Coronavirus-19, Coronavirus Infection, Corona Virus Infection, Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere, COVID, COVID-19, SARS-CoV 2, SARS Pneumonia
Conditions
Brief summary
This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.
Detailed description
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
Interventions
DRUGhydroxychloroquine
Treatment with the drug hydroxychloroquine
DRUGAzithromycin
Treatment with the drug azithromycin
DRUGRitonavir
Treatment with the drug ritonavir
DRUGLopinavir
Treatment with the drug lopinavir
Sponsors
Big Corona Ltd.
ProgenaBiome
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study 2. Healthy, ambulant male or female subjects 18 years of age to 65 years of age 3. Positive test for COVID-19 by RT-PCR at screening 4. Subjects must agree to practice at least one highly effective method of birth control for the duration of the study. This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized) 5. Subjects must agree they will do their best to attend the treatment facility daily for 10 days
Exclusion criteria
1. Refusal to sign informed consent form 2. Negative test for COVID-19 by RT-PCR at screening 3. Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature \> 38 degrees; pleuritic pain, or frequent cough. 4. Known drug allergy to any of the investigational medications 5. Currently taking medication with known drug interactions with investigational medications (listed in appendix) 6. Prescription or other antiviral medications 7. Any comorbidities which constitute health risk for the subject 8. Pregnant or lactating females; 9. weight \< 110lb; 10. porphyria 11. established retinal disease 12. Inability to attend daily for 10 days 13. Any contraindications for treatment with hydroxychloroquine 1. Hypoglycemia 2. Known G6PD deficiency 3. Porphyria 4. Anemia 5. Neutropenia 6. Alcoholism 7. Myasthenia gravis 8. Skeletal muscle disorders 9. Maculopathy 10. Changes in visual field 11. Liver disease 12. Psoriasis 13. History of QT \>500msec 14. History of torsades de pointes 14. Anemia from pyruvate kinase and G6PD deficiencies 15. Abnormal EKG with QT prolongation acquired or from birth 16. History of jaundice or high fevers prior to developing COVID-19 17. Treatment with any of the medications listed in Appendix II 18. Treatment with any anti-epileptic medication 19. Treatment with any other drug not listed that affects the QT interval
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores | 6 months | 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. |
| Efficacy of Treatment by Time to Non-Infectivity | 10 days | Time to non-infectivity as measured by PCR testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Dual Therapy as Measured by Complete Blood Count | 6 months | Changes in blood parameters measured in a Complete Blood Count (CBC). |
| Safety of Quadruple Therapy as Measured by Complete Blood Count | 6 months | Changes in blood parameters measured in a Complete Metabolic Panel. |
| Safety of Dual Therapy as Measured by Metabolic Panel -Albumin | 6 months | Changes in serum albumin levels |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin | 6 months | Changes in serum albumin levels |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio | 6 months | Changes in serum albumin/globulin ratio |
| Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio | 6 months | Changes in serum albumin/globulin ratio |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase | 6 months | Changes in serum alkaline phosphatase levels |
| Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase | 6 months | Changes in serum alkaline phosphatase levels |
| Safety of Dual Therapy as Measured by Metabolic Panel - AST | 6 months | Changes in serum AST levels |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - AST | 6 months | Changes in serum AST levels |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT | 6 months | Changes in serum ALT levels |
| Safety of Dual Therapy as Measured by Metabolic Panel ALT | 6 months | Changes in serum ALT levels |
| Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio | 6 months | Changes in serum BUN/Creatinine Ratio |
| Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio | 6 months | Changes in serum BUN/Creatinine Ratio |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN | 6 months | Changes in serum Blood Urea Nitrogen levels |
| Safety of Dual Therapy as Measured by Metabolic Panel - BUN | 6 months | Changes in serum Blood Urea Nitrogen levels |
| Safety of Dual Therapy as Measured by Metabolic Panel - Calcium | 6 months | Changes in serum calcium levels |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium | 6 months | Changes in serum calcium levels |
| Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores | 6 months | 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. |
| Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide | 6 months | Changes in serum carbon dioxide levels |
| Safety of Dual Therapy as Measured by Metabolic Panel - Chloride | 6 months | Changes in serum chloride levels |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride | 6 months | Changes in serum chloride levels |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine | 6 months | Changes in serum creatinine levels |
| Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine | 6 months | Changes in serum creatinine levels |
| Safety of Dual Therapy as Measured by Metabolic Panel - Globulin | 6 months | Changes in serum globulin levels |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin | 6 months | Changes in serum globulin levels |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose | 6 months | Changes in blood glucose levels |
| Safety of Dual Therapy as Measured by Metabolic Panel - Glucose | 6 months | Changes in blood glucose levels |
| Safety of Dual Therapy as Measured by Metabolic Panel - Potassium | 6 months | Changes in blood potassium levels |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium | 6 months | Changes in blood potassium levels |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin | 6 months | Changes in serum total bilirubin levels |
| Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin | 6 months | Changes in serum total bilirubin levels |
| Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein | 6 months | Changes in serum total protein levels |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein | 6 months | Changes in serum total protein levels |
| Safety of Dual Therapy as Measured by Treatment Related SAE | 6 months | Presence or absence of treatment related serious adverse events Grade III or higher |
| Safety of Quadruple Therapy as Measured by Treatment Related SAE | 6 months | Presence or absence of treatment related serious adverse events Grade III or higher |
| Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide | 6 months | Changes in serum carbon dioxide levels |
| Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores. | 6 months | 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. |
Countries
United States
Outcome results
None listed