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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
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 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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04459702
Status
Withdrawn
Sponsor
ProgenaBiome

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.