A Study of Combination Therapies to Treat COVID-19 Infection

ProgenaBiome

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

COVID COVID-19 Corona Virus Infection Coronavirus Infection Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere Coronavirus-19 SARS-CoV 2 SARS Pneumonia

Interventions

hydroxychloroquineDRUG

Treatment with the drug hydroxychloroquine

AzithromycinDRUG

Treatment with the drug azithromycin

RitonavirDRUG

Treatment with the drug ritonavir

Lopinavir

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

ProgenaBiome

Ventura, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Efficacy of Treatment by Time to Non-Infectivity

Time to non-infectivity as measured by PCR testing

Time frame: 10 days

Secondary Outcomes

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.

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores.

Time frame: 6 months

Safety of Dual Therapy as Measured by Complete Blood Count

Changes in blood parameters measured in a Complete Blood Count (CBC).

Time frame: 6 months

Data from ClinicalTrials.gov

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Treatment with the drug lopinavir

Safety of Quadruple Therapy as Measured by Complete Blood Count

Changes in blood parameters measured in a Complete Metabolic Panel.

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel -Albumin

Changes in serum albumin levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin

Changes in serum albumin levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio

Changes in serum albumin/globulin ratio

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio

Changes in serum albumin/globulin ratio

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase

Changes in serum alkaline phosphatase levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase

Changes in serum alkaline phosphatase levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel - AST

Changes in serum AST levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - AST

Changes in serum AST levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT

Changes in serum ALT levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel ALT

Changes in serum ALT levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio

Changes in serum BUN/Creatinine Ratio

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio

Changes in serum BUN/Creatinine Ratio

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN

Changes in serum Blood Urea Nitrogen levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel - BUN

Changes in serum Blood Urea Nitrogen levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel - Calcium

Changes in serum calcium levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium

Changes in serum calcium levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide

Changes in serum carbon dioxide levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide

Changes in serum carbon dioxide levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel - Chloride

Changes in serum chloride levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride

Changes in serum chloride levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine

Changes in serum creatinine levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine

Changes in serum creatinine levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel - Globulin

Changes in serum globulin levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin

Changes in serum globulin levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose

Changes in blood glucose levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel - Glucose

Changes in blood glucose levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel - Potassium

Changes in blood potassium levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium

Changes in blood potassium levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin

Changes in serum total bilirubin levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin

Changes in serum total bilirubin levels

Time frame: 6 months

Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein

Changes in serum total protein levels

Time frame: 6 months

Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein

Changes in serum total protein levels

Time frame: 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

Time frame: 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

Time frame: 6 months