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Poor accrual.
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| Name | Class |
|---|---|
| Mayo Hospital Lahore | OTHER |
| Services Institute of Medical Sciences, Pakistan | OTHER_GOV |
| Pakistan Kidney and Liver Institute | UNKNOWN |
| Forman Christian College, Pakistan |
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To create a protocol for treatment of Pakistani patients with SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different quinone drug dosing regimens in controlling SARS-CoV-2 infection for asymptomatic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care |
|
| Arm 2 | Experimental | Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care |
|
| Arm 3 | Active Comparator | Chloroquine 500 mg BID for 5 days plus standard of care |
|
| Arm 4 | Placebo Comparator | Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine Sulfate Regular dose | Drug | Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| RT-PCR negative status | Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7 | 6-7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of symptoms | Time to progression to next stage of SARS-CoV-2 disease severity index | 7 days |
| Development of Symptoms | Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Expo Covid Center | Lahore | Punjab Province | Pakistan | |||
| Mayo Hospital |
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| OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
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| Hydroxychloroquine Sulfate Loading Dose | Drug | Hydroxychloroquine administered as a loading dose only |
|
| Chloroquine | Drug | Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2 |
|
| Placebo | Drug | Standard of Care plus placebo |
|
| 7 days |
| Adverse events | Drug related adverse events as determined by data safety and monitoring board (DSMB) | 7 days |
| Lahore |
| Punjab Province |
| Pakistan |
| Pakistan Kidney and Liver Institute | Lahore | Punjab Province | Pakistan |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D058070 | Asymptomatic Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002738 | Chloroquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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