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

    Phase 2
  • Study Type

  • Status

  • Study Participants

This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.
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 Started
Jul 31
Primary Completion
Jul 31
Study Completion
Dec 31
Last Update
Apr 08

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

Dual Therapy Experimental

Dual Therapy utilizing hydroxychloroquine and azithromycin.

Quadruple Therapy Experimental

Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin


Inclusion Criteria:

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

Exclusion Criteria:

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
Any comorbidities which constitute health risk for the subject
Pregnant or lactating females;
weight < 110lb;
established retinal disease
Inability to attend daily for 10 days

Any contraindications for treatment with hydroxychloroquine

Known G6PD deficiency
Myasthenia gravis
Skeletal muscle disorders
Changes in visual field
Liver disease
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
No Results Posted