COVID-19Phase 3NCT04372017
Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection
A Phase 3 study testing Hydroxychloroquine and Vitamin D in people with COVID-19 and SARS-CoV 2, run by Sanford Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV 2
- What is being tested?
- Hydroxychloroquine and Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2020to 4 Jun 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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)
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- No prior COVID-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)
- Ability to provide informed consent
- ≥ 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection
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.
- Conditions
- COVID-19, SARS-CoV 2
- Being tested
- Hydroxychloroquine, Vitamin D
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
Vitamin DDietary supplement
Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Healthcare worker (hydroxychloroquine) | Experimental | Not described Receives: Drug: Hydroxychloroquine |
| Cohort A: Healthcare worker (placebo) | Placebo comparator | Not described Receives: Dietary Supplement: Vitamin D |
| Cohort B: High-Risk participant (hydroxychloroqine) | Experimental | Not described Receives: Drug: Hydroxychloroquine |
| Cohort B: High-Risk participant (placebo) | Placebo comparator | Not described Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment completion outcome 1 will be analyzed.
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.
Measured: At enrollment completion outcome 2 will be analyzed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start14 May 2020
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Why it stopped: Unlikelihood of benefit based on other studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Hoover, MD, Study chair, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372017
- Sponsor's protocol ID
- PEPCOH
- Status last verified
- Dec 2021
- First submitted
- 25 Apr 2020
- Last updated
- 10 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04372017
- Acronym / sponsor ID
- PEPCOH
- Conditions
- COVID-19, SARS-CoV 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unlikelihood of benefit based on other studies.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Posted 10 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Healthcare worker (hydroxychloroquine) | Experimental | Drug: Hydroxychloroquine |
| Cohort A: Healthcare worker (placebo) | Placebo comparator | Dietary Supplement: Vitamin D |
| Cohort B: High-Risk participant (hydroxychloroqine) | Experimental | Drug: Hydroxychloroquine |
| Cohort B: High-Risk participant (placebo) | Placebo comparator | Dietary Supplement: Vitamin D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- ≥ 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
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineParticipants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | Drug | Cohort A: Healthcare worker (hydroxychloroquine), Cohort B: High-Risk participant (hydroxychloroqine) |
| Vitamin DParticipants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. | Dietary supplement | Cohort A: Healthcare worker (placebo), Cohort B: High-Risk participant (placebo) |
Primary outcome
Cohort A: Percentage of COVID-19 Exposed Healthcare Workers Treated With Hydroxychloroquine With a Positive COVID-19 Test.
Time frame: At enrollment completion outcome 1 will be analyzed.
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.
Cohort B: Percentage of COVID-19 Exposed High-risk Individuals Treated With Hydroxychloroquine With a Positive COVID-19 Test.
Time frame: At enrollment completion outcome 2 will be analyzed.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Hoover, MD study chair
Sanford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine and Vitamin D in people with COVID-19 and SARS-CoV 2, run by Sanford Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A: Percentage of COVID-19 Exposed Healthcare Workers Treated With Hydroxychloroquine With a Positive COVID-19 Test. (time frame: At enrollment completion outcome 1 will be analyzed.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.