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| Name | Class |
|---|---|
| Big Corona Ltd. | UNKNOWN |
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This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.
In this study, patients will be administered either dual or quadruple therapy and have PCR tests run daily to determine efficacy as indicated by time to non-infectivity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Therapy | Experimental | Dual Therapy utilizing hydroxychloroquine and azithromycin. |
|
| Quadruple Therapy | Experimental | Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydroxychloroquine | Drug | Treatment with the drug hydroxychloroquine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores | Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk. | 6 months |
| Efficacy of Treatment by Time to Non-Infectivity | Time to non-infectivity as measured by PCR testing | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores | Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk. |
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Inclusion Criteria:
Exclusion Criteria:
Refusal to sign informed consent form
Negative test for COVID-19 by RT-PCR at screening
Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature > 38 degrees; pleuritic pain, or frequent cough.
Known drug allergy to any of the investigational medications
Currently taking medication with known drug interactions with investigational medications (listed in appendix)
Prescription or other antiviral medications
Any comorbidities which constitute health risk for the subject
Pregnant or lactating females;
weight < 110lb;
porphyria
established retinal disease
Inability to attend daily for 10 days
Any contraindications for treatment with hydroxychloroquine
Anemia from pyruvate kinase and G6PD deficiencies
Abnormal EKG with QT prolongation acquired or from birth
History of jaundice or high fevers prior to developing COVID-19
Treatment with any of the medications listed in Appendix II
Treatment with any anti-epileptic medication
Treatment with any other drug not listed that affects the QT interval
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Hazan, MD | ProgenaBiome | Principal Investigator |
| Thomas Borody, MD, PhD, | Big Corona Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProgenaBiome | Ventura | California | 93003 | United States |
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| Azithromycin | Drug | Treatment with the drug azithromycin |
|
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| Ritonavir | Drug | Treatment with the drug ritonavir |
|
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| Lopinavir | Drug | Treatment with the drug lopinavir |
|
| 6 months |
| Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores. | Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk. | 6 months |
| Safety of Dual Therapy as Measured by Complete Blood Count | Changes in blood parameters measured in a Complete Blood Count (CBC). | 6 months |
| Safety of Quadruple Therapy as Measured by Complete Blood Count | Changes in blood parameters measured in a Complete Metabolic Panel. | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel -Albumin | Changes in serum albumin levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin | Changes in serum albumin levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio | Changes in serum albumin/globulin ratio | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio | Changes in serum albumin/globulin ratio | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase | Changes in serum alkaline phosphatase levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase | Changes in serum alkaline phosphatase levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel - AST | Changes in serum AST levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - AST | Changes in serum AST levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT | Changes in serum ALT levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel ALT | Changes in serum ALT levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio | Changes in serum BUN/Creatinine Ratio | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio | Changes in serum BUN/Creatinine Ratio | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN | Changes in serum Blood Urea Nitrogen levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel - BUN | Changes in serum Blood Urea Nitrogen levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel - Calcium | Changes in serum calcium levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium | Changes in serum calcium levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide | Changes in serum carbon dioxide levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide | Changes in serum carbon dioxide levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel - Chloride | Changes in serum chloride levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride | Changes in serum chloride levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine | Changes in serum creatinine levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine | Changes in serum creatinine levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel - Globulin | Changes in serum globulin levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin | Changes in serum globulin levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose | Changes in blood glucose levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel - Glucose | Changes in blood glucose levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel - Potassium | Changes in blood potassium levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium | Changes in blood potassium levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin | Changes in serum total bilirubin levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin | Changes in serum total bilirubin levels | 6 months |
| Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein | Changes in serum total protein levels | 6 months |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein | Changes in serum total protein levels | 6 months |
| Safety of Dual Therapy as Measured by Treatment Related SAE | Presence or absence of treatment related serious adverse events Grade III or higher | 6 months |
| Safety of Quadruple Therapy as Measured by Treatment Related SAE | Presence or absence of treatment related serious adverse events Grade III or higher | 6 months |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D017963 | Azithromycin |
| D019438 | Ritonavir |
| D061466 | Lopinavir |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
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