A Study of Combination Therapies to Treat COVID-19 Infection

April 6, 2021 updated by: ProgenaBiome

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • ProgenaBiome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores
Time Frame: 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.
6 months
Efficacy of Treatment by Time to Non-Infectivity
Time Frame: 10 days
Time to non-infectivity as measured by PCR testing
10 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores
Time Frame: 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.
6 months
Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores.
Time Frame: 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.
6 months
Safety of Dual Therapy as Measured by Complete Blood Count
Time Frame: 6 months
Changes in blood parameters measured in a Complete Blood Count (CBC).
6 months
Safety of Quadruple Therapy as Measured by Complete Blood Count
Time Frame: 6 months
Changes in blood parameters measured in a Complete Metabolic Panel.
6 months
Safety of Dual Therapy as Measured by Metabolic Panel -Albumin
Time Frame: 6 months
Changes in serum albumin levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin
Time Frame: 6 months
Changes in serum albumin levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio
Time Frame: 6 months
Changes in serum albumin/globulin ratio
6 months
Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio
Time Frame: 6 months
Changes in serum albumin/globulin ratio
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase
Time Frame: 6 months
Changes in serum alkaline phosphatase levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase
Time Frame: 6 months
Changes in serum alkaline phosphatase levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel - AST
Time Frame: 6 months
Changes in serum AST levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - AST
Time Frame: 6 months
Changes in serum AST levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT
Time Frame: 6 months
Changes in serum ALT levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel ALT
Time Frame: 6 months
Changes in serum ALT levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio
Time Frame: 6 months
Changes in serum BUN/Creatinine Ratio
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio
Time Frame: 6 months
Changes in serum BUN/Creatinine Ratio
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN
Time Frame: 6 months
Changes in serum Blood Urea Nitrogen levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel - BUN
Time Frame: 6 months
Changes in serum Blood Urea Nitrogen levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Calcium
Time Frame: 6 months
Changes in serum calcium levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium
Time Frame: 6 months
Changes in serum calcium levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide
Time Frame: 6 months
Changes in serum carbon dioxide levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide
Time Frame: 6 months
Changes in serum carbon dioxide levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Chloride
Time Frame: 6 months
Changes in serum chloride levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride
Time Frame: 6 months
Changes in serum chloride levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine
Time Frame: 6 months
Changes in serum creatinine levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine
Time Frame: 6 months
Changes in serum creatinine levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Globulin
Time Frame: 6 months
Changes in serum globulin levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin
Time Frame: 6 months
Changes in serum globulin levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose
Time Frame: 6 months
Changes in blood glucose levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Glucose
Time Frame: 6 months
Changes in blood glucose levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Potassium
Time Frame: 6 months
Changes in blood potassium levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium
Time Frame: 6 months
Changes in blood potassium levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin
Time Frame: 6 months
Changes in serum total bilirubin levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin
Time Frame: 6 months
Changes in serum total bilirubin levels
6 months
Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein
Time Frame: 6 months
Changes in serum total protein levels
6 months
Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein
Time Frame: 6 months
Changes in serum total protein levels
6 months
Safety of Dual Therapy as Measured by Treatment Related SAE
Time Frame: 6 months
Presence or absence of treatment related serious adverse events Grade III or higher
6 months
Safety of Quadruple Therapy as Measured by Treatment Related SAE
Time Frame: 6 months
Presence or absence of treatment related serious adverse events Grade III or higher
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ProgenaBiome

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Big Corona Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Borody, MD, PhD,, Big Corona Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRG-043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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