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PI withdrew the submission to the IRB
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Given the high prevalence of COVID19 illness (both SARS-CoV-2 RT-PCR confirmed and highly suspect cases) among healthcare workers (HCW) within the Montefiore Health System (MHS), hydroxychloroquine (HCQ) will be prescribed to healthcare workers who are at the highest risk for severe COVID19 illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Eligible participants will be offered the standard Montefiore HCQ dosing regimen of 400mg every 12 hours x 24 hours, then 400mg daily for remaining 4 days and complete a survey study |
|
| Control Group | No Intervention | Participants who opt not to receive the study drug will also be invited to participate in the survey study assessing COVID19 symptoms |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | 400 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of symptoms | Time that it takes for symptoms to be resolved in those who were treated vs untreated | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days from onset of illness to symptom resolution | up to 4 weeks | |
| Number of days to return to work | up to 4 weeks | |
| Rate of hospital admission in treated and untreated healthcare workers |
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Inclusion Criteria:
Symptomatic with COVID illness (either RT-PCR test confirmed or highly suspect clinical symptoms)
Call into office within the first 7 days of illness
Have any of the following high risk conditions:
Experiencing at least one of the following high risk symptoms:
Exclusion Criteria:
• HCW not meeting high-risk criteria or those with a contraindication to HCQ will not be offered HCQ
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| Name | Affiliation | Role |
|---|---|---|
| Priya Nori, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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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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| up to 4 weeks |
| Adverse effect of HCQ during treatment | up to 5 days |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |