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Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Hydroxychloroquine; 200mg tablet; oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidence of Possible COVID-19 Symptoms |
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Inclusion Criteria:
- A healthcare worker at high risk for COVID-19 exposure (defined below):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Radha Rajasingham, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Enrollment via Internet, please email: covid19@umn.edu | Minneapolis | Minnesota | 55455 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33068425 | Result | 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. | |
| 33204764 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Once Weekly | 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 Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral |
| FG001 | Intervention Twice Weekly | 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 Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral |
| FG002 | Control Group | 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 Placebo: Placebo; tablet; oral |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Once Weekly | 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 Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral |
| BG001 | Intervention Twice Weekly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | up to 12 weeks |
|
up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Once Weekly | 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 Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hysteroscopy | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Radha Rajasingham, MD | University of Minnesota | 612-626-8171 | radha@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2020 | Jun 25, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2020 | May 5, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Placebo | Other | Placebo; tablet; oral |
|
Outcome reported as the count of participants in each arm who report COVID-19-related symptoms during study treatment.
| up to 12 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| University of Minnesota |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Derived |
| 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. |
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 Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral |
| BG002 | Control Group | 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 Placebo: Placebo; tablet; oral |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Control Group | 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 Placebo: Placebo; tablet; oral |
|
|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Measure was only collected for one participant in the twice-weekly intervention group and one participant in the control group. No participants in the once-weekly intervention group were sampled for this measure. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| 0 |
| 494 |
| 3 |
| 494 |
| 0 |
| 494 |
| EG001 | Intervention Twice Weekly | 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 Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral | 0 | 495 | 6 | 495 | 0 | 495 |
| EG002 | Control Group | 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 Placebo: Placebo; tablet; oral | 0 | 494 | 8 | 494 | 0 | 494 |
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
|
| Spinal Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Elective Coronary Angiogram | Surgical and medical procedures | Systematic Assessment |
|
| Gall Bladder Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Motor Vehicle Accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Heart Palpitations | Cardiac disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hyperthyroid | Endocrine disorders | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Sarcoidosis Biopsy | Surgical and medical procedures | Systematic Assessment |
|
| Other Not Specified | General disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |