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AzTrials

COVIDPhase 2NCT04459702

A Study of Combination Therapies to Treat COVID-19 Infection

A Phase 2 study testing hydroxychloroquine, Azithromycin and Ritonavir in people with COVID and COVID-19, run by ProgenaBiome at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
COVID, COVID-19, Corona Virus Infection
What is being tested?
hydroxychloroquine, Azithromycin and Ritonavir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2020to Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
  • Healthy, ambulant male or female subjects 18 years of age to 65 years of age
  • Positive test for COVID-19 by RT-PCR at screening
  • 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)
  • Subjects must agree they will do their best to attend the treatment facility daily for 10 days

Who cannot join

  • Refusal to sign informed consent form
  • Negative test for COVID-19 by RT-PCR at screening
  • Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature > 38 degrees; pleuritic pain, or frequent cough.
  • Known drug allergy to any of the investigational medications
  • Currently taking medication with known drug interactions with investigational medications (listed in appendix)
  • Prescription or other antiviral medications
Show all 33Show fewer
  • Any comorbidities which constitute health risk for the subject
  • Pregnant or lactating females;
  • weight < 110lb;
  • porphyria
  • established retinal disease
  • Inability to attend daily for 10 days
  • Any contraindications for treatment with hydroxychloroquine
  • Hypoglycemia
  • Known G6PD deficiency
  • Porphyria
  • Anemia
  • Neutropenia
  • Alcoholism
  • Myasthenia gravis
  • Skeletal muscle disorders
  • Maculopathy
  • Changes in visual field
  • Liver disease
  • Psoriasis
  • History of QT >500msec
  • History of torsades de pointes
  • Anemia from pyruvate kinase and G6PD deficiencies
  • Abnormal EKG with QT prolongation acquired or from birth
  • History of jaundice or high fevers prior to developing COVID-19
  • Treatment with any of the medications listed in Appendix II
  • Treatment with any anti-epileptic medication
  • Treatment with any other drug not listed that affects the QT interval

Trial locations and contacts

1 site in 1 country.

United States1 site

  • ProgenaBiome

    Ventura, California, 93003

Other trials in United States

About this study

Official title: 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.

Read the 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

Being tested
hydroxychloroquine, Azithromycin, Ritonavir, Lopinavir
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hydroxychloroquineDrug

    Also called Plaquenil

    Treatment with the drug hydroxychloroquine

  • AzithromycinDrug

    Also called Zithromax

    Treatment with the drug azithromycin

  • RitonavirDrug

    Also called norvir

    Treatment with the drug ritonavir

  • LopinavirDrug

    Treatment with the drug lopinavir

Study groups in NCT04459702
Study groupRoleWhat they receive
Dual TherapyExperimentalDual Therapy utilizing hydroxychloroquine and azithromycin.
Receives: Drug: hydroxychloroquine; Drug: Azithromycin
Quadruple TherapyExperimentalQuadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin
Receives: Drug: hydroxychloroquine; Drug: Azithromycin; Drug: Ritonavir; Drug: Lopinavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. Efficacy of Treatment by Time to Non-Infectivity

    Time to non-infectivity as measured by PCR testing

    Measured: 10 days

Secondary outcomes (38)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. Safety of Dual Therapy as Measured by Complete Blood Count

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

    Measured: 6 months

  4. Safety of Quadruple Therapy as Measured by Complete Blood Count

    Changes in blood parameters measured in a Complete Metabolic Panel.

    Measured: 6 months

  5. Safety of Dual Therapy as Measured by Metabolic Panel -Albumin

    Changes in serum albumin levels

    Measured: 6 months

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

    Changes in serum albumin levels

    Measured: 6 months

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

    Changes in serum albumin/globulin ratio

    Measured: 6 months

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

    Changes in serum albumin/globulin ratio

    Measured: 6 months

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

    Changes in serum alkaline phosphatase levels

    Measured: 6 months

  10. Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase

    Changes in serum alkaline phosphatase levels

    Measured: 6 months

  11. Safety of Dual Therapy as Measured by Metabolic Panel - AST

    Changes in serum AST levels

    Measured: 6 months

  12. Safety of Quadruple Therapy as Measured by Metabolic Panel - AST

    Changes in serum AST levels

    Measured: 6 months

  13. Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT

    Changes in serum ALT levels

    Measured: 6 months

  14. Safety of Dual Therapy as Measured by Metabolic Panel ALT

    Changes in serum ALT levels

    Measured: 6 months

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

    Changes in serum BUN/Creatinine Ratio

    Measured: 6 months

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

    Changes in serum BUN/Creatinine Ratio

    Measured: 6 months

  17. Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN

    Changes in serum Blood Urea Nitrogen levels

    Measured: 6 months

  18. Safety of Dual Therapy as Measured by Metabolic Panel - BUN

    Changes in serum Blood Urea Nitrogen levels

    Measured: 6 months

  19. Safety of Dual Therapy as Measured by Metabolic Panel - Calcium

    Changes in serum calcium levels

    Measured: 6 months

  20. Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium

    Changes in serum calcium levels

    Measured: 6 months

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

    Changes in serum carbon dioxide levels

    Measured: 6 months

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

    Changes in serum carbon dioxide levels

    Measured: 6 months

  23. Safety of Dual Therapy as Measured by Metabolic Panel - Chloride

    Changes in serum chloride levels

    Measured: 6 months

  24. Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride

    Changes in serum chloride levels

    Measured: 6 months

  25. Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine

    Changes in serum creatinine levels

    Measured: 6 months

  26. Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine

    Changes in serum creatinine levels

    Measured: 6 months

  27. Safety of Dual Therapy as Measured by Metabolic Panel - Globulin

    Changes in serum globulin levels

    Measured: 6 months

  28. Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin

    Changes in serum globulin levels

    Measured: 6 months

  29. Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose

    Changes in blood glucose levels

    Measured: 6 months

  30. Safety of Dual Therapy as Measured by Metabolic Panel - Glucose

    Changes in blood glucose levels

    Measured: 6 months

  31. Safety of Dual Therapy as Measured by Metabolic Panel - Potassium

    Changes in blood potassium levels

    Measured: 6 months

  32. Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium

    Changes in blood potassium levels

    Measured: 6 months

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

    Changes in serum total bilirubin levels

    Measured: 6 months

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

    Changes in serum total bilirubin levels

    Measured: 6 months

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

    Changes in serum total protein levels

    Measured: 6 months

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

    Changes in serum total protein levels

    Measured: 6 months

  37. Safety of Dual Therapy as Measured by Treatment Related SAE

    Presence or absence of treatment related serious adverse events Grade III or higher

    Measured: 6 months

  38. Safety of Quadruple Therapy as Measured by Treatment Related SAE

    Presence or absence of treatment related serious adverse events Grade III or higher

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study startJul 2020 (estimated)
  3. Primary completionJul 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Why it stopped: Was never started

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459702
Sponsor's protocol ID
PRG-043
Status last verified
Apr 2021
First submitted
25 Jun 2020
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hydroxychloroquine, Azithromycin and Ritonavir in people with COVID and COVID-19, run by ProgenaBiome at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04459702.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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