A Study of Combination Therapies to Treat COVID-19 Infection

Sponsor
ProgenaBiome (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04459702
Collaborator
Big Corona Ltd. (Other)
0
1
2
17
0

Study Details

Study Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection
Anticipated Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dual Therapy

Dual Therapy utilizing hydroxychloroquine and azithromycin.

Drug: hydroxychloroquine
Treatment with the drug hydroxychloroquine
Other Names:
  • Plaquenil
  • Drug: Azithromycin
    Treatment with the drug azithromycin
    Other Names:
  • Zithromax
  • Experimental: Quadruple Therapy

    Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin

    Drug: hydroxychloroquine
    Treatment with the drug hydroxychloroquine
    Other Names:
  • Plaquenil
  • Drug: Azithromycin
    Treatment with the drug azithromycin
    Other Names:
  • Zithromax
  • Drug: Ritonavir
    Treatment with the drug ritonavir
    Other Names:
  • norvir
  • Drug: Lopinavir
    Treatment with the drug lopinavir

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Efficacy of Treatment by Time to Non-Infectivity [10 days]

      Time to non-infectivity as measured by PCR testing

    Secondary Outcome Measures

    1. 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.

    2. 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.

    3. Safety of Dual Therapy as Measured by Complete Blood Count [6 months]

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

    4. Safety of Quadruple Therapy as Measured by Complete Blood Count [6 months]

      Changes in blood parameters measured in a Complete Metabolic Panel.

    5. Safety of Dual Therapy as Measured by Metabolic Panel -Albumin [6 months]

      Changes in serum albumin levels

    6. Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin [6 months]

      Changes in serum albumin levels

    7. Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio [6 months]

      Changes in serum albumin/globulin ratio

    8. Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio [6 months]

      Changes in serum albumin/globulin ratio

    9. Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase [6 months]

      Changes in serum alkaline phosphatase levels

    10. Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase [6 months]

      Changes in serum alkaline phosphatase levels

    11. Safety of Dual Therapy as Measured by Metabolic Panel - AST [6 months]

      Changes in serum AST levels

    12. Safety of Quadruple Therapy as Measured by Metabolic Panel - AST [6 months]

      Changes in serum AST levels

    13. Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT [6 months]

      Changes in serum ALT levels

    14. Safety of Dual Therapy as Measured by Metabolic Panel ALT [6 months]

      Changes in serum ALT levels

    15. Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio [6 months]

      Changes in serum BUN/Creatinine Ratio

    16. Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio [6 months]

      Changes in serum BUN/Creatinine Ratio

    17. Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN [6 months]

      Changes in serum Blood Urea Nitrogen levels

    18. Safety of Dual Therapy as Measured by Metabolic Panel - BUN [6 months]

      Changes in serum Blood Urea Nitrogen levels

    19. Safety of Dual Therapy as Measured by Metabolic Panel - Calcium [6 months]

      Changes in serum calcium levels

    20. Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium [6 months]

      Changes in serum calcium levels

    21. Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide [6 months]

      Changes in serum carbon dioxide levels

    22. Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide [6 months]

      Changes in serum carbon dioxide levels

    23. Safety of Dual Therapy as Measured by Metabolic Panel - Chloride [6 months]

      Changes in serum chloride levels

    24. Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride [6 months]

      Changes in serum chloride levels

    25. Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine [6 months]

      Changes in serum creatinine levels

    26. Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine [6 months]

      Changes in serum creatinine levels

    27. Safety of Dual Therapy as Measured by Metabolic Panel - Globulin [6 months]

      Changes in serum globulin levels

    28. Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin [6 months]

      Changes in serum globulin levels

    29. Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose [6 months]

      Changes in blood glucose levels

    30. Safety of Dual Therapy as Measured by Metabolic Panel - Glucose [6 months]

      Changes in blood glucose levels

    31. Safety of Dual Therapy as Measured by Metabolic Panel - Potassium [6 months]

      Changes in blood potassium levels

    32. Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium [6 months]

      Changes in blood potassium levels

    33. Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin [6 months]

      Changes in serum total bilirubin levels

    34. Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin [6 months]

      Changes in serum total bilirubin levels

    35. Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein [6 months]

      Changes in serum total protein levels

    36. Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein [6 months]

      Changes in serum total protein levels

    37. 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

    38. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    14. Hypoglycemia

    15. Known G6PD deficiency

    16. Porphyria

    17. Anemia

    18. Neutropenia

    19. Alcoholism

    20. Myasthenia gravis

    21. Skeletal muscle disorders

    22. Maculopathy

    23. Changes in visual field

    24. Liver disease

    25. Psoriasis

    26. History of QT >500msec

    27. History of torsades de pointes

    28. Anemia from pyruvate kinase and G6PD deficiencies

    29. Abnormal EKG with QT prolongation acquired or from birth

    30. History of jaundice or high fevers prior to developing COVID-19

    31. Treatment with any of the medications listed in Appendix II

    32. Treatment with any anti-epileptic medication

    33. Treatment with any other drug not listed that affects the QT interval

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ProgenaBiome Ventura California United States 93003

    Sponsors and Collaborators

    • ProgenaBiome
    • Big Corona Ltd.

    Investigators

    • Principal Investigator: Sabine Hazan, MD, ProgenaBiome
    • Principal Investigator: Thomas Borody, MD, PhD,, Big Corona Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ProgenaBiome
    ClinicalTrials.gov Identifier:
    NCT04459702
    Other Study ID Numbers:
    • PRG-043
    First Posted:
    Jul 7, 2020
    Last Update Posted:
    Apr 8, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 8, 2021