concomitant medications: See Appendix D for Exclusion medication list

• Concurrent diagnosis of dermatitis, porphyria, or psoriasis

• History of chronic liver disease, including cirrhosis and/or diagnosis of hepatitis (infectious, idiopathic, or immune)

• History of chronic kidney disease

• Pre-existing retinopathy

• Already taking hydroxychloroquine

• Any condition or medication in the opinion of the investigator that would prohibit the use of hydroxychloroquine

• Enrollment in another clinical with investigational drug or device

• Inability to swallow pills

• Adults unable to provide informed consent

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV 2

Intervention

Drug:
• Hydroxychloroquine
Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.

Dietary Supplement:
• Vitamin D
Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.

Locations

Country	Name	City	State
United States	Sanford Health	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Sanford Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort A: Percentage of COVID-19 Exposed Healthcare Workers Treated With Hydroxychloroquine With a Positive COVID-19 Test.	Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in healthcare workers who have been exposed to a known case of COVID-19.	At enrollment completion outcome 1 will be analyzed.
Primary	Cohort B: Percentage of COVID-19 Exposed High-risk Individuals Treated With Hydroxychloroquine With a Positive COVID-19 Test.	Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in high-risk individuals who have been exposed to a known case of COVID-19.	At enrollment completion outcome 2 will be analyzed.