Not provided
Not provided
Not provided
Not provided
Not provided
Concerned about the adverse effects of HCQ
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Few studies have reported the efficacy of HCQ in reducing the viral load and improving the severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection. However, the prophylactic benefits of HCQ has not been clearly defined yet.
This study is designed to evaluate the prophylactic efficacy of HCQ in COVID-19 cases with mild to moderate symptoms and in the hospital staff engaged in attending infected patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCQ arm | Active Comparator | COVID-19 positive cases will receive receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course. Staff randomized to this group will receive HCQ sulfate 400 mg/week for 4 weeks |
|
| No-HCQ arm | No Intervention | Will receive standard treatment as needed, but no HCQ |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine Sulfate | Drug | Patients will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course. Staff will receive HCQ sulfate 400mg/week for 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach normal body temperature | Time to reach normal body temperature (TNBT), ≤37.50 C | 1 month |
| Development of COVID-19 symptoms during HCQ preventive therapy in staff | Development of fever and/or other symptoms of COVID-19 during the 1 month of the HCQ therapy | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 test result at follow-up in patients | Viral RNA test results at day 6 will be compared between the HCQ vs no-HCQ group | 6 days |
| Worsening of symptoms in COVID-19 patients | Worsening of symptoms in COVID-19 patients requiring artificial ventilation during the study period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrea Natale, MD | St. David's Medical Center | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Symptomatic patients will be randomized to hydroxychloroquine (HCQ) vs no-HCQ group.
Similarly, hospital staff with high risk of exposure will be randomized to HCQ vs no-HCQ group
Not provided
Not provided
Not provided
| 1 month |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |