A Study of Combination Therapies to Treat COVID-19 Infection

A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection

Sponsors

Lead Sponsor: ProgenaBiome

Collaborator: Big Corona Ltd.

Source ProgenaBiome
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

Overall Status Withdrawn
Start Date 2020-07-01
Completion Date 2021-12-01
Primary Completion Date 2021-07-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores 6 months
Efficacy of Treatment by Time to Non-Infectivity 10 days
Secondary Outcome
Measure Time Frame
Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores 6 months
Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores. 6 months
Safety of Dual Therapy as Measured by Complete Blood Count 6 months
Safety of Quadruple Therapy as Measured by Complete Blood Count 6 months
Safety of Dual Therapy as Measured by Metabolic Panel -Albumin 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio 6 months
Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase 6 months
Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase 6 months
Safety of Dual Therapy as Measured by Metabolic Panel - AST 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - AST 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT 6 months
Safety of Dual Therapy as Measured by Metabolic Panel ALT 6 months
Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN 6 months
Safety of Dual Therapy as Measured by Metabolic Panel - BUN 6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Calcium 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide 6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide 6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Chloride 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine 6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine 6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Globulin 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose 6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Glucose 6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Potassium 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin 6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin 6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein 6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein 6 months
Safety of Dual Therapy as Measured by Treatment Related SAE 6 months
Safety of Quadruple Therapy as Measured by Treatment Related SAE 6 months
Condition
Intervention

Intervention Type: Drug

Intervention Name: hydroxychloroquine

Description: Treatment with the drug hydroxychloroquine

Other Name: Plaquenil

Intervention Type: Drug

Intervention Name: Azithromycin

Description: Treatment with the drug azithromycin

Other Name: Zithromax

Intervention Type: Drug

Intervention Name: Ritonavir

Description: Treatment with the drug ritonavir

Arm Group Label: Quadruple Therapy

Other Name: norvir

Intervention Type: Drug

Intervention Name: Lopinavir

Description: Treatment with the drug lopinavir

Arm Group Label: Quadruple Therapy

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Location
Facility: ProgenaBiome
Location Countries

United States

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Dual Therapy

Type: Experimental

Description: Dual Therapy utilizing hydroxychloroquine and azithromycin.

Label: Quadruple Therapy

Type: Experimental

Description: Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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