A Study of Combination Therapies to Treat COVID-19 Infection

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04459702
• Other study ID #: PRG-043
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2020
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: ProgenaBiome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infection
• Coronavirus Infections
• Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
• Coronavirus-19
• COVID
• COVID-19
• Infection
• Pneumonia
• SARS Pneumonia
• SARS-CoV 2
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• hydroxychloroquine
Treatment with the drug hydroxychloroquine
• Azithromycin
Treatment with the drug azithromycin
• Ritonavir
Treatment with the drug ritonavir
• Lopinavir
Treatment with the drug lopinavir

Locations

Country	Name	City	State
United States	ProgenaBiome	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
ProgenaBiome	Big Corona Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Efficacy of Treatment by Time to Non-Infectivity	Time to non-infectivity as measured by PCR testing	10 days
Secondary	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.	6 months
Secondary	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
Secondary	Safety of Dual Therapy as Measured by Complete Blood Count	Changes in blood parameters measured in a Complete Blood Count (CBC).	6 months
Secondary	Safety of Quadruple Therapy as Measured by Complete Blood Count	Changes in blood parameters measured in a Complete Metabolic Panel.	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel -Albumin	Changes in serum albumin levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin	Changes in serum albumin levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio	Changes in serum albumin/globulin ratio	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio	Changes in serum albumin/globulin ratio	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase	Changes in serum alkaline phosphatase levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase	Changes in serum alkaline phosphatase levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel - AST	Changes in serum AST levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - AST	Changes in serum AST levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT	Changes in serum ALT levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel ALT	Changes in serum ALT levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio	Changes in serum BUN/Creatinine Ratio	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio	Changes in serum BUN/Creatinine Ratio	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN	Changes in serum Blood Urea Nitrogen levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel - BUN	Changes in serum Blood Urea Nitrogen levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel - Calcium	Changes in serum calcium levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium	Changes in serum calcium levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide	Changes in serum carbon dioxide levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide	Changes in serum carbon dioxide levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel - Chloride	Changes in serum chloride levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride	Changes in serum chloride levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine	Changes in serum creatinine levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine	Changes in serum creatinine levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel - Globulin	Changes in serum globulin levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin	Changes in serum globulin levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose	Changes in blood glucose levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel - Glucose	Changes in blood glucose levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel - Potassium	Changes in blood potassium levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium	Changes in blood potassium levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin	Changes in serum total bilirubin levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin	Changes in serum total bilirubin levels	6 months
Secondary	Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein	Changes in serum total protein levels	6 months
Secondary	Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein	Changes in serum total protein levels	6 months
Secondary	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
Secondary	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